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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)
- 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
- Subjects :
- Blood Glucose
Male
Research design
medicine.medical_specialty
Health Behavior
Psychological intervention
Blood Pressure
Disease
Article
Body Mass Index
03 medical and health sciences
0302 clinical medicine
Alzheimer Disease
Internal medicine
medicine
Humans
Dementia
Pharmacology (medical)
030212 general & internal medicine
Life Style
Antihypertensive Agents
Aged
Aged, 80 and over
030505 public health
business.industry
Brain
General Medicine
Middle Aged
Mental Status and Dementia Tests
medicine.disease
Magnetic Resonance Imaging
Exercise Therapy
Clinical trial
Cholesterol
Blood pressure
Research Design
Hypertension
Female
Atrophy
Alzheimer's disease
0305 other medical science
business
Risk Reduction Behavior
Neurocognitive
Subjects
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