Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Simvastatin to Slow the Progression of Alzheimer's Disease
2 other identifiers
interventional
400
1 country
44
Brief Summary
CLASP is a research study to investigate the safety and effectiveness of simvastatin (a cholesterol lowering drug or statin) to slow the progression of Alzheimer's disease (AD). Statins are commonly used to treat high cholesterol levels, which increase the risk of heart disease and stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 alzheimer-disease
Started Dec 2002
Longer than P75 for phase_3 alzheimer-disease
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 3, 2003
CompletedFirst Posted
Study publicly available on registry
February 4, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedJuly 28, 2009
June 1, 2009
4.8 years
February 3, 2003
July 24, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may not qualify if:
- Coronary heart disease (CHD) including angina, or peripheral vascular disease including symptomatic carotid artery disease, or stroke or TIA, as these individuals are likely to require treatment with lipid-lowering drugs.
- Serious renal disease.
- Uncontrolled diabetes.
- Triglycerides are greater than 500 mg/dL.
- LDL-Cholesterol below 80 mg/dL
- Upper limit for the National Cholesterol Education Program (NCEP) guidelines for LDL-Cholesterol is 130-190 mg/dL, depending on age and other cardiovascular risk factors.
- Other indication for the need to treat with lipid-lowering drug.
- Active liver disease or persistent elevation in serum transaminase.
- Use of another investigational agent within 2 months of the screening visit.
- History of clinically significant stroke.
- Current evidence or history in the past 2 years of seizures, head injury with loss of consciousness and/or immediate confusion after the injury.
- Current DSM-IV criteria based diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
- Blindness, deafness, language difficulties or any other disability which may prevent the subject from participating or cooperating in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
University of Alabama, Birmingham
Birmingham, Alabama, 35294-0017, United States
Barrow Neurology Group
Phoenix, Arizona, 85013, United States
Arizona Health Sciences Center, University of Arizona
Tucson, Arizona, 85724-5023, United States
University of California, Irvine
Irvine, California, 92697-7016, United States
University of California, San Diego
La Jolla, California, 92093-0948, United States
University of Southern California
Los Angeles, California, 90093, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Stanford University/VA Aging Clinical Research Center
Palo Alto, California, 94304, United States
University of California, Davis
Sacramento, California, 95817, United States
Yale University School of Medicine
New Haven, Connecticut, 06511, United States
Georgetown University, Memory Disorder Program
Washington D.C., District of Columbia, 20057, United States
Howard University
Washington D.C., District of Columbia, 20060, United States
Baumel Eisner Neuromedical Institute
Boca Raton, Florida, 33486, United States
Mayo Clinic (Jacksonville)
Jacksonville, Florida, 32224, United States
Wein Center
Miami Beach, Florida, 33140, United States
Emory University
Atlanta, Georgia, 30329, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush Alzheimer's Disease Center, Rush University
Chicago, Illinois, 60612, United States
Indiana University Alzheimer's Center
Indianapolis, Indiana, 46202, United States
University of Kentucky, Sanders-Brown Center on Aging
Lexington, Kentucky, 40536-0230, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
University of Michigan at Ann Arbor
Ann Arbor, Michigan, 48109-0504, United States
Mayo Clinic
Rochester, Minnesota, 55901, United States
St. Louis University
St Louis, Missouri, 63104, United States
Washington University, St. Louis School of Medicine
St Louis, Missouri, 63108, United States
SUNY Downstate
Brooklyn, New York, 11203, United States
New York University School Of Medicine
New York, New York, 10016, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY Stony Brook
Stony Brook, New York, 11794-8121, United States
Neurological Care of NY
Syracuse, New York, 13210, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland
Cleveland, Ohio, 44120, United States
Oregon Health and Sciences University
Portland, Oregon, 97201, United States
University of Pennsylvania School of Medicine, Alzheimer's Disease Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Brown University-Memorial Hospital of Rhode Island
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
North Charleston, South Carolina, 29406, United States
University of Texas, Southwestern Medical School
Dallas, Texas, 75390, United States
Baylor College of Medicine, Alzheimer's Disease Research Center
Houston, Texas, 77030, United States
Southwestern Vermont Medical Center
Bennington, Vermont, 05201, United States
University of Washington at Seattle
Seattle, Washington, 98108, United States
Related Publications (3)
Hartmann T. Cholesterol, A beta and Alzheimer's disease. Trends Neurosci. 2001 Nov;24(11 Suppl):S45-8. doi: 10.1016/s0166-2236(00)01990-1.
PMID: 11881745BACKGROUNDJick H, Zornberg GL, Jick SS, Seshadri S, Drachman DA. Statins and the risk of dementia. Lancet. 2000 Nov 11;356(9242):1627-31. doi: 10.1016/s0140-6736(00)03155-x.
PMID: 11089820BACKGROUNDSimons M, Schwarzler F, Lutjohann D, von Bergmann K, Beyreuther K, Dichgans J, Wormstall H, Hartmann T, Schulz JB. Treatment with simvastatin in normocholesterolemic patients with Alzheimer's disease: A 26-week randomized, placebo-controlled, double-blind trial. Ann Neurol. 2002 Sep;52(3):346-50. doi: 10.1002/ana.10292.
PMID: 12205648BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Sano, PhD
Icahn School of Medicine at Mount Sinai
- PRINCIPAL INVESTIGATOR
Leon J. Thal, MD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 3, 2003
First Posted
February 4, 2003
Study Start
December 1, 2002
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
July 28, 2009
Record last verified: 2009-06