Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study

Phase 3

Completed

• 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.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2003-02-03
• Study First Submitted QC: 2003-02-03
• Study First Posted: 2003-02-04
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2009-06
• Last Update Submitted: 2009-07-24
• Last Update Posted: 2009-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (44)

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

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