Evaluating Simvastatin's Potential Role in Therapy (ESPRIT)
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|ClinicalTrials.gov Identifier: NCT00486044|
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : November 5, 2015
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Simvastatin Drug: Placebo||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Statins on Pathobiology of Alzheimer's Disease|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
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
- Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42 [ Time Frame: baseline and 9 months ]
- Changes in Regional Cerebral Blood Flow on MRI [ Time Frame: baseline and 9 months ]Mean changes noted in posterior cingulate cortex
- Change in Inflammatory Markers [ Time Frame: baseline and 9 months ]Change noted in serum high-sensitivity c-reactive protein
- Changes in Cognitive Performance [ Time Frame: Baseline and 9 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486044
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Cynthia M. Carlsson, MD, MS||University of Wisconsin, Madison|