Alzheimer's Prevention Through Exercise (APEx)
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|ClinicalTrials.gov Identifier: NCT02000583|
Recruitment Status : Completed
First Posted : December 4, 2013
Results First Posted : July 28, 2020
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Other: Aerobic Exercise Other: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer's Disease|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Experimental: Aerobic Exercise Group
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Other: Aerobic Exercise
Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
Standard of Care exercise recommendations
Other: 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.
Other Name: Standard of Care for exercise recommendations
- Amyloid Burden [ Time Frame: Baseline to 52 weeks ]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.
- Whole Brain Volume [ Time Frame: Baseline to 52 weeks ]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.
- Executive Function [ Time Frame: Baseline to Week 52 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000583
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Jeffrey Burns, MD||University of Kansas Medical Center|