Cerebral and Peripheral Perfusion Pilot Study (CAPP)

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: atorvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00751907

Pilot Award (Other Grant/Funding Number)

IA0138

K23AG026752 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Atorvastatin

Experimental group

Description:

40mg Atorvastatin nightly for 4 months

Treatment:

Drug: atorvastatin

Placebo

Placebo Comparator group

Description:

matching placebo nightly for 4 months

Treatment:

Drug: Placebo