Genes, Exercise, Memory and Neurodegeneration

Not Applicable

Completed

• Conditions: Alzheimer's Disease
• Interventions: Behavioral: aerobic exercise-training; Behavioral: stretch exercise

• Registration Number: NCT01021644
• Lead Sponsor: Howard University

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-30
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-13
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aerobic exercise-training	aerobic exercise-training	-
stretch exercise	stretch exercise	-

Primary Outcome Measures

Name	Time	Method
AD Assessment Scale-Cognitive (ADAS-COG)	baseline, 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory Q (NPIQ)	baseline and 6 months
Geriatric Depression Scale	baseline and 6 months
Logical Memory Test (Delayed Paragraph Recall)	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
Mini-Mental State Exam (MMSE)	baseline, 3 and 6 months
CDR (Clinical Dementia Rating) Scale	baseline, 3 and 6 months
Visuospatial and Visuographic: Clock Drawing Test	baseline and 6 months
American National Adult Reading Test (ANART)	baseline and 6 months

Trial Locations

Locations (2)

Howard University General Clinical Research Center (GCRC); 🇺🇸 Washington, District of Columbia, United States

Temple University Exercise Physiology Laboratory; 🇺🇸 Philadelphia, Pennsylvania, United States