Genes, Exercise, Memory and Neurodegeneration

Study Overview
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Brief Summary
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The primary purpose of this pilot study is to determine whether African Americans with mild Alzheimer's disease (AD) can be enrolled and retained in a 6-month aerobic exercise-training study.

Detailed Description
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This study will examine the effects of aerobic exercise-training on neurocognitive function, and on cerebral glucose homeostasis. It is yet to be determined whether African Americans with mild AD can be recruited into such a study, nor has the relationship of fitness adaptation to neurocognitive function been systematically examined in this population. In addition to the goal of assessing the intervention effects, the study will evaluate the differential relationships of APOE to aerobic fitness-induced changes in neurocognition. The long-term goal is to explore the mechanism by which fitness adaptation exerts an effect on neurocognition, notably, low levels of high-density lipoprotein cholesterol (HDL-C), elevated inflammation (C-reactive protein (CRP) and interleukins (IL-1A)), deranged glucose homeostasis, hypertension and endothelia dysfunction are precursors of arteriolosclerosis, decreased cerebral perfusion and oxygen deprivation, all of which may increase AD risk. Because many of these putative AD risk factors are susceptible to lifestyle alterations, the study will also assess their roles in aerobic fitness-related improvements in cognitive function and reduction in AD risk.

Official Title
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Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Behavioral: aerobic exercise-training
* Behavioral: stretch exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 60 years Ability to exercise vigorously without harm Mild AD Study partner In good general health Willing to exercise for 6 months Body Mass Index (BMI) less than 37 Women participants must be postmenopausal for at least 2 years, and maintain current hormone replacement therapy status and allowed medication usage for the duration of the study Exclusion Criteria: MMSE score below 20 TG (Triglyceride) greater than 400 mg/dl LDL-C levels greater than 95% or HDL-C levels less than 10% of age and sex-adjusted norms

Ages Eligible for Study
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Minimum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aerobic exercise-training<br> | Behavioral: aerobic exercise-training<br>* 3 times per week for 6 months<br>|
| Active Comparator: stretch exercise<br> | Behavioral: stretch exercise<br>* 3 times per week for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AD Assessment Scale-Cognitive (ADAS-COG) |  | baseline, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Exam (MMSE) |  | baseline, 3 and 6 months | 
| CDR (Clinical Dementia Rating) Scale |  | baseline, 3 and 6 months | 
| Logical Memory Test (Delayed Paragraph Recall) |  | baseline and 6 months | 
| Visuospatial and Visuographic: Clock Drawing Test |  | baseline and 6 months | 
| American National Adult Reading Test (ANART) |  | baseline and 6 months | 
| Neuropsychiatric Inventory Q (NPIQ) |  | baseline and 6 months | 
| Geriatric Depression Scale |  | baseline and 6 months | 
| Activities of Daily Living (ADCS-ADL) |  | baseline and 6 months | 
| PET imaging to measure cerebral glucose homeostasis/metabolism |  | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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APOE, Apolipoprotein E, Cognition Disorders, Neurocognition