Start: September 2016
End: September 2022
What Is This Study About?
This study will test the effects of aerobic exercise and vascular risk reduction on cognitive performance in older adults who are at risk for Alzheimer's disease. Participants in this two-year study will be randomly assigned to one of four groups: aerobic exercise, starting with three times per week for 30 minutes and increasing to four to five times per week for 40 to 50 minutes; medications taken daily to reduce high blood pressure and high cholesterol levels; a combination of exercise and medications; or a control group receiving their usual care. Medications being administered in this study include losartan (Cozaar), amlodipine (Amvaz, Norvasc), and atorvastatin (Lipitor). Researchers will measure changes in cognitive function and the effects of exercise and vascular risk reduction on brain volume, blood flow, and neural network connectivity using magnetic resonance imaging.
Do I Qualify To Participate in This Study?
- Family history of dementia (at least one first-degree relative with Alzheimer's or other dementia) or subjective cognitive decline
- Mini-Mental State Examination score of 26 or higher (to exclude gross dementia)
- Sedentary lifestyle
- Hypertension (systolic blood pressure higher than 130 mmHg)
- Adequate visual and auditory ability to allow neuropsychological testing
- Regular health care provider
- Ability to undergo exercise training (able to walk 10 minutes without pain)
- Fluent in English
Must NOT have:
- History of stroke, focal neurological signs, or other major cerebrovascular diseases
- Diagnosis of Alzheimer's or other dementia or significant neurologic disease, such as Parkinson's disease, seizure disorder, or multiple sclerosis
- History of severe head trauma or normal pressure hydrocephalus
- Evidence of major depression or psychosis, including schizophrenia
- Unstable heart disease (e.g., heart attack/cardiac arrest, cardiac bypass procedures within past six months, and congestive heart failure) or other severe medical conditions
- Evidence of atrial fibrillation on electrocardiogram
- Systolic blood pressure 180 mmHg or higher and/or diastolic blood pressure 110 mmHg or higher (may be rescreened in one week)
- Systolic blood pressure less than 100 mmHg (may be rescreened in two weeks)
- History of significant autoimmune disorders, such as systemic lupus erythematosus, rheumatoid arthritis, or polymyalgia rheumatica
- History of alcoholism or drug abuse within the last five years
- Uncontrolled diabetes: hemoglobin A1C greater than 7.5% or requiring insulin treatment
- Regularly smoked cigarettes within the past year
- If female, must be two years postmenopausal or surgically sterile
- Severe obesity with a body mass index of 45 or higher
- Allergy to angiotensin receptor blockers (drugs that have a suffix "sartan") or to other study drugs or their ingredients
- Abnormal screening laboratory tests (may be rescreened after two weeks or longer)
- Medical condition likely to limit survival to less than three years
- Residence too far from the study clinic site such that transportation is a barrier
- Residence in a nursing home; persons residing in an assisted living or retirement community are eligible
- Couples or partners who live together cannot participate simultaneously
- Lack of approval from participant's regular health care providers
- Enrollment in another investigational drug or device study currently or within the past two months
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Who Is the General Study Contact?
For more information about this study, visit www.rradtrial.org.
Where Is This Study Located?
Lead: University of Texas Southwestern Medical Center
Texas Health Resources
University of Kansas Medical Center
Washington University School of Medicine
Pennington Biomedical Research Center
Michigan State University
Source: ClinicalTrials.gov ID: NCT02913664