Alzheimer Disease Clinical Trial
Official title:
Effect of Statins on Pathobiology of Alzheimer's Disease
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.
Some studies suggest that statin medications, which are a group of cholesterol-lowering
medicines, may help prevent Alzheimer's disease. However, this has not been proven in humans.
The purpose of this study is to see how simvastatin affects a substance in the spinal fluid
around the brain called beta-amyloid-42 which is thought to contribute to Alzheimer's
disease. This study also evaluates whether simvastatin improves regional brain blood flow (on
magnetic resonance imaging [MRI]), reduces inflammation, and improves cognitive function.
The ESPRIT study was a 9-month randomized, controlled clinical trial that randomized 100
middle-aged adults with a parental history of Alzheimer's disease. Participants were
randomized to simvastatin 40 mg for one month then 80 mg daily or matching placebo tablets.
Fifty of the ESPRIT subjects participated in the MRI sub-study.
Participants had the following data collected: fasting blood tests (baseline and months 3 and
9), medical history and medication questionnaires (each visit), study medication side effect
review (all visits), lumbar puncture procedure (baseline and month 9), memory testing
(baseline and months 3 and 9), and MRI (baseline and month 9 in 50 sub-study participants).
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