Genes, Exercise, Memory, and Neurodegeneration
Genes, Exercise, Memory, and Neurodegeneration
Overall Status:
Recruiting
Brief Description:
The primary purpose of this pilot study is to determine whether African Americans with mild Alzheimer's disease can be enrolled and retained in a 6-month aerobic exercise-training study.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
60 Years | N/A | Both | No |
Inclusion Criteria:
- Age over 60 years
- Ability to exercise vigorously without causing harm to self
- Mild Alzheimer's disease
- Study partner
- 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; 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
Detailed Description:
Although anticholinesterase therapies have greatly improved symptomatic treatment of Alzheimer's disease, they have not been demonstrated to significantly slow disease progression. Preservation of intellectual dexterity among those showing earliest symptoms of Alzheimer's may ameliorate the burden associated with the disease. An evidence-based lifestyle approach is emerging as an alternative or adjunct to anticholinesterase therapy. Specifically, aerobic exercise training has been demonstrated to improve cognitive function.
The mechanism by which an effect occurs is yet to be systematically substantiated. Aerobic fitness can improve many of the putative Alzheimer's disease risk factors, such as high-density lipoprotein cholesterol, inflammation, and arteriolosclerosis. However, improvements in these putative risk factors have not been explored as potential mechanisms by which aerobic training improves cognitive function in humans.
Given that African Americans have higher incidence and prevalence of Alzheimer's disease and are more sedentary relative to Caucasians, a randomized controlled trial of exercise and cognition in older African Americans is imperative.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 38.9178427, -77.0218255 | Howard University General Clinical Research Center | Washington | District of Columbia | 20060 | Recruiting | |
Geolocation is 40.012545, -75.1487007 | Temple University Exercise Physiology Laboratory | Philadelphia | Pennsylvania | 19140 | Recruiting | Michael Brown 215-204-5218 |
Lead Sponsor:
| Agency |
|---|
National Institute on Aging (NIA) |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Thomas O. Obisesan, MD, MPH | Principal Investigator | Howard University |
Study Contact:
| Name | Phone | |
|---|---|---|
Thomas O. Obisesan, MD, MPH | 202-865-3776 |
Locations
ClinicalTrials.gov ID
NCT01021644 (follow link to view full record on ct.gov in new window)
Official Title:
Effects of Standardized Aerobic Exercise Training on Neurocognitive and Neurodegeneration
Study Start Date:
October 2009
Study End Date:
August 2011
Disease Stage:
Early
Enrollment:
112
Trial References:
