Alzheimer's Disease Education and Referral Center

Aerobic Exercise in Early Alzheimer's Disease

Aerobic Exercise in Early Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
N/A
Both
No
Inclusion Criteria: 
    • 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
Exclusion Criteria: 
    • 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
Detailed Description: 

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.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 39.06, -94.61

Site
Kansas City
Kansas
66160
Recruiting
Name: Jeffry Burns, MD
Phone: 913-588-0073
Email: jburns2@kumc.edu
Lead Sponsor: 
Agency
Jeffrey Burns, MD
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Jeffrey Burns, MD
Principal Investigator
University of Kansas Medical Center
Study Contact: 
NamePhoneEmail
Pat Laubinger
913-588-0685
Locations
 
 
ClinicalTrials.gov ID 
NCT01128361 (follow link to view full record on ct.gov in new window)
Official Title: 
Alzheimer's Disease Exercise Prevention Trial
Study Start Date: 
May 2010
Study End Date: 
January 2015
Disease Stage: 
Early
Middle
Enrollment: 
80