Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2005-02-28
2009-06-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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simvastatin
simvastatin 40 mg nightly for 1 month then 80 mg nightly for 8 months
Simvastatin
40 mg tablet each night for one month, then 80 mg for 8 months
Placebo
Matching placebo tablet nightly for 9 months
Placebo
Matching tablet each night for 9 months
Interventions
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Simvastatin
40 mg tablet each night for one month, then 80 mg for 8 months
Placebo
Matching tablet each night for 9 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Parent with Alzheimer's disease
Exclusion Criteria
* 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)
35 Years
69 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Paul Beeson Faculty Scholars Program
OTHER
The John A. Hartford Foundation
OTHER
The Atlantic Philanthropies
OTHER
Starr Foundation
OTHER
American Federation for Aging Research
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Cynthia M. Carlsson, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Fassbender K, Simons M, Bergmann C, Stroick M, Lutjohann D, Keller P, Runz H, Kuhl S, Bertsch T, von Bergmann K, Hennerici M, Beyreuther K, Hartmann T. Simvastatin strongly reduces levels of Alzheimer's disease beta -amyloid peptides Abeta 42 and Abeta 40 in vitro and in vivo. Proc Natl Acad Sci U S A. 2001 May 8;98(10):5856-61. doi: 10.1073/pnas.081620098. Epub 2001 Apr 10.
Wolozin B. A fluid connection: cholesterol and Abeta. Proc Natl Acad Sci U S A. 2001 May 8;98(10):5371-3. doi: 10.1073/pnas.101123198. No abstract available.
Johnson NA, Jahng GH, Weiner MW, Miller BL, Chui HC, Jagust WJ, Gorno-Tempini ML, Schuff N. Pattern of cerebral hypoperfusion in Alzheimer disease and mild cognitive impairment measured with arterial spin-labeling MR imaging: initial experience. Radiology. 2005 Mar;234(3):851-9. doi: 10.1148/radiol.2343040197.
Related Links
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Wisconsin Alzheimer's Disease Research Center
Other Identifiers
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IA0116
Identifier Type: -
Identifier Source: org_study_id
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