Trial Outcomes & Findings for Intranasal Insulin for the Treatment of HAND (NCT NCT03081117)
NCT ID: NCT03081117
Last Updated: 2021-07-07
Results Overview
Number of documented serious adverse events per participant, mean
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Total during 24-week trial
Results posted on
2021-07-07
Participant Flow
Participant milestones
| Measure |
Insulin, Intranasal
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
Primary Outcome 1 (SAE)
|
10
|
11
|
|
Overall Study
Secondary Measures Collected at Week 24
|
8
|
9
|
|
Overall Study
Completed (ITT): Primary Outcome 2 (GDS)
|
7
|
9
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
Baseline characteristics by cohort
| Measure |
Insulin, Intranasal
n=10 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=11 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Enrolled
|
58.5 years
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
58 years
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
58 years
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Continuous
Completed Trial (ITT)
|
57 years
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
58 years
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
57.5 years
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Continuous
Completed Trial (Per Protocol)
|
56 years
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
57.5 years
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
57 years
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Enrolled · 30-39
|
1 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
0 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Enrolled · 40-49
|
0 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Enrolled · 50-59
|
5 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
10 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Enrolled · 60-69
|
4 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
9 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Completed Trial (ITT) · 30-39
|
1 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
0 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Completed Trial (ITT) · 40-49
|
0 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Completed Trial (ITT) · 50-59
|
4 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
9 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Completed Trial (ITT) · 60-69
|
2 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
3 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Completed Trial (Per Protocol) · 30-39
|
1 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
0 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Completed Trial (Per Protocol) · 40-49
|
0 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Completed Trial (Per Protocol) · 50-59
|
4 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
9 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Age, Customized
Completed Trial (Per Protocol) · 60-69
|
1 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
2 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
3 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Sex: Female, Male
Enrolled · Female
|
3 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
8 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Sex: Female, Male
Enrolled · Male
|
7 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
6 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
13 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Sex: Female, Male
Completed Trial (ITT) · Female
|
3 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
4 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
7 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Sex: Female, Male
Completed Trial (ITT) · Male
|
4 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
9 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Sex: Female, Male
Completed Trial (Per Protocol) · Female
|
3 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
3 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
6 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Sex: Female, Male
Completed Trial (Per Protocol) · Male
|
3 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
8 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=10 Participants
|
10 Participants
n=11 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
21 participants
n=21 Participants
|
|
Education, Continuous
Enrolled
|
12.70 years
STANDARD_DEVIATION 2.06 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
12.09 years
STANDARD_DEVIATION 1.87 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
12.38 years
STANDARD_DEVIATION 1.94 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Continuous
Completed Trial (ITT)
|
12.86 years
STANDARD_DEVIATION 2.34 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
12.33 years
STANDARD_DEVIATION 1.94 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
12.56 years
STANDARD_DEVIATION 2.06 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Continuous
Completed Trial (Per Protocol)
|
12.33 years
STANDARD_DEVIATION 2.07 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
12.50 years
STANDARD_DEVIATION 2.00 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
12.43 years
STANDARD_DEVIATION 1.95 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Enrolled · 9th to 11th Grade
|
2 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
3 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Enrolled · High School Diploma
|
4 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
6 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
10 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Enrolled · Some College or Associates Degree
|
3 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
4 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Enrolled · College Degree
|
1 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
2 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Completed Trial (ITT) · 9th to 11th Grade
|
1 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
2 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
3 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Completed Trial (ITT) · High School Diploma
|
3 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
8 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Completed Trial (ITT) · Some College or Associates Degree
|
2 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
3 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Completed Trial (ITT) · College Degree
|
1 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
2 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Completed Trial (Per Protocol) · 9th to 11th Grade
|
1 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
2 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Completed Trial (Per Protocol) · High School Diploma
|
3 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
8 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Completed Trial (Per Protocol) · Some College or Associates Degree
|
2 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
3 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Education, Categorical
Completed Trial (Per Protocol) · College Degree
|
0 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Global Deficit Score (GDS), Baseline
Enrolled
|
1.37 units on a scale
STANDARD_DEVIATION 0.74 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
0.85 units on a scale
STANDARD_DEVIATION 0.57 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1.10 units on a scale
STANDARD_DEVIATION 0.70 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Global Deficit Score (GDS), Baseline
Completed Trial (ITT)
|
1.31 units on a scale
STANDARD_DEVIATION 0.56 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
0.75 units on a scale
STANDARD_DEVIATION 0.47 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1.00 units on a scale
STANDARD_DEVIATION 0.57 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Global Deficit Score (GDS), Baseline
Completed Trial (Per Protocol)
|
1.22 units on a scale
STANDARD_DEVIATION 0.55 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
0.77 units on a scale
STANDARD_DEVIATION 0.50 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
0.97 units on a scale
STANDARD_DEVIATION 0.55 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Beck Depression Inventory II
Enrolled
|
11.0 units on a scale
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
6.0 units on a scale
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
6.0 units on a scale
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Beck Depression Inventory II
Completed Trial (ITT)
|
13.0 units on a scale
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
4.0 units on a scale
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5.0 units on a scale
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Beck Depression Inventory II
Completed Trial (Per Protocol)
|
13.5 units on a scale
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5.0 units on a scale
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
7.5 units on a scale
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Estimated IQ, Hopkins Adult Reading Test
Enrolled
|
97.13 units on a scale
STANDARD_DEVIATION 6.64 • n=8 Participants • Two participants did not perform the Hopkins Adult Reading Test at baseline. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
96.00 units on a scale
STANDARD_DEVIATION 11.54 • n=11 Participants • Two participants did not perform the Hopkins Adult Reading Test at baseline. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
96.47 units on a scale
STANDARD_DEVIATION 9.56 • n=19 Participants • Two participants did not perform the Hopkins Adult Reading Test at baseline. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Estimated IQ, Hopkins Adult Reading Test
Completed Trial (ITT)
|
98.67 units on a scale
STANDARD_DEVIATION 6.50 • n=6 Participants • Two participants did not perform the Hopkins Adult Reading Test at baseline. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
97.67 units on a scale
STANDARD_DEVIATION 12.22 • n=9 Participants • Two participants did not perform the Hopkins Adult Reading Test at baseline. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
98.07 units on a scale
STANDARD_DEVIATION 10.03 • n=15 Participants • Two participants did not perform the Hopkins Adult Reading Test at baseline. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Estimated IQ, Hopkins Adult Reading Test
Completed Trial (Per Protocol)
|
98.80 units on a scale
STANDARD_DEVIATION 7.26 • n=5 Participants • Two participants did not perform the Hopkins Adult Reading Test at baseline. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
98.63 units on a scale
STANDARD_DEVIATION 12.69 • n=8 Participants • Two participants did not perform the Hopkins Adult Reading Test at baseline. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
98.69 units on a scale
STANDARD_DEVIATION 10.56 • n=13 Participants • Two participants did not perform the Hopkins Adult Reading Test at baseline. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Hopkins Verbal Learning Test, Total (Trials 1-3)
Enrolled
|
-1.41 z-score
STANDARD_DEVIATION 1.00 • n=10 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.96 z-score
STANDARD_DEVIATION 0.82 • n=11 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.18 z-score
STANDARD_DEVIATION 0.92 • n=21 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Hopkins Verbal Learning Test, Total (Trials 1-3)
Completed Trial (ITT)
|
-1.56 z-score
STANDARD_DEVIATION 1.15 • n=7 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.01 z-score
STANDARD_DEVIATION 0.91 • n=9 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.25 z-score
STANDARD_DEVIATION 1.02 • n=16 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Hopkins Verbal Learning Test, Total (Trials 1-3)
Completed Trial (Per Protocol)
|
-1.34 z-score
STANDARD_DEVIATION 1.09 • n=6 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.84 z-score
STANDARD_DEVIATION 0.80 • n=8 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.06 z-score
STANDARD_DEVIATION 0.93 • n=14 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Hopkins Verbal Learning Test, Delayed Recall
Enrolled
|
-2.00 z-score
STANDARD_DEVIATION 1.50 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.20 z-score
STANDARD_DEVIATION 0.98 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.58 z-score
STANDARD_DEVIATION 1.29 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Hopkins Verbal Learning Test, Delayed Recall
Completed Trial (ITT)
|
-2.10 z-score
STANDARD_DEVIATION 1.74 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.93 z-score
STANDARD_DEVIATION 0.67 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.44 z-score
STANDARD_DEVIATION 1.34 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Hopkins Verbal Learning Test, Delayed Recall
Completed Trial (Per Protocol)
|
-1.89 z-score
STANDARD_DEVIATION 1.80 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.88 z-score
STANDARD_DEVIATION 0.70 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.31 z-score
STANDARD_DEVIATION 1.33 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Rey Complex Figure Test, Copy
Enrolled
|
-2.20 z-score
STANDARD_DEVIATION 1.32 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.15 z-score
STANDARD_DEVIATION 1.14 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.65 z-score
STANDARD_DEVIATION 1.31 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Rey Complex Figure Test, Copy
Completed Trial (ITT)
|
-2.39 z-score
STANDARD_DEVIATION 1.25 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.12 z-score
STANDARD_DEVIATION 1.27 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.67 z-score
STANDARD_DEVIATION 1.38 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Rey Complex Figure Test, Copy
Completed Trial (Per Protocol)
|
-2.20 z-score
STANDARD_DEVIATION 1.26 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.91 z-score
STANDARD_DEVIATION 1.20 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-1.47 z-score
STANDARD_DEVIATION 1.35 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Rey Complex Figure Test, Delayed Recall
Enrolled
|
-0.87 z-score
STANDARD_DEVIATION 0.95 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.46 z-score
STANDARD_DEVIATION 0.91 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.65 z-score
STANDARD_DEVIATION 0.93 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Rey Complex Figure Test, Delayed Recall
Completed Trial (ITT)
|
-0.63 z-score
STANDARD_DEVIATION 0.92 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.27 z-score
STANDARD_DEVIATION 0.90 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.43 z-score
STANDARD_DEVIATION 0.90 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Rey Complex Figure Test, Delayed Recall
Completed Trial (Per Protocol)
|
-0.46 z-score
STANDARD_DEVIATION 0.87 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.19 z-score
STANDARD_DEVIATION 0.93 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.31 z-score
STANDARD_DEVIATION 0.88 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Trail Making Test, Part A
Enrolled
|
-0.94 z-score
STANDARD_DEVIATION 0.61 • n=10 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.02 z-score
STANDARD_DEVIATION 0.72 • n=11 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.46 z-score
STANDARD_DEVIATION 0.81 • n=21 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Trail Making Test, Part A
Completed Trial (ITT)
|
-0.91 z-score
STANDARD_DEVIATION 0.48 • n=7 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
0.02 z-score
STANDARD_DEVIATION 0.76 • n=9 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.39 z-score
STANDARD_DEVIATION 0.79 • n=16 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Trail Making Test, Part A
Completed Trial (Per Protocol)
|
-0.88 z-score
STANDARD_DEVIATION 0.52 • n=6 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.16 z-score
STANDARD_DEVIATION 0.56 • n=8 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.47 z-score
STANDARD_DEVIATION 0.64 • n=14 Participants • Measure Analysis Population Description: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Trail Making Test, Part B
Enrolled
|
-0.76 z-score
STANDARD_DEVIATION 0.59 • n=9 Participants • Two participants were unable to complete test in the allotted time. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.23 z-score
STANDARD_DEVIATION 0.64 • n=10 Participants • Two participants were unable to complete test in the allotted time. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.48 z-score
STANDARD_DEVIATION 0.66 • n=19 Participants • Two participants were unable to complete test in the allotted time. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Trail Making Test, Part B
Completed Trial (ITT)
|
-0.66 z-score
STANDARD_DEVIATION 0.62 • n=7 Participants • Two participants were unable to complete test in the allotted time. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.14 z-score
STANDARD_DEVIATION 0.62 • n=9 Participants • Two participants were unable to complete test in the allotted time. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.37 z-score
STANDARD_DEVIATION 0.65 • n=16 Participants • Two participants were unable to complete test in the allotted time. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Trail Making Test, Part B
Completed Trial (Per Protocol)
|
-0.63 z-score
STANDARD_DEVIATION 0.67 • n=6 Participants • Two participants were unable to complete test in the allotted time. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.13 z-score
STANDARD_DEVIATION 0.66 • n=8 Participants • Two participants were unable to complete test in the allotted time. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.34 z-score
STANDARD_DEVIATION 0.69 • n=14 Participants • Two participants were unable to complete test in the allotted time. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Grooved Pegboard Test, Dominant Hand
Enrolled
|
-0.83 z-score
STANDARD_DEVIATION 1.09 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.78 z-score
STANDARD_DEVIATION 0.49 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.80 z-score
STANDARD_DEVIATION 0.81 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Grooved Pegboard Test, Dominant Hand
Completed Trial (ITT)
|
-0.74 z-score
STANDARD_DEVIATION 0.97 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.83 z-score
STANDARD_DEVIATION 0.50 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.79 z-score
STANDARD_DEVIATION 0.72 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Grooved Pegboard Test, Dominant Hand
Completed Trial (Per Protocol)
|
-0.68 z-score
STANDARD_DEVIATION 1.05 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.90 z-score
STANDARD_DEVIATION 0.50 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.81 z-score
STANDARD_DEVIATION 0.75 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Grooved Pegboard Test, Non-Dominant Hand
Enrolled
|
-1.42 z-score
STANDARD_DEVIATION 1.07 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.35 z-score
STANDARD_DEVIATION 1.46 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.86 z-score
STANDARD_DEVIATION 1.37 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Grooved Pegboard Test, Non-Dominant Hand
Completed Trial (ITT)
|
-1.41 z-score
STANDARD_DEVIATION 1.05 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.38 z-score
STANDARD_DEVIATION 1.56 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.83 z-score
STANDARD_DEVIATION 1.42 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Grooved Pegboard Test, Non-Dominant Hand
Completed Trial (Per Protocol)
|
-1.27 z-score
STANDARD_DEVIATION 1.07 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.76 z-score
STANDARD_DEVIATION 1.11 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
-0.98 z-score
STANDARD_DEVIATION 1.08 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
CD4, Absolute Count
Enrolled
|
616.80 cells per cubic mm
STANDARD_DEVIATION 170.18 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
598.55 cells per cubic mm
STANDARD_DEVIATION 290.86 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
607.24 cells per cubic mm
STANDARD_DEVIATION 235.41 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
CD4, Absolute Count
Completed Trial (ITT)
|
538.86 cells per cubic mm
STANDARD_DEVIATION 127.73 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
527.78 cells per cubic mm
STANDARD_DEVIATION 176.30 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
532.63 cells per cubic mm
STANDARD_DEVIATION 152.10 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
CD4, Absolute Count
Completed Trial (Per Protocol)
|
518.17 cells per cubic mm
STANDARD_DEVIATION 126.42 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
514.63 cells per cubic mm
STANDARD_DEVIATION 183.69 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
516.14 cells per cubic mm
STANDARD_DEVIATION 155.95 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
HIV Viral Load, Plasma
Enrolled · Undetectable (<20 copies/mL)
|
5 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
9 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
14 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
HIV Viral Load, Plasma
Enrolled · Low Detectable (20-49 copies/mL)
|
5 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
6 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
HIV Viral Load, Plasma
Enrolled · Low Detectable (50-99 copies/mL)
|
0 Participants
n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
HIV Viral Load, Plasma
Completed Trial (ITT) · Undetectable (<20 copies/mL)
|
3 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
7 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
10 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
HIV Viral Load, Plasma
Completed Trial (ITT) · Low Detectable (20-49 copies/mL)
|
4 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
HIV Viral Load, Plasma
Completed Trial (ITT) · Low Detectable (50-99 copies/mL)
|
0 Participants
n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
HIV Viral Load, Plasma
Completed Trial (Per Protocol) · Undetectable (<20 copies/mL)
|
2 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
6 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
8 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
HIV Viral Load, Plasma
Completed Trial (Per Protocol) · Low Detectable (20-49 copies/mL)
|
4 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
5 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
HIV Viral Load, Plasma
Completed Trial (Per Protocol) · Low Detectable (50-99 copies/mL)
|
0 Participants
n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1 Participants
n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Body Mass Index (BMI)
Enrolled
|
31.33 kg/m^2
STANDARD_DEVIATION 8.38 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
31.45 kg/m^2
STANDARD_DEVIATION 6.83 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
31.40 kg/m^2
STANDARD_DEVIATION 7.41 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Body Mass Index (BMI)
Completed Trial (ITT)
|
31.13 kg/m^2
STANDARD_DEVIATION 9.60 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
30.24 kg/m^2
STANDARD_DEVIATION 5.73 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
30.63 kg/m^2
STANDARD_DEVIATION 7.39 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Body Mass Index (BMI)
Completed Trial (Per Protocol)
|
32.38 kg/m^2
STANDARD_DEVIATION 9.86 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
30.44 kg/m^2
STANDARD_DEVIATION 6.10 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
31.27 kg/m^2
STANDARD_DEVIATION 7.64 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Glucose, Fasting Blood
Enrolled
|
101.50 mg/dL
STANDARD_DEVIATION 11.68 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
93.55 mg/dL
STANDARD_DEVIATION 11.11 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
97.33 mg/dL
STANDARD_DEVIATION 11.82 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Glucose, Fasting Blood
Completed Trial (ITT)
|
101.86 mg/dL
STANDARD_DEVIATION 13.69 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
93.33 mg/dL
STANDARD_DEVIATION 12.35 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
97.06 mg/dL
STANDARD_DEVIATION 13.24 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Glucose, Fasting Blood
Completed Trial (Per Protocol)
|
101.83 mg/dL
STANDARD_DEVIATION 15.00 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
95.63 mg/dL
STANDARD_DEVIATION 10.97 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
98.29 mg/dL
STANDARD_DEVIATION 12.71 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Insulin, Fasting Serum
Enrolled
|
29.38 mcU/mL
STANDARD_DEVIATION 31.93 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
42.66 mcU/mL
STANDARD_DEVIATION 82.28 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
36.34 mcU/mL
STANDARD_DEVIATION 62.37 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Insulin, Fasting Serum
Completed Trial (ITT)
|
25.23 mcU/mL
STANDARD_DEVIATION 38.18 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
19.30 mcU/mL
STANDARD_DEVIATION 17.43 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
21.89 mcU/mL
STANDARD_DEVIATION 27.47 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Insulin, Fasting Serum
Completed Trial (Per Protocol)
|
28.77 mcU/mL
STANDARD_DEVIATION 40.55 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
19.83 mcU/mL
STANDARD_DEVIATION 18.56 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
23.66 mcU/mL
STANDARD_DEVIATION 28.96 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Amylase, Blood
Enrolled
|
89.00 U/L
STANDARD_DEVIATION 30.32 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
78.73 U/L
STANDARD_DEVIATION 27.53 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
83.62 U/L
STANDARD_DEVIATION 28.64 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Amylase, Blood
Completed Trial (ITT)
|
89.14 U/L
STANDARD_DEVIATION 35.43 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
80.11 U/L
STANDARD_DEVIATION 30.51 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
84.06 U/L
STANDARD_DEVIATION 31.93 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Amylase, Blood
Completed Trial (Per Protocol)
|
88.83 U/L
STANDARD_DEVIATION 38.80 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
82.50 U/L
STANDARD_DEVIATION 31.70 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
85.21 U/L
STANDARD_DEVIATION 33.63 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Lipase, Blood
Enrolled
|
25.70 U/L
STANDARD_DEVIATION 9.70 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
28.55 U/L
STANDARD_DEVIATION 12.68 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
27.19 U/L
STANDARD_DEVIATION 11.17 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Lipase, Blood
Completed Trial (ITT)
|
22.14 U/L
STANDARD_DEVIATION 8.53 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
27.44 U/L
STANDARD_DEVIATION 13.90 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
25.13 U/L
STANDARD_DEVIATION 11.81 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Lipase, Blood
Completed Trial (Per Protocol)
|
23.67 U/L
STANDARD_DEVIATION 8.24 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
26.13 U/L
STANDARD_DEVIATION 14.25 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
25.07 U/L
STANDARD_DEVIATION 11.70 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Thyroid Stimulating Hormone
Enrolled
|
1.67 u[IU]/mL
STANDARD_DEVIATION 0.34 • n=10 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1.50 u[IU]/mL
STANDARD_DEVIATION 0.78 • n=11 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1.58 u[IU]/mL
STANDARD_DEVIATION 0.60 • n=21 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Thyroid Stimulating Hormone
Completed Trial (ITT)
|
1.52 u[IU]/mL
STANDARD_DEVIATION 0.19 • n=7 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1.69 u[IU]/mL
STANDARD_DEVIATION 0.73 • n=9 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1.62 u[IU]/mL
STANDARD_DEVIATION 0.55 • n=16 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Thyroid Stimulating Hormone
Completed Trial (Per Protocol)
|
1.50 u[IU]/mL
STANDARD_DEVIATION 0.20 • n=6 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1.72 u[IU]/mL
STANDARD_DEVIATION 0.77 • n=8 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
1.63 u[IU]/mL
STANDARD_DEVIATION 0.59 • n=14 Participants • Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Vitamin B12, Blood
Enrolled
|
390.5 pg/mL
n=10 Participants • Two participants did not have baseline vitamin B12 levels tested. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
448.0 pg/mL
n=9 Participants • Two participants did not have baseline vitamin B12 levels tested. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
442.0 pg/mL
n=19 Participants • Two participants did not have baseline vitamin B12 levels tested. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Vitamin B12, Blood
Completed Trial (ITT)
|
397.0 pg/mL
n=7 Participants • Two participants did not have baseline vitamin B12 levels tested. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
461.0 pg/mL
n=8 Participants • Two participants did not have baseline vitamin B12 levels tested. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
448.0 pg/mL
n=15 Participants • Two participants did not have baseline vitamin B12 levels tested. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
|
Vitamin B12, Blood
Completed Trial (Per Protocol)
|
390.5 pg/mL
n=6 Participants • Two participants did not have baseline vitamin B12 levels tested. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
474.0 pg/mL
n=7 Participants • Two participants did not have baseline vitamin B12 levels tested. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
448.0 pg/mL
n=13 Participants • Two participants did not have baseline vitamin B12 levels tested. Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
|
PRIMARY outcome
Timeframe: Total during 24-week trialPopulation: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
Number of documented serious adverse events per participant, mean
Outcome measures
| Measure |
Insulin, Intranasal
n=10 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=11 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Serious Adverse Event Frequency
Enrolled
|
0.30 Number of SAEs/participant
Standard Deviation 0.67
|
0.18 Number of SAEs/participant
Standard Deviation 0.40
|
|
Serious Adverse Event Frequency
Completed Trial (ITT)
|
0.14 Number of SAEs/participant
Standard Deviation 0.38
|
0.22 Number of SAEs/participant
Standard Deviation 0.44
|
|
Serious Adverse Event Frequency
Completed Trial (Per Protocol)
|
0.00 Number of SAEs/participant
Standard Deviation 0.00
|
0.25 Number of SAEs/participant
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: Total during 24-week trialPopulation: Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
Number participants with at least one documented serious adverse event, count
Outcome measures
| Measure |
Insulin, Intranasal
n=10 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=11 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Serious Adverse Event Frequency, Participant Count
Enrolled
|
2 Participants
|
2 Participants
|
|
Serious Adverse Event Frequency, Participant Count
Completed Trial (ITT)
|
1 Participants
|
2 Participants
|
|
Serious Adverse Event Frequency, Participant Count
Completed Trial (Per Protocol)
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Difference between baseline and week 24 visitsPopulation: Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
Change in GDS, measured at two time points, baseline and Week 24 visits. GDS is a composite score based on neurocognitive test performance. The 14 data points that comprise the GDS include Hopkins Verbal Learning Test (trials 1-3 total score and delayed recall), Rey Complex Figure Test (copy and delayed recall), WAIS symbol-digit test, grooved pegboard (dominant and non-dominant), CalCAP (Choice reaction time and Sequential reaction time), Trail-making Test (Parts A and B), Stroop Color Interference Test (trial 3), timed gait (3 trials average), and verbal fluency (FAS). Raw scores were transformed to t-scores using age/education stratified normative data, then assigned a discrete value from 0 to 5 using the following t-score categorization: \> or = 40 is '0', 35.00 to 39.99 is '1', 30.00 to 34.99 is '2', 25.00 to 29.99 is '3', 20.00 to 24.99 is '4', and \<20 is '5'. The 14 individual scores were then averaged. A higher GDS is a worse outcome (0 = no deficits and 5 = maximum deficits).
Outcome measures
| Measure |
Insulin, Intranasal
n=7 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=9 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score
Completed Trial (Per Protocol)
|
-0.2383 units on a scale
Standard Deviation 0.3529
|
0.2763 units on a scale
Standard Deviation 0.2820
|
|
Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score
Completed Trial (ITT)
|
-0.1614 units on a scale
Standard Deviation 0.3810
|
0.2300 units on a scale
Standard Deviation 0.2981
|
SECONDARY outcome
Timeframe: Difference between baseline and week 24 visitsPopulation: Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks. Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention.
NPZ-8 score at 24 weeks minus baseline NPZ-8 score: The NPZ-8 is an average of 8 individual Z-scores, where higher values indicate greater neurocognitive performance (better outcome). The NPZ-8 represents the number of standard deviations an individual's performance is away from the mean (Z-score = 0) of age and education matched reference populations where performance worse than the mean had negative Z-scores (i.e. Z-scores were inverted for tests scored on speed). The NPZ-8 average is comprised of 8 data points from 6 tests: timed gait, WAIS symbol-digit, grooved pegboard dominant \& non-dominant, CalCAP Choice \& Sequential reaction times, and the Trail-making Test parts A \& B. Raw scores were transformed to Z-scores for each test and then averaged to calculate the NPZ-8 score at each visit (Z-scores +/-3.5 standard deviations from mean limited to +/-3.5). Positive change in NPZ-8 from baseline to Week 24 indicated improved performance and negative change indicated worse performance.
Outcome measures
| Measure |
Insulin, Intranasal
n=7 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=9 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score
Completed Trial (ITT)
|
-0.09 z-score
Standard Deviation 0.39
|
-0.01 z-score
Standard Deviation 0.57
|
|
Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score
Completed Trial (Per Protocol)
|
-0.07 z-score
Standard Deviation 0.42
|
-0.02 z-score
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Between baseline and week 24 visitsPopulation: Baseline and Week 24 CSF samples were collected from only 4 participants. CSF biomarker assays were not performed because the target number of 36 evaluable patients was not reached, and we had insufficient power to detect a true difference in change per the statistical analysis plan.
Changes in cerebrospinal fluid (CSF) concentrations of ceramide, sphingomyelin, citrate, neurofilament protein; brain-derived neurotrophic factor (BDNF), protein carbonyl, Aβ-42
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes between baseline and week 24 visitsPopulation: MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, one had invalid basal ganglia MRS results at Week 24, another is missing all Week 24 MRS results due to technical error in data collection. Available MRS (data for outcome measure): 14 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 11 Pts.
Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in the basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Outcome measures
| Measure |
Insulin, Intranasal
n=6 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=8 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Neuroimaging Markers: SV-MRS, Myoinositol, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Completed Trial (Per Protocol)
|
0.5373 mmol/L, approx. (institutional units)
Standard Deviation 0.8859
|
0.3022 mmol/L, approx. (institutional units)
Standard Deviation 0.7404
|
|
Neuroimaging Markers: SV-MRS, Myoinositol, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Available MRS Secondary Outcomes
|
0.7855 mmol/L, approx. (institutional units)
Standard Deviation 0.8485
|
0.4759 mmol/L, approx. (institutional units)
Standard Deviation 0.8174
|
SECONDARY outcome
Timeframe: Changes between baseline and week 24 visitsPopulation: MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, three Pts had invalid frontal white matter MRS results at either baseline or Week 24, and a fourth is missing all Week 24 MRS results due to technical error in data collection. Available MRS (data for outcome measure): 12 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 9 Pts
Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Outcome measures
| Measure |
Insulin, Intranasal
n=6 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=6 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Neuroimaging Markers: SV-MRS, Myoinositol, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Available MRS Secondary Outcomes
|
0.2617 mmol/L, approx. (institutional units)
Standard Deviation 1.8493
|
0.2155 mmol/L, approx. (institutional units)
Standard Deviation 1.1215
|
|
Neuroimaging Markers: SV-MRS, Myoinositol, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Completed Trial (Per Protocol)
|
0.6063 mmol/L, approx. (institutional units)
Standard Deviation 2.1711
|
0.0382 mmol/L, approx. (institutional units)
Standard Deviation 1.1560
|
SECONDARY outcome
Timeframe: Changes between baseline and week 24 visitsPopulation: MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, one had invalid basal ganglia MRS results at Week 24, another is missing all Week 24 MRS results due to technical error in data collection. Available MRS (data for outcome measure): 14 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 11 Pts
Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Outcome measures
| Measure |
Insulin, Intranasal
n=6 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=8 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Neuroimaging Markers: SV-MRS, Choline, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Available MRS Secondary Outcomes
|
-0.1495 mmol/L, approx. (institutional units)
Standard Deviation 0.3583
|
0.1907 mmol/L, approx. (institutional units)
Standard Deviation 0.4769
|
|
Neuroimaging Markers: SV-MRS, Choline, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Completed Trial (Per Protocol)
|
-0.1905 mmol/L, approx. (institutional units)
Standard Deviation 0.4548
|
0.1162 mmol/L, approx. (institutional units)
Standard Deviation 0.4757
|
SECONDARY outcome
Timeframe: Changes between baseline and week 24 visitsPopulation: MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, three Pts had invalid frontal white matter MRS results at either baseline or Week 24, and a fourth is missing all Week 24 MRS results due to technical error in data collection. Available MRS (data for outcome measure): 12 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 9 Pts
Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Outcome measures
| Measure |
Insulin, Intranasal
n=6 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=6 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Neuroimaging Markers: SV-MRS, Choline, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Available MRS Secondary Outcomes
|
0.1670 mmol/L, approx. (institutional units)
Standard Deviation 0.3430
|
-0.1557 mmol/L, approx. (institutional units)
Standard Deviation 0.2130
|
|
Neuroimaging Markers: SV-MRS, Choline, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Completed Trial (Per Protocol)
|
0.2028 mmol/L, approx. (institutional units)
Standard Deviation 0.4017
|
-0.2128 mmol/L, approx. (institutional units)
Standard Deviation 0.1795
|
SECONDARY outcome
Timeframe: Changes between baseline and week 24 visitsPopulation: MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, one had invalid basal ganglia MRS results at Week 24, another is missing all Week 24 MRS results due to technical error in data collection. Available MRS (data for outcome measure): 14 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 11 Pts
Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Outcome measures
| Measure |
Insulin, Intranasal
n=6 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=8 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Available MRS Secondary Outcomes
|
-0.5572 mmol/L, approx. (institutional units)
Standard Deviation 0.9270
|
-0.1870 mmol/L, approx. (institutional units)
Standard Deviation 0.8497
|
|
Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Completed Trial (Per Protocol)
|
-0.7895 mmol/L, approx. (institutional units)
Standard Deviation 1.1018
|
-0.2915 mmol/L, approx. (institutional units)
Standard Deviation 0.8801
|
SECONDARY outcome
Timeframe: Changes between baseline and week 24 visitsPopulation: MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, three Pts had invalid frontal white matter MRS results at either baseline or Week 24, and a fourth is missing all Week 24 MRS results due to technical error in data collection. Available MRS (data for outcome measure): 12 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 9 Pts
Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Outcome measures
| Measure |
Insulin, Intranasal
n=6 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=6 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Available MRS Secondary Outcomes
|
0.1050 mmol/L, approx. (institutional units)
Standard Deviation 1.7154
|
0.1432 mmol/L, approx. (institutional units)
Standard Deviation 0.6497
|
|
Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Completed Trial (Per Protocol)
|
0.2597 mmol/L, approx. (institutional units)
Standard Deviation 2.1606
|
0.1134 mmol/L, approx. (institutional units)
Standard Deviation 0.7218
|
SECONDARY outcome
Timeframe: Changes between baseline and week 24 visitsPopulation: MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, one is missing all Week 24 DTI results due to technical error in data collection. Available MRS (data for outcome measure): 15 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 12 Pts
Diffusion tensor imaging (DTI), change in whole brain fractional anisotropy (FA) between baseline and 24 weeks. FA is a unitless index that is used for measuring diffusion asymmetry. FA values range from 0 to 1 (0 equals no anisotropy; greater anisotropy is indicated by higher FA values approaching the maximum of 1). FA was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean FA = (Sum of (each ROI's FA \* volume)) / (Sum of all ROI volumes).
