Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053599
Status:
COMPLETED
Last Update Posted:
2009-07-28
First Post:
2003-02-03
Brief Title:
Cholesterol Lowering Agent to Slow Progression CLASP of Alzheimers Disease Study
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Trial of Simvastatin to Slow the Progression of Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers 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 Alzheimers 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ADC-015-LL | None | None | None |