Start:
May 2010
End:
April 2015
Enrollment:
80
What Is This Study About?
This study will examine the relationship between exercise, brain aging, and Alzheimer's disease in people with early-stage Alzheimer's. It will gather data to help design a larger, multi-site trial that evaluates aerobic exercise as a possible therapy for the disease.
Do I Qualify To Participate in This Study?
Must have:
- Diagnosis of probable Alzheimer's disease (Clinical Dementia Rating of 0.5 or 1; Mini Mental Status Exam Score of 16 to 30; Rosen Modified Hachinski score of 4 or less)
- Community dwelling, with a caregiver able and willing to accompany the participant on all visits, if necessary; the caregiver must visit with the subject more than five times a week for the duration of the study
- Underactive or sedentary as determined by a Telephone Assessment of Physical Activity
- Adequate seeing and hearing ability to perform all cognitive and functional assessments
- Stable doses of medications for at least 30 days prior to screening are allowed; cholinesterase inhibitors and memantine are allowed, provided the participant is on stable doses without clinically significant side effects for 60 days; participant and caregiver agree to continue the same regimen for the trial duration
Must NOT have:
- CDR of 0.5 with uncertain cause of dementia
- Significant neurological disease, other than Alzheimer's disease, that may affect cognition
- MRI or CT scan indicative of significant abnormalities that may explain cognitive decline (for example, multiple lacunar infarcts or a single prior infarct more than 1 cubic cm, micro-hemorrhages or evidence of a prior hemorrhage more than 1 cubic cm, evidence of cerebral contusion, encephalomalacia, aneurysm, vascular malformation, or space-occupying lesion such as a brain tumor)
- Clinically significant major psychiatric disorder such as major depression or significant psychiatric symptoms such as hallucinations that could impair completion of the study
- Clinically significant systemic illness that is likely to result in deterioration of the participant's condition or affect his/her safety during the study
- History of clinically evident stroke
- Clinically significant infection within the last 30 days
- Myocardial infarction or symptoms of coronary artery disease (such as angina) in the last 2 years
- Uncontrolled hypertension within the last 6 months
- History of cancer within the last 5 years (except nonmetastatic basal or squamous cell carcinoma)
- History of drug or alcohol abuse within the last 2 years
- Contraindications for MRI scanning such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign object, or claustrophobia
- Insulin-dependent diabetes mellitus
- Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at
800-438-4380
or
email ADEAR.
Where Is This Study Located?
Source:
ClinicalTrials.gov ID:
NCT01128361