Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study
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|ClinicalTrials.gov Identifier: NCT00053599|
Recruitment Status : Completed
First Posted : February 4, 2003
Last Update Posted : July 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Simvastatin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Simvastatin to Slow the Progression of Alzheimer's Disease|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
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): NCT00053599
|Principal Investigator:||Mary Sano, PhD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Leon J. Thal, MD||University of California, San Diego|