Evaluating Simvastatin's Potential Role in Therapy (ESPRIT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Statins on Pathobiology of Alzheimer's Disease|
- Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42 [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
- Changes in Regional Cerebral Blood Flow on MRI [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]Mean changes noted in posterior cingulate cortex
- Change in Inflammatory Markers [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]Change noted in serum high-sensitivity c-reactive protein
- Changes in Cognitive Performance [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: No ]
Change in Hopkins Verbal Learning Test Delayed Recall
The Hopkins Verbal Learning Test Delayed Recall score is the raw number of words recalled at Trial 4, adjusted for years of education and age. This is a 12-item word list test.
|Study Start Date:||February 2005|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
simvastatin 40 mg nightly for 1 month then 80 mg nightly for 8 months
40 mg tablet each night for one month, then 80 mg for 8 months
Other Name: Zocor
Placebo Comparator: Placebo
Matching placebo tablet nightly for 9 months
Matching tablet each night for 9 months
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486044
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Cynthia M. Carlsson, MD, MS||University of Wisconsin, Madison|