Trial Outcomes & Findings for Alzheimer's Prevention Through Exercise (NCT NCT02000583)
NCT ID: NCT02000583
Last Updated: 2020-07-28
Results Overview
Amyloid burden measure is mean Florbetapir cortical-to-cerebellar uptake ratio averaged across 6 regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus). Higher numbers mean more amyloid accumulation. There is no defined maximum value. Zero is the theoretical minimum value.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
Baseline to 52 weeks
Results posted on
2020-07-28
Participant Flow
Participant milestones
| Measure |
Aerobic Exercise Group
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
|
Control Group
Standard of Care exercise recommendations
Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
39
|
|
Overall Study
COMPLETED
|
75
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alzheimer's Prevention Through Exercise
Baseline characteristics by cohort
| Measure |
Aerobic Exercise Group
n=78 Participants
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
|
Control Group
n=39 Participants
Standard of Care exercise recommendations
Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
78 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 5.3 • n=99 Participants
|
71.2 years
STANDARD_DEVIATION 4.8 • n=107 Participants
|
71.5 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=99 Participants
|
39 participants
n=107 Participants
|
117 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksPopulation: Six individuals did not complete follow-up testing due to withdrawal. Two refused follow-up PET.
Amyloid burden measure is mean Florbetapir cortical-to-cerebellar uptake ratio averaged across 6 regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus). Higher numbers mean more amyloid accumulation. There is no defined maximum value. Zero is the theoretical minimum value.
Outcome measures
| Measure |
Aerobic Exercise Group
n=74 Participants
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
|
Control Group
n=35 Participants
Standard of Care exercise recommendations
Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
|
|---|---|---|
|
Amyloid Burden
Baseline
|
1.20 Standard Uptake Value Ratio (SUVR)
Standard Deviation .2
|
1.22 Standard Uptake Value Ratio (SUVR)
Standard Deviation .2
|
|
Amyloid Burden
Follow-up
|
1.21 Standard Uptake Value Ratio (SUVR)
Standard Deviation .2
|
1.22 Standard Uptake Value Ratio (SUVR)
Standard Deviation .2
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: Six individuals did not complete follow-up testing due to withdrawal. Seven refused follow-up MRI.
Whole brain volume in mL define by Freesurfer analysis. Higher numbers indicate greater brain volume. There is no defined maximum. Zero is the theoretical minimum.
Outcome measures
| Measure |
Aerobic Exercise Group
n=70 Participants
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
|
Control Group
n=34 Participants
Standard of Care exercise recommendations
Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
|
|---|---|---|
|
Whole Brain Volume
Baseline
|
1068.7 mL
Standard Deviation 109.7
|
1061.7 mL
Standard Deviation 114.4
|
|
Whole Brain Volume
Follow-up
|
1063.4 mL
Standard Deviation 109.1
|
1059.1 mL
Standard Deviation 115.1
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Six individuals did not complete follow-up testing due to withdrawal.
Executive Function ability to be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests. Values are standard deviations centered on a pooled baseline (all participant scores at baseline). Higher values mean improvement over baseline testing. Lower scores (including negative) mean worse performance after baseline testing. There is no minimum or maximum score.
Outcome measures
| Measure |
Aerobic Exercise Group
n=75 Participants
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
|
Control Group
n=36 Participants
Standard of Care exercise recommendations
Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
|
|---|---|---|
|
Executive Function
Week 26
|
0.017 Standard Deviations
Standard Deviation 0.63
|
-0.035 Standard Deviations
Standard Deviation 0.39
|
|
Executive Function
Follow-up
|
.018 Standard Deviations
Standard Deviation .62
|
-0.037 Standard Deviations
Standard Deviation 0.45
|
|
Executive Function
Baseline
|
0.029 Standard Deviations
Standard Deviation .46
|
-0.042 Standard Deviations
Standard Deviation .37
|
Adverse Events
Aerobic Exercise Group
Serious events: 8 serious events
Other events: 23 other events
Deaths: 0 deaths
Control Group
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aerobic Exercise Group
n=78 participants at risk
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
|
Control Group
n=39 participants at risk
Standard of Care exercise recommendations
Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
|
|---|---|---|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/78 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
2.6%
1/39 • Number of events 1 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
|
Infections and infestations
Infection with unknown ANC
|
5.1%
4/78 • Number of events 4 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
2.6%
1/39 • Number of events 1 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
|
Musculoskeletal and connective tissue disorders
Lower extremity arthroplasty
|
1.3%
1/78 • Number of events 1 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
2.6%
1/39 • Number of events 1 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
|
Hepatobiliary disorders
Hepatobiliary inflammation
|
1.3%
1/78 • Number of events 1 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
0.00%
0/39 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
1.3%
1/78 • Number of events 1 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
0.00%
0/39 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
|
Renal and urinary disorders
Acute Pyelonephritis with urinary tract infection
|
0.00%
0/78 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
2.6%
1/39 • Number of events 1 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
|
Injury, poisoning and procedural complications
Fall and hip fracture requiring fixation
|
1.3%
1/78 • Number of events 1 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
0.00%
0/39 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
Other adverse events
| Measure |
Aerobic Exercise Group
n=78 participants at risk
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
|
Control Group
n=39 participants at risk
Standard of Care exercise recommendations
Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
29.5%
23/78 • Number of events 23 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
10.3%
4/39 • Number of events 4 • One year
Adverse events were defined and graded according to CTCAE 3.0
|
Additional Information
Jeffrey M. Burns MD
University of Kansas Medical Center
Phone: 913-588-0555
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place