Evaluating Simvastatin's Potential Role in Therapy

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects processes related to the development of Alzheimer's disease, including: 1) levels of a substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood flow in the brain, 3) inflammation in the brain, and 4) cognitive function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: American Federation for Aging Research; Merck Sharp & Dohme Corp.; National Institute on Aging (NIA); Paul Beeson Faculty Scholars Program; Starr Foundation; The Atlantic Philanthropies; The John A. Hartford Foundation
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Age 35 to 69

• Parent with Alzheimer's disease

Exclusion Criteria:

• Current use of cholesterol-lowering medication

• Active liver disease

• History of adverse reaction to statins

• Contraindication to lumbar puncture

• Elevated lab values (creatine kinase and creatinine)

• Use of medications known to interact with statins

• History of dementia

• Currently pregnant or planning to become pregnant

• Use of large quantities of grapefruit juice (more than 1 quart per day)

• Current involvement in another investigational drug study

• Contraindications to MRI (for MRI sub-study)

• Ethical contraindication to placebo (persons with high vascular risk)