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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
513
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)
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.
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Washington University in St. Louis
St Louis, Missouri, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Change in global neurocognitive function
Alzheimer's Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite (ADCS-PACC) and NIH Toolbox (NIH-TB) Cognition Battery will be used to assess changes in neurocognitive function. The composite z-score for global cognition will be obtained by conversion of individual test scores to the standardized z-scores, then averaged to obtain a composite score.
Time frame: 2 Years
Domain-specific neurocognitive function assessed by using the tests included in the ADCS-PACC and NIH-TB Cognition.
Time frame: 2 Years
Whole brain and hippocampal volume assessed via Magnetic Resonance Imaging (MRI).
Time frame: 2 years
Global and regional brain perfusion assessed via Magnetic Resonance Imaging (MRI).
Time frame: 2 years
Brain white matter hyperintensity (WMH) assessed via Magnetic Resonance Imaging (MRI).
Time frame: 2 years
Brain white matter microstructural integrity assessed via Magnetic Resonance Imaging (MRI).
Time frame: 2 years
Brain neural network functional connectivity assessed via functional Magnetic Resonance Imaging (MRI).
Time frame: 2 years
Patient-reported outcomes (PRO) of mental and physical health and health-related quality of life assessed by using NIH PROMIS.
Time frame: 2 years
Physical function assessed via the Short Physical Performance Battery (SPPB).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will follow their regular doctor's recommendations for blood pressure and lipid control.
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.
Time frame: 2 years
Dual task performance assessed via distracted and non-distracted 10 meter walk.
Time frame: 2 years