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Aerobic Exercise in Early Alzheimer's Disease

Completed

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.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years N/A Both No
May 2010
January 2015
80

  • 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

  • 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

This study will compare the effects of aerobic exercise to those of stretching and toning on cognition and daily functioning in people with early-stage Alzheimer's disease. Participants in the exericse group will perform 150 minutes per week of aerobic exercise for 3 to 5 days. They will exercise in three 20-minute sessions the first week, increasing to three 25-minute sessions the second week and so on until they reach a total of 150 minutes in week 6. Exercise traininers will assist participants and monitor their safety. Each participant will wear a heart monitor while exercising. Most sessions will involve walking on a treadmill.

Name City State Zip Status Primary Contact
University of Kansas Medical Center
Kansas City Kansas 66160 n/a

Jeffrey Burns, MD

Name Role Affiliation
Jeffrey Burns, MD Principal Investigator University of Kansas Medical Center

Name Phone Email
Pat Laubinger 913-588-0685 plaubinger@kumc.edu

NCT01128361

Alzheimer's Disease Exercise Prevention Trial