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Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study)

Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study)

Authors :
C. Munro Cullum
Ann M. Stowe
David C. Zhu
Aditi Gupta
Linda S. Hynan
Rong Zhang
William P. Gahan
Amanda N. Szabo-Reed
Wanpen Vongpatanasin
Jeffrey M. Burns
Ellen F. Binder
Eric D. Vidoni
Diana R. Kerwin
Heidi Rossetti
Jeffrey N. Keller
Source :
Contemporary Clinical Trials. 79:44-54
Publication Year :
2019
Publisher :
Elsevier BV, 2019.

Abstract

Alzheimer's Disease (AD) is an age-related disease with modifiable risk factors such as hypertension, hypercholesterolemia, obesity, and physical inactivity influencing the onset and progression. There is however, no direct evidence that reducing these risk factors prevents or slows AD. The Risk Reduction for Alzheimer's Disease (rrAD) trial is designed to study the independent and combined effects of intensive pharmacological control of blood pressure and cholesterol and exercise training on neurocognitive function. Six hundred and forty cognitively normal older adults age 60 to 85 years with hypertension and increased risk for dementia will be enrolled. Participants are randomized into one of four intervention group for two years: usual care, Intensive Reduction of Vascular Risk factors (IRVR) with blood pressure and cholesterol reduction, exercise training (EX), and IRVR+EX. Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months. We hypothesize that both IRVR and EX will improve global cognitive function, while IRVR+EX will provide a greater benefit than either IRVR or EX alone. We also hypothesize that IRVR and EX will slow brain atrophy, improve brain structural and functional connectivity, and improve brain perfusion. Finally, we will explore the mechanisms by which study interventions impact neurocognition and brain. If rrAD interventions are shown to be safe, practical, and successful, our study will have a significant impact on reducing the risks of AD in older adults. NCT Registration: NCT02913664

Details

ISSN :
15517144
Volume :
79
Database :
OpenAIRE
Journal :
Contemporary Clinical Trials
Accession number :
edsair.doi.dedup.....52c863e288c47e82975ca342dc21c915
Full Text :
https://doi.org/10.1016/j.cct.2019.02.007