Alzheimer's Prevention Through Exercise

Study Overview
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Brief Summary
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The purpose of this study is to learn about the possible benefits of aerobic exercise in controlling or reducing the amount of amyloid present in the brain, reducing changes in brain structure that may lead to Alzheimer's Disease (AD), and increasing cognitive ability in individuals that have amyloid deposits and are at risk to develop AD.

Official Title
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Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Other: Aerobic Exercise
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Exercise Group<br>Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks | Other: Aerobic Exercise<br>* Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks<br>|
| Other: Control Group<br>Standard of Care exercise recommendations | Other: Standard of Care<br>* Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.<br>* Other names: Standard of Care for exercise recommendations;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amyloid Burden | 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. | Baseline to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole Brain Volume | 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. | Baseline to 52 weeks | 
| Executive Function | 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. | Baseline to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, AD, Aerobic Exercise, Exercise