Genes, Exercise, Memory and Neurodegeneration
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Behavioral: aerobic exercise-training Behavioral: stretch exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration |
- AD Assessment Scale-Cognitive (ADAS-COG) [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
- Mini-Mental State Exam (MMSE) [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
- CDR (Clinical Dementia Rating) Scale [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
- Logical Memory Test (Delayed Paragraph Recall) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- Visuospatial and Visuographic: Clock Drawing Test [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- American National Adult Reading Test (ANART) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- Neuropsychiatric Inventory Q (NPIQ) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- Geriatric Depression Scale [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- Activities of Daily Living (ADCS-ADL) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- PET imaging to measure cerebral glucose homeostasis/metabolism [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 112 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: aerobic exercise-training |
Behavioral: aerobic exercise-training
3 times per week for 6 months
|
| Active Comparator: stretch exercise |
Behavioral: stretch exercise
3 times per week for 6 months
|
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Thomas O. Obisesan, MD, MPH | 202-865-3776 | Tobisesan@howard.edu |
| United States, District of Columbia | |
| Howard University General Clinical Research Center (GCRC) | Recruiting |
| Washington, District of Columbia, United States, 20060 | |
| Contact 202-865-1973 | |
| Principal Investigator: Thomas O. Obisesan, MD, MPH | |
| United States, Pennsylvania | |
| Temple University Exercise Physiology Laboratory | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact 215-204-5218 | |
| Principal Investigator: Michael Brown, PhD | |
| Principal Investigator: | Thomas O. Obisesan, MD, MPH | Howard University |
More Information
Publications:
| Responsible Party: | Thomas O. Obisesan, MD, MPH, Howard University Hospital |
| ClinicalTrials.gov Identifier: | NCT01021644 History of Changes |
| Other Study ID Numbers: | IA0172, 1R01AG031517-01A209 |
| Study First Received: | November 25, 2009 |
| Last Updated: | January 24, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Aging (NIA):
|
APOE Apolipoprotein E Cognition Disorders Neurocognition |
Additional relevant MeSH terms:
|
Alzheimer Disease Nerve Degeneration Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013