Exercise for Brain Health in the Fight Against Alzheimer's Disease

Study Overview
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Brief Summary
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The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80). Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD). Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC). The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus. The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers.

Official Title
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Exercise for Brain Health in the Fight Against Alzheimer's Disease

Conditions
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Healthy Cognition

Intervention / Treatment
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* Other: Exercise Training
* Other: Flexibility Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 to 80 years old Fluent in English Willingness to make the time commitment to participate in the project, including randomization to treatments Physically inactive (physical activity not more than 2 days per week for the past 6 months) Physician consent to undergo an exercise stress test and engage in moderate intensity exercise Determined to be safe for MRI Exclusion Criteria: Neurological illnesses/conditions such as cerebral palsy, epi¬lepsy, brain tumor, chronic meningitis, multiple scle¬rosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease Untreated hypertension, glaucoma, and chronic obstructive pul¬monary disease Untreated severe major depression Substance abuse or dependence Current use of psychoactive medications, except selective serotonin/norepinephrine reuptake inhibitor antidepressants Use of acetylcholinesterase inhibitors (e.g., Aricept) Unstable or severe cardiovascular disease or asthmatic condition History of transient ischemic attack, cerebral ischemia, or clinically diagnosed stroke Diagnosis of mild cognitive impairment or dementia, or objective evidence of cognitive impairment

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Training<br>Group exercise and treadmill walking | Other: Exercise Training<br>* Supervised exercise conducted four days per week for six months.<br>|
| Active Comparator: Flexibility Control<br>Group exercise and flexibility exercise | Other: Flexibility Control<br>* Supervised exercise conducted four days per week for six months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5 |  | Baseline and 6 months | 
| Change from Baseline to 6 months in Resting Cerebral Blood Flow |  | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to 6 months in VO2peak | Estimated peak rate of oxygen consumption, a measure of cardiorespiratory fitness | Baseline and 6 months | 
| Change from Baseline to 6 months in 6 Minute Walk Test | Distance walked in 6 minutes | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking Exercise, Flexibility Exercise, Cognition, Memory, Magnetic Resonance Imaging