Cerebral and Peripheral Perfusion Pilot Study (CAPP)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Impact of Atorvastatin on Cerebral Perfusion and Endothelial Function|
- Perfusion in the posterior cingulate [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
- Endothelial function and pulse wave velocity [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
40mg daily for 4 months
Other Name: Lipitor
|Placebo Comparator: 2||
Matching placebo daily for 4 months
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 will evaluate whether administration of atorvastatin favorably alters blood flow in the brain (measured by magnetic resonance imaging (MRI)) and blood vessel function (measured by ultrasound).
Participants will be asked to attend 3 visits over the course of the 4-month study. At the initial visit, participants will complete a short questionnaire about their past medical history and medication history. At the baseline visit, participants will be randomized in a 1:1 ratio to receive atorvastatin 40 mg nightly vs. matching placebo. At baseline and follow-up visits, participants will provide an update on medical problems and medications, review any potential side effects, and have fasting blood tests collected for safety monitoring, including liver and muscle enzyme monitoring. In addition, all participants will have MRI and ultrasound measures collected.
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Cynthia M. Carlsson, MD, MS||University of Wisconsin School of Medicine and Public Health|