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Aerobic Exercise in Early Alzheimer's Disease

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?

Minimum Age: 55 Years

Maximum Age: N/A

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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

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?

Who Sponsors This Study?

Lead: Jeffrey Burns, MD

Source: ClinicalTrials.gov ID: NCT01128361