Risk Reduction for Alzheimer's Disease
Condition: Cognitively Normal Older Adults; Hypertension; Subjective Cognitive Decline; Family History of Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2/Phase 3

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).
    

Intervention name(s): Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine); Aerobic Exercise Training; Usual Care; Stretching Exercise
Intervention type(s): Drug; Behavioral; Other; Behavioral
Intervention description(s): 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.; 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.
Intervention MeSH terms: Losartan; Amlodipine; Calcium Channel Blockers; Angiotensin II; Giapreza; Calcium; Angiotensin Receptor Antagonists; Angiotensinogen
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dementia; Alzheimer's Disease; Cognitive Function; Blood Pressure; Cholesterol; Physical Activity; Exercise; Magnetic Resonance Imaging