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
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|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.
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|Ages Eligible for Study:||65 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Clinical Dementia Rating 0 (nondemented)
- Age 65 or older
- Florbetapir PET evidence of cerebral amyloidosis
- Sedentary or underactive by the Telephone Assessment of Physical Activity
- Stable doses of medications for 30 days.
- Clinician judgment regarding subject's health status and likelihood to successfully complete the 1-year exercise intervention
- Clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to standard criteria or significant psychiatric symptoms that could impair the completion of the study
- Clinically-significant systemic illness that may affect safety or completion of the study
- History of clinically-evident stroke
- Clinically-significant infection within the last 30 days
- Active cardiac condition (e.g. angina, myocardial infarction, atrial fibrillation) or pulmonary condition in the past 2 years that, in the investigator's opinion, could pose a safety risk to the participant-unless cleared for exercise by the participant's primary care physician or cardiologist.
- Uncontrolled hypertension within the last 6 months
- History of cancer in the last 5 years (except non-metastatic basal or squamous cell carcinoma)
- History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
- Insulin-dependent diabetes mellitus
- Significant pain or musculoskeletal disorder prohibiting participation in an exercise program
- Unwillingness to undergo or contraindication to brain MRI scan.
- History within the last 5 years of primary or recurrent malignant disease with the exception of resected localized cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma, or prostate cancer.
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|
Documents provided by University of Kansas Medical Center:
|Responsible Party:||University of Kansas Medical Center|
|Other Study ID Numbers:||
R01AG043962-01 ( U.S. NIH Grant/Contract )
|First Posted:||December 4, 2013 Key Record Dates|
|Results First Posted:||July 28, 2020|
|Last Update Posted:||July 28, 2020|
|Last Verified:||July 2020|
Central Nervous System Diseases
Nervous System Diseases