CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 513 enrolled
Drug / intervention
Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine) +3 moredrug
Likely dose
Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine) 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02913664
NCT02913664Phase 3Completed
CompareCT.gov

Exercise and Intensive Vascular Risk Reduction in Preventing Dementia

University of Texas Southwestern Medical Center·interventional·Posted Sep 26, 2016·Updated Feb 15, 2022

In Brief

A Phase 3 clinical trial evaluating Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine), Aerobic Exercise Training, and 2 other interventions for Cognitively Normal Older Adults and 3 related conditions. Completed, enrolled 513 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCognitively Normal Older Adults, Hypertension, Subjective Cognitive Decline, Family History of Alzheimer's Disease
CountriesUnited States
CollaboratorsTexas Health Resources, University of Kansas Medical Center, Washington University School of Medicine, Pennington Biomedical Research Center, Michigan State University

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 26, 2016
Enrollment StartFeb 2, 2017
Primary CompletionNov 30, 2021
Study CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.8 years ago

Interventions

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

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)

Aerobic Exercise Trainingbehavioral

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.

Usual Careother

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

Stretching Exercisebehavioral

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.