Alzheimer's Disease
Conditions
Keywords
Cerebral blood flow
Brief summary
The purpose of this study is to evaluate the hypothesis that in middle-aged, asymptomatic, adult children of persons with Alzheimer's disease (AD), atorvastatin therapy will beneficially affect mechanisms thought to contribute to AD risk by improving blood flow in the brain, improving cerebral perfusion, increasing brain activity patterns, and improving blood vessel function.
Detailed description
Treatment with cholesterol-lowering medications, specifically statins, is associated with up to a 73% reduction in the prevalence of AD, suggesting a potentially promising role for statins in the prevention of AD. In order to better understand the mechanisms through which statins may possibly modify blood AD risk, this study evaluated whether administration of atorvastatin favorably altered blood flow in the brain (measured by magnetic resonance imaging (MRI)) and blood vessel function (measured by ultrasound). Participants attended 3 visits over the course of the 4-month study. At the initial visit, participants completed a short questionnaire about their past medical history and medication history. At the baseline visit, participants were randomized in a 1:1 ratio to receive atorvastatin 40 mg nightly vs. matching placebo. At baseline and follow-up visits, participants provided an update on medical problems and medications, reviewed any potential side effects, and had fasting blood tests collected for safety monitoring, including liver and muscle enzyme monitoring. In addition, all participants had MRI and ultrasound measures collected.
Interventions
DRUGatorvastatin
40mg daily for 4 months
DRUGPlacebo
Matching placebo daily for 4 months
Sponsors
National Institute on Aging (NIA)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult (ages 40-65) children of parent with documented Alzheimer's disease
Exclusion criteria
* Current use of cholesterol lowering medication * History of liver disease * History of adverse reaction to statin medications * Elevated lab values (CK and creatinine) * Use of medications that counteract with atorvastatin * History of dementia * Currently pregnant * Use of large quantities of grapefruit juice (more than 1 quart/day) * Current involvement in another investigational drug study * Contraindications to MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in regional cerebral blood flow (rCBF) | Baseline and 4 months | rCBF , a measure of cerebral perfusion, is the primary outcome. rCBF was measured by arterial spin-labeling magnetic resonance imaging and used to evaluate effects of atorvastatin vs placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Endothelial function | Baseline and 4 months | Brachial artery reactivity was used to measure endothelial function |
Countries
United States
Outcome results
None listed