Cerebral and Peripheral Perfusion Pilot Study

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: atorvastatin

• Registration Number: NCT00751907
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Study First Submitted: 2008-09-10
• Study First Submitted QC: 2008-09-10
• Study First Posted: 2008-09-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	matching placebo nightly for 4 months
Atorvastatin	atorvastatin	40mg Atorvastatin nightly for 4 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in Endothelial function	Baseline and 4 months	Brachial artery reactivity was used to measure endothelial function

Trial Locations

Locations (1)

Karen Lazar; 🇺🇸 Madison, Wisconsin, United States