Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study - Full Text View

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00053599

Purpose

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.

Condition	Intervention	Phase
Alzheimer Disease	Drug: Simvastatin	Phase III

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Cholesterol Statins

Drug Information available for: Simvastatin Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Simvastatin to Slow the Progression of Alzheimer's Disease

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment:	400
Study Start Date:	December 2002
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Mild to moderate patients with AD who are free of life-threatening disease and who do not require lipid-lowering treatment according to current guidelines.
NINCDS/ADRDA criteria for probable AD.
Mini-Mental-State-Exam (MMSE) score between 12 and 26.
Stable medical condition for 3 months prior to the screening visit.
Age greater than or equal to 50 years, and no upper age limit.
Lives in a community dwelling, not in a nursing home.
Stable doses of (non-excluded) medications with central nervous system activity for 4 weeks prior to the screening visit.
Physical condition acceptable for the study as confirmed by medical history, physical exam, neurologic exam and clinical laboratory tests.
Informant/study partner available and willing to accompany participