Trial Outcomes & Findings for SNIFF - Combo INI+EMPA Trial (NCT NCT05081219)
NCT ID: NCT05081219
Last Updated: 2025-10-21
Results Overview
Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE v5.0). The number of participants with grade 3 or greater adverse events that were deemed to be possibly, probably, or definitely related to study treatment will be reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Week 8
Results posted on
2025-10-21
Participant Flow
Participant milestones
| Measure |
Intranasal Insulin and Empagliflozin Placebo
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
12
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Intranasal Insulin and Empagliflozin Placebo
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
0
|
1
|
Baseline Characteristics
SNIFF - Combo INI+EMPA Trial
Baseline characteristics by cohort
| Measure |
Intranasal Insulin and Empagliflozin Placebo
n=14 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
n=12 Participants
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
n=11 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
n=10 Participants
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 4.6 • n=99 Participants
|
67.4 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
71.2 years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
71.7 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
70.3 years
STANDARD_DEVIATION 6.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: One participant in Insulin/Empagliflozin Placebo arm withdrew before starting study drug
Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE v5.0). The number of participants with grade 3 or greater adverse events that were deemed to be possibly, probably, or definitely related to study treatment will be reported.
Outcome measures
| Measure |
Intranasal Insulin and Empagliflozin Placebo
n=13 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
n=12 Participants
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
n=11 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
n=10 Participants
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Related Serious Adverse Events as Assessed by CTCAE v5.0
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Insulin/Empagliflozin Placebo Arm: 1 participant in withdrew prior to receiving study drug, 3 participants did not complete study, 1 participant did not have data for this outcome. Placebo Arm: one participant did not complete study, 1 participant did not have data for this outcome.
Cognition will be measured using the Preclinical Alzheimer Cognitive Composite V5 (PACC5) scale, which includes the free/cued selective reminding test, delayed paragraph recall, digit-symbol substitution, mini mental state score, and the category fluency task. The PACC5 is a composite score comprised of measures of global cognition, memory, and executive function. A z-score of 0 equals the mean for the baseline PACC5 score for all analyzed participants. Higher (more positive) z-scores mean greater improvement in the cognition test over time. There are no clinically relevant thresholds as this is a cognitive variable.
Outcome measures
| Measure |
Intranasal Insulin and Empagliflozin Placebo
n=9 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
n=12 Participants
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
n=11 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
n=8 Participants
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
Change in the Preclinical Alzheimer Cognitive Composite V5 (PACC5) Z-Score
|
0.2 z-score
Standard Deviation 0.1
|
0.0 z-score
Standard Deviation 0.2
|
0.2 z-score
Standard Deviation 0.2
|
-0.1 z-score
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Insulin/Empagliflozin Placebo Arm: 1 participant in withdrew prior to receiving study drug, 3 participants did not complete study, 1 participant did not have data for this outcome. Placebo Arm: one participant did not complete study, 1 participant did not have data for this outcome.
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates more impairment. Scores from the original portion of the test range from 0 (best) to 65 (worse), and are added to the mean of the words not immediately recalled (max of 10) and the number of items not recalled after a delay (ranging from 0-10) all total the maximum score of 90. A positive change indicates cognitive worsening.
Outcome measures
| Measure |
Intranasal Insulin and Empagliflozin Placebo
n=9 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
n=12 Participants
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
n=11 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
n=8 Participants
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
Change in the 14-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score
|
-0.5 score on a scale
Standard Deviation 4.0
|
1.0 score on a scale
Standard Deviation 3.5
|
2.0 score on a scale
Standard Deviation 4.0
|
1.2 score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Insulin/Empagliflozin Placebo Arm: 1 participant withdraw before starting study drug, 3 participants did not finish the study. Insulin/Empagliflozin Arm: 3 participants did not complete the post-treatment lumbar puncture. Placebo Arm: 1 participant did not finish the study.
Cerebrospinal fluid (CSF) samples will be used to measure the levels of amyloid β-peptide (Aβ) 40. CSF Aβ40 is a key Alzheimer's disease (AD) biomarker that reflects pathological aggregation of amyloid in the brain.
Outcome measures
| Measure |
Intranasal Insulin and Empagliflozin Placebo
n=10 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
n=12 Participants
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
n=8 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
n=9 Participants
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
Change in Amyloid β-peptide (Aβ) 40 (Aβ40) in Cerebrospinal Fluid (CSF)
|
10.6 pg/ml
Standard Deviation 1667.4
|
-417.2 pg/ml
Standard Deviation 822.8
|
-159.6 pg/ml
Standard Deviation 396.8
|
-223.6 pg/ml
Standard Deviation 1025.3
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Insulin/Empagliflozin Placebo Arm: 1 participant withdraw before starting study drug, 3 participants did not finish the study. Insulin/Empagliflozin Arm: 3 participants did not complete the post-treatment lumbar puncture. Placebo Arm: 1 participant did not finish the study.
Cerebrospinal fluid (CSF) samples will be used to measure the levels of amyloid β-peptide (Aβ) 42. CSF Aβ42 is a key Alzheimer's disease (AD) biomarker that reflects pathological aggregation of amyloid in the brain.
Outcome measures
| Measure |
Intranasal Insulin and Empagliflozin Placebo
n=10 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
n=12 Participants
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
n=8 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
n=9 Participants
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
Change in Amyloid β-peptide (Aβ) 42 (Aβ42) in Cerebrospinal Fluid (CSF)
|
-29.9 pg/ml
Standard Deviation 169.6
|
-40.6 pg/ml
Standard Deviation 97.0
|
-26.6 pg/ml
Standard Deviation 43.0
|
-5.1 pg/ml
Standard Deviation 102.4
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Insulin/Empagliflozin Placebo Arm: 1 participant withdraw before starting study drug, 3 participants did not finish the study. Insulin/Empagliflozin Arm: 3 participants did not complete the post-treatment lumbar puncture. Placebo Arm: 1 participant did not finish the study.
Cerebrospinal fluid (CSF) samples will be used to measure the levels of total tau protein in the brain to assess impact on brain tau as a relevant Alzheimer's Disease (AD) biomarker.
Outcome measures
| Measure |
Intranasal Insulin and Empagliflozin Placebo
n=10 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
n=12 Participants
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
n=8 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
n=9 Participants
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
Change in Cerebrospinal Fluid (CSF) Levels of Total Tau
|
2.6 pg/ml
Standard Deviation 52.3
|
-20.1 pg/ml
Standard Deviation 36.4
|
-2.6 pg/ml
Standard Deviation 24.4
|
7.7 pg/ml
Standard Deviation 33.6
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Insulin/Empagliflozin Placebo Arm: 1 participant withdraw before starting study drug, 3 participants did not finish the study. Insulin/Empagliflozin Arm: 3 participants did not complete the post-treatment lumbar puncture. Placebo Arm: 1 participant did not finish the study.
Cerebrospinal fluid (CSF) samples will be used to measure the levels of phospho-tau 181 protein in the brain to assess impact on brain tau as a relevant Alzheimer's Disease (AD) biomarker.
Outcome measures
| Measure |
Intranasal Insulin and Empagliflozin Placebo
n=10 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
n=12 Participants
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
n=8 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
n=9 Participants
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 181
|
1.0 pg/ml
Standard Deviation 7.1
|
-1.9 pg/ml
Standard Deviation 3.8
|
0.3 pg/ml
Standard Deviation 5.5
|
0.5 pg/ml
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Insulin/Empagliflozin Placebo Arm: 1 participant withdraw before starting study drug, 3 participants did not finish the study, 1 participant missing data for this outcome. Empagliflozin/ Insulin Placebo Arm: 1 participant missing data for this outcome. Insulin/Empagliflozin Arm: 1 participant missing data for this outcome. Placebo Arm: 1 participant did not finish the study, 1 participant missing data for this outcome.
Change in CBF in mL/100g/min, calculated as the difference between the pre- and post ASL flow in response to the study intervention.
