Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00053599
- Lead Sponsor
- National Institute on Aging (NIA)
- 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.
- Detailed Description
In earlier studies in animals and humans, researchers found that lowering cholesterol levels with statins seems to have a positive impact on brain function and reduces the risk of AD. The CLASP trial will test the link between using a cholesterol lowering medication and slowing disease progress in people with mild to moderate Alzheimer's disease (AD).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Neurological Care of NY
🇺🇸Syracuse, New York, United States
University of Pennsylvania School of Medicine, Alzheimer's Disease Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Wein Center
🇺🇸Miami Beach, Florida, United States
Medical University of South Carolina
🇺🇸North Charleston, South Carolina, United States
Rush Alzheimer's Disease Center, Rush University
🇺🇸Chicago, Illinois, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
New York University School Of Medicine
🇺🇸New York, New York, United States
Stanford University/VA Aging Clinical Research Center
🇺🇸Palo Alto, California, United States
Mayo Clinic (Jacksonville)
🇺🇸Jacksonville, Florida, United States
Brown University-Memorial Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Washington University, St. Louis School of Medicine
🇺🇸St. Louis, Missouri, United States
Southwestern Vermont Medical Center
🇺🇸Bennington, Vermont, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
SUNY Downstate
🇺🇸Brooklyn, New York, United States
University of Kentucky, Sanders-Brown Center on Aging
🇺🇸Lexington, Kentucky, United States
SUNY Stony Brook
🇺🇸Stonybrook, New York, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas, Southwestern Medical School
🇺🇸Dallas, Texas, United States
Barrow Neurology Group
🇺🇸Phoenix, Arizona, United States
University of Washington at Seattle
🇺🇸Seattle, Washington, United States
Indiana University Alzheimer's Center
🇺🇸Indianapolis, Indiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States
Baylor College of Medicine, Alzheimer's Disease Research Center
🇺🇸Houston, Texas, United States
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
University of California, Irvine
🇺🇸Irvine, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Georgetown University, Memory Disorder Program
🇺🇸Washington, District of Columbia, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Baumel Eisner Neuromedical Institute
🇺🇸Boca Raton, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
St. Louis University
🇺🇸St. Louis, Missouri, United States
Columbia University
🇺🇸New York, New York, United States
Arizona Health Sciences Center, University of Arizona
🇺🇸Tucson, Arizona, United States
University of Michigan at Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
University of California, Davis
🇺🇸Sacramento, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States