Outcome measures
| Measure |
Insulin, Intranasal
n=7 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=8 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Neuroimaging Markers: DTI, Whole Brain Mean Fractional Anisotropy (FA), Week 24 Visit Value Minus Baseline Value
All Available
|
-0.0011885 index
Standard Deviation 0.0055178
|
-0.0043236 index
Standard Deviation 0.0071927
|
|
Neuroimaging Markers: DTI, Whole Brain Mean Fractional Anisotropy (FA), Week 24 Visit Value Minus Baseline Value
Per Protocol
|
-0.0022483 index
Standard Deviation 0.0035673
|
-0.0048070 index
Standard Deviation 0.0076274
|
SECONDARY outcome
Timeframe: Changes between baseline and week 24 visitsPopulation: MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, one is missing all Week 24 DTI results due to technical error in data collection. Available MRS (data for outcome measure): 15 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 12 Pts
Diffusion weighted imaging, change in whole brain mean diffusivity (MD) between baseline and 24 weeks. MD was measured as the mean of three eigenvalues and has the unit m\^2/s. Higher values indicate greater diffusivity. MD was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean MD = (Sum of (each ROI's MD \* volume)) / (Sum of all ROI volumes).
Outcome measures
| Measure |
Insulin, Intranasal
n=7 Participants
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=8 Participants
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Neuroimaging Markers: Diffusion Weighted Imaging, Whole Brain Mean Diffusivity, Week 24 Visit Value Minus Baseline Value
All Available
|
4.7274*10^-6 m^2/s
Standard Deviation 1.9275*10^-5
|
4.1177*10^-6 m^2/s
Standard Deviation 6.2060*10^-5
|
|
Neuroimaging Markers: Diffusion Weighted Imaging, Whole Brain Mean Diffusivity, Week 24 Visit Value Minus Baseline Value
Per Protocol
|
5.8845*10^-6 m^2/s
Standard Deviation 2.2223*10^-5
|
1.1278*10^-5 m^2/s
Standard Deviation 6.3362*10^-5
|
SECONDARY outcome
Timeframe: Changes between baseline and week 24 visitsPopulation: Collected data were not considered valid due to an equipment malfunction.
Arterial spin labeling (ASL), a novel measure of cerebral blood flow
Outcome measures
Outcome data not reported
Adverse Events
Insulin, Intranasal
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo, Intranasal
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin, Intranasal
n=10 participants at risk
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=11 participants at risk
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
Psychiatric disorders
Major depressive episode
|
0.00%
0/10 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
18.2%
2/11 • Number of events 2 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Renal and urinary disorders
Kidney obstruction
|
10.0%
1/10 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
0.00%
0/11 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Cardiac disorders
Cardiac event
|
10.0%
1/10 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
0.00%
0/11 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Vascular disorders
Hospitalization for syncope/hypotension
|
10.0%
1/10 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
0.00%
0/11 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
Other adverse events
| Measure |
Insulin, Intranasal
n=10 participants at risk
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device
|
Placebo, Intranasal
n=11 participants at risk
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device
|
|---|---|---|
|
General disorders
Fall
|
10.0%
1/10 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
18.2%
2/11 • Number of events 2 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • Number of events 3 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
45.5%
5/11 • Number of events 5 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
General disorders
Nosebleed
|
10.0%
1/10 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
18.2%
2/11 • Number of events 2 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Number of events 3 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
9.1%
1/11 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
General disorders
Congestion/Runny Nose
|
40.0%
4/10 • Number of events 4 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
27.3%
3/11 • Number of events 3 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
General disorders
Nasal Irritation or Reaction (during administration of investigational product)
|
70.0%
7/10 • Number of events 7 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
36.4%
4/11 • Number of events 4 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
20.0%
2/10 • Number of events 2 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
45.5%
5/11 • Number of events 5 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Product Issues
Odor/Taste (during administration of investigational product)
|
50.0%
5/10 • Number of events 5 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
9.1%
1/11 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
20.0%
2/10 • Number of events 2 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
9.1%
1/11 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
27.3%
3/11 • Number of events 3 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Pain or Discomfort
|
20.0%
2/10 • Number of events 2 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
0.00%
0/11 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Infections and infestations
Infection (other than upper respiratory infection)
|
20.0%
2/10 • Number of events 2 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
0.00%
0/11 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Renal and urinary disorders
Creatinine, High Blood
|
20.0%
2/10 • Number of events 2 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
18.2%
2/11 • Number of events 2 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
General disorders
Nausea
|
30.0%
3/10 • Number of events 3 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
0.00%
0/11 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
General disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
0.00%
0/11 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
General disorders
Blood Pressure, High (acute)
|
0.00%
0/10 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
9.1%
1/11 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
General disorders
Edema, Lower Extremity
|
0.00%
0/10 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
9.1%
1/11 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Endocrine disorders
Glucose, High Blood
|
10.0%
1/10 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
0.00%
0/11 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
|
Endocrine disorders
Amylase, High Blood
|
10.0%
1/10 • Number of events 1 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
0.00%
0/11 • AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.
|
Additional Information
Dr. Leah Rubin, Associate Professor of Neurology, Psychiatry, and Epidemiology
Johns Hopkins University
Phone: 410-955-7311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place