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Exercise and Vascular Risk Reduction for Alzheimer's

Recruiting

Physical inactivity, high blood pressure, and high cholesterol levels are risk factors for Alzheimer's disease and vascular dementia; however, these risk factors are modifiable with lifestyle changes and medications. 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.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years 85 Years All No
September 2016
September 2022
640

  • 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 healthcare provider
  • Ability to undergo exercise training (able to walk 10 minutes without pain)
  • Fluent in English

  • 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 6 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 1 week)
  • Systolic blood pressure less than 100 mmHg (may be rescreened in 2 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 5 years
  • Uncontrolled diabetes: hemoglobin A1C greater than 7.5 percent or requiring insulin treatment
  • Regularly smoked cigarettes within the past year
  • If female, must be 2 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 2 weeks or longer)
  • Medical condition likely to limit survival to less than 3 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 healthcare providers
  • Enrollment in another investigational drug or device study currently or within the past 2 months

Participants in this 2-year study will be randomly assigned to one of four groups: 1) 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), 2) medications taken daily to reduce high blood pressure and high cholesterol levels, 3) a combination of exercise and medications, or 4) 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.

For more information about this study, visit www.rradtrial.org.

Name City State Zip Status Primary Contact
University of Kansas Medical Center Research Institute
Kansas City Kansas 66160 Recruiting Angela VanSciver
913-945-5029
avansciver@kumc.edu
Pennington Biomedical Research Center
Baton Rouge Louisiana 70808 Recruiting Sara Goff
225-763-0910
sara.goff@pbrc.edu
Washington University in St. Louis
St. Louis Missouri 63110 Recruiting Monica Sewell
314-286-2716
sewellm@wustl.edu
UT Southwestern Medical Center
Dallas Texas 75390 Recruiting Lauren Braunfeld
214-345-7134
LaurenBraunfeld@texashealth.org

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

Name Role Affiliation
Rong Zhang, PhD Principal Investigator UT Southwestern
Jeffrey Keller, PhD Principal Investigator Pennington Biomedical Research Center
Jeffrey Burns, MD Principal Investigator University of Kansas Medical Center
Ellen Binder, MD Principal Investigator Washington University School of Medicine
Munro Cullum, PhD Principal Investigator UT Southwestern
Diana Kerwin, MD Principal Investigator Texas Health Resources

Name Phone Email
Lauren Braunfeld 214-345-7134 laurenbraunfeld@texashealth.org
Marcel Turner 214-345-4973 marcelturner@texashealth.org

NCT02913664

Exercise and Intensive Vascular Risk Reduction in Preventing Dementia