NCT02913664

Risk Reduction for Alzheimer's Disease

Exercise and Intensive Vascular Risk Reduction in Preventing Dementia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 513 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Numerous lines of evidence suggest that interventions that confer therapeutic benefits for cardiovascular health are also associated with improvements in, or preservation of, cognitive function. Many believe "What's good for the heart is good for the brain." However, stronge scientific evidence is needed to prove this hypothesis. The rrAD study is a 4-arm, multicenter, randomized trial to assess the effects of aerobic exercise training and intensive pharmacological reduction of vascular risk factors on cognitive performance in older adults who have high risk for AD, that is, those who have high blood pressure, family history of dementia or subjective memory complaints. Furthermore, rrAD will examine effects of exercise and vascular risk reduction on brain volume, perfusion, and neural network connectivity using magnetic resonance imaging (MRI).

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-02
• Primary completion: 2021-11-30
• Completion: 2022-01-31
• First posted: 2016-09-26
• Last updated: 2022-02-15

Locations

4 sites across 1 country: United States