Alzheimer's Prevention Through Exercise

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise Group	Aerobic Exercise	Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Control Group	Standard of Care	Standard of Care exercise recommendations

Primary Outcome Measures

Name	Time	Method
Amyloid Burden	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.

Secondary Outcome Measures

Name	Time	Method
Executive Function	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.
Whole Brain Volume	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.