Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study
NCT ID: NCT00053599
Last Updated: 2009-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2002-12-31
2007-10-31
Brief Summary
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Detailed Description
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CLASP is a research study to investigate the safety and effectiveness of simvastatin (a cholesterol lowering drug or statin) to slow the progression of AD. The clinical trial will include the treatment of patients with mild to moderate AD, and the objective is to evaluate the safety and efficacy of simvastatin to slow the progression of AD, as measured by the cognitive portion of the AD Assessment Scale. Measures of clinical global change (ADCS-CGIC), mental status, functional ability, behavioral disturbances, quality of life and economic indicators will be made also. The study design is randomized, double-blind, placebo-controlled, parallel group design with equal randomization to drug and placebo. Randomization will be stratified and blocked to ensure balanced assignment within site. Sample size will include 400 participants enrolled from approximately 40 sites with a goal of 10 to 15 volunteers enrolled at each site. Study medication will be as follows: 20 mg of simvastatin or matching placebo to be given for 6 weeks, followed by 40 mg of simvastatin or matching placebo for the remainder of the 18-month study period. Participants will be instructed to take the medication once a day in the evening. Safety parameters to be checked will include adverse events, symptom checklists, vital signs, physical and neurological examinations, and laboratory tests.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Simvastatin
Eligibility Criteria
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Exclusion Criteria
* Informant/study partner available and willing to accompany participant to all scheduled visits and complete informant-based assessments and to supervise administration of study medications.
* Fluent in English or Spanish.
* Modified Hachinski is less than or equal to 4.
* 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.
* Active neoplastic disease (skin tumors other than melanoma are not exclusionary; subjects with stable prostate cancer may be included at the discretion of the Project Director).
* 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.
50 Years
ALL
No
Sponsors
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Alzheimer's Disease Cooperative Study (ADCS)
OTHER
National Institute on Aging (NIA)
NIH
Principal Investigators
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Mary Sano, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Leon J. Thal, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
Barrow Neurology Group
Phoenix, Arizona, United States
Arizona Health Sciences Center, University of Arizona
Tucson, Arizona, United States
University of California, Irvine
Irvine, California, United States
University of California, San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Stanford University/VA Aging Clinical Research Center
Palo Alto, California, United States
University of California, Davis
Sacramento, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University, Memory Disorder Program
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Baumel Eisner Neuromedical Institute
Boca Raton, Florida, United States
Mayo Clinic (Jacksonville)
Jacksonville, Florida, United States
Wein Center
Miami Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush Alzheimer's Disease Center, Rush University
Chicago, Illinois, United States
Indiana University Alzheimer's Center
Indianapolis, Indiana, United States
University of Kentucky, Sanders-Brown Center on Aging
Lexington, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston University School of Medicine
Boston, Massachusetts, United States
University of Michigan at Ann Arbor
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Louis University
St Louis, Missouri, United States
Washington University, St. Louis School of Medicine
St Louis, Missouri, United States
SUNY Downstate
Brooklyn, New York, United States
New York University School Of Medicine
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY Stony Brook
Stony Brook, New York, United States
Neurological Care of NY
Syracuse, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland
Cleveland, Ohio, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Pennsylvania School of Medicine, Alzheimer's Disease Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Brown University-Memorial Hospital of Rhode Island
Providence, Rhode Island, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
University of Texas, Southwestern Medical School
Dallas, Texas, United States
Baylor College of Medicine, Alzheimer's Disease Research Center
Houston, Texas, United States
Southwestern Vermont Medical Center
Bennington, Vermont, United States
University of Washington at Seattle
Seattle, Washington, United States
Countries
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References
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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.
Jick 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.
Simons 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.
Related Links
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Alzheimer's Disease Cooperative Study
Other Identifiers
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ADC-015-LL
Identifier Type: -
Identifier Source: secondary_id
IA0038
Identifier Type: -
Identifier Source: org_study_id
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