Outcome measures
| Measure |
Intranasal Insulin and Empagliflozin Placebo
n=9 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
n=11 Participants
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
n=10 Participants
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
n=8 Participants
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
Change in Total Cerebral Blood Flow (CBF) Using MRI Pseudocontinuous Arterial Spin Labeling (ASL)
|
-0.4 mL/100g/min
Standard Deviation 5.4
|
-1.8 mL/100g/min
Standard Deviation 5.4
|
-0.5 mL/100g/min
Standard Deviation 2.8
|
3.9 mL/100g/min
Standard Deviation 4.5
|
Adverse Events
Intranasal Insulin and Empagliflozin Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Empagliflozin and Intranasal Insulin Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Intranasal Insulin and Empagliflozin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Insulin and Empagliflozin Placebo
n=14 participants at risk
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
Empagliflozin and Intranasal Insulin Placebo
n=12 participants at risk
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
|
Intranasal Insulin and Empagliflozin
n=11 participants at risk
* 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
|
Placebo
n=10 participants at risk
* 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
* Placebo capsules taken by mouth 30 minutes before breakfast once daily
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
|
|---|---|---|---|---|
|
General disorders
headache
|
14.3%
2/14 • Number of events 3 • baseline through week 8
|
16.7%
2/12 • Number of events 2 • baseline through week 8
|
9.1%
1/11 • Number of events 1 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
Gastrointestinal disorders
nausea/vomiting
|
7.1%
1/14 • Number of events 1 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
18.2%
2/11 • Number of events 3 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
Gastrointestinal disorders
diarrhea
|
7.1%
1/14 • Number of events 1 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
9.1%
1/11 • Number of events 1 • baseline through week 8
|
10.0%
1/10 • Number of events 2 • baseline through week 8
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
10.0%
1/10 • Number of events 1 • baseline through week 8
|
|
Gastrointestinal disorders
abdominal hernia
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
General disorders
head congestion
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
10.0%
1/10 • Number of events 1 • baseline through week 8
|
|
General disorders
back pain after lumbar puncture
|
35.7%
5/14 • Number of events 5 • baseline through week 8
|
25.0%
3/12 • Number of events 3 • baseline through week 8
|
18.2%
2/11 • Number of events 2 • baseline through week 8
|
10.0%
1/10 • Number of events 2 • baseline through week 8
|
|
General disorders
dizziness
|
7.1%
1/14 • Number of events 1 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
18.2%
2/11 • Number of events 2 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
Eye disorders
chronic retinal detachment
|
0.00%
0/14 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
10.0%
1/10 • Number of events 1 • baseline through week 8
|
|
General disorders
toothache/extraction
|
7.1%
1/14 • Number of events 1 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
9.1%
1/11 • Number of events 1 • baseline through week 8
|
10.0%
1/10 • Number of events 2 • baseline through week 8
|
|
General disorders
hot flashes
|
0.00%
0/14 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
10.0%
1/10 • Number of events 1 • baseline through week 8
|
|
General disorders
pain at glucose monitor site
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
General disorders
fall
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
General disorders
confusion
|
0.00%
0/14 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
10.0%
1/10 • Number of events 1 • baseline through week 8
|
|
General disorders
nerve pain during lumbar puncture
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
General disorders
musculoskeletal pain
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
9.1%
1/11 • Number of events 1 • baseline through week 8
|
10.0%
1/10 • Number of events 1 • baseline through week 8
|
|
General disorders
increased urination
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
General disorders
increased appetite
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
General disorders
nasal stinging
|
14.3%
2/14 • Number of events 2 • baseline through week 8
|
16.7%
2/12 • Number of events 2 • baseline through week 8
|
9.1%
1/11 • Number of events 1 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
Infections and infestations
vaginal yeast infection
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 2 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
20.0%
2/10 • Number of events 2 • baseline through week 8
|
|
General disorders
hoarseness/sore throat
|
7.1%
1/14 • Number of events 1 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
General disorders
hypotension
|
0.00%
0/14 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
9.1%
1/11 • Number of events 1 • baseline through week 8
|
10.0%
1/10 • Number of events 1 • baseline through week 8
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/14 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
9.1%
1/11 • Number of events 1 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
General disorders
syncopal episode during lumbar puncture
|
7.1%
1/14 • Number of events 1 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
9.1%
1/11 • Number of events 1 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
Ear and labyrinth disorders
tinnitus
|
7.1%
1/14 • Number of events 1 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
|
General disorders
lethargy
|
7.1%
1/14 • Number of events 1 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
10.0%
1/10 • Number of events 1 • baseline through week 8
|
|
Infections and infestations
COVID19
|
0.00%
0/14 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
10.0%
1/10 • Number of events 1 • baseline through week 8
|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/14 • baseline through week 8
|
0.00%
0/12 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
10.0%
1/10 • Number of events 1 • baseline through week 8
|
|
General disorders
plantar fasciitis surgery
|
0.00%
0/14 • baseline through week 8
|
8.3%
1/12 • Number of events 1 • baseline through week 8
|
0.00%
0/11 • baseline through week 8
|
0.00%
0/10 • baseline through week 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place