Cerebral and Peripheral Perfusion Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atorvastatin

40mg Atorvastatin nightly for 4 months

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

40mg daily for 4 months

Placebo

matching placebo nightly for 4 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo daily for 4 months

Interventions

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atorvastatin

40mg daily for 4 months

Intervention Type DRUG

Placebo

Matching placebo daily for 4 months

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes