Risk Reduction for Alzheimer's Disease

Summary

Physical inactivity, high blood pressure and dyslipidemia are risk factors for Alzheimer's disease (AD) and vascular dementia. Importantly, these risk factors are modifiable with lifestyle changes, pharmacological treatment, or both. The rrAD study will determine effects of aerobic exercise training and intensive vascular risk reduction on cognitive performance in older adults who have high risk for AD.

Conditions

• Cognitively Normal Older Adults
• Hypertension
• Subjective Cognitive Decline
• Family History of Alzheimer's Disease

Interventions

DRUG

Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine)

Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine) will be used to reduce SBP\<130 mmHg; atorvastatin 80 mg daily will be administered to reduce blood lipid level. Additional antihypertensives may be used if needed. Intensive Reduction of Vascular Risk Factors (IRVR)

BEHAVIORAL

Aerobic Exercise Training

Participants will take part in a supervised, moderate to vigorous aerobic exercise training program for approximately 24 months. This program consists of exercising 3 times per week for about 30 minutes per session at the beginning, and will increase to 4-5 times per week, 40-50 minutes per session over a period of 4-5 months. Exercise frequency, intensity and duration will be maintained at this level during the rest of the study period.

OTHER

Usual Care

Participants will follow their regular doctor's recommendations for blood pressure and lipid control.

BEHAVIORAL

Stretching Exercise

Participants will perform home-based stretching exercise 3 times per week, gradually increased to 4-5 times per week over a period of 4-5 months, and maintained at this level during the rest of the study period. They will be encouraged to attend monthly stretching exercise classes, which will be led by study staff or exercise trainers.

Sponsors & Collaborators

• Texas Health Resources

  collaborator OTHER

• University of Kansas Medical Center

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Pennington Biomedical Research Center

  collaborator OTHER

• Michigan State University

  collaborator OTHER

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Rong Zhang, PhD · UT Southwestern Medical Center

• Jeffrey Keller, PhD · Pennington Biomedical Research Center

• Jeffrey Burns, MD · University of Kansas Medical Center

• Ellen Binder, MD · Washington University School of Medicine

• Munro Cullum, PhD · UT Southwestern

• Diana Kerwin, MD · Texas Health Resources

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-02

Primary Completion

2021-11-30

Completion

2022-01-31

Countries

• United States

Study Locations