![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date † | February 3, 2003 | ||||||||
Last Updated Date | April 7, 2009 | ||||||||
Start Date † | December 2002 | ||||||||
Current Primary Outcome Measures † | |||||||||
Original Primary Outcome Measures † | |||||||||
Change History | Complete list of historical versions of study NCT00053599 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study | ||||||||
Official Title † | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Simvastatin to Slow the Progression of Alzheimer's Disease | ||||||||
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 Phase | Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
Condition † | Alzheimer Disease | ||||||||
Intervention † | Drug: Simvastatin | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * |
|
||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status † | Completed | ||||||||
Enrollment † | 400 | ||||||||
Completion Date | October 2007 | ||||||||
Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † |
Exclusion criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 50 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00053599 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | ADC-015-LL | ||||||||
Study Sponsor † | National Institute on Aging (NIA) | ||||||||
Collaborators †† | |||||||||
Investigators † |
|
||||||||
Information Provided By | National Institute on Aging (NIA) | ||||||||
Verification Date | February 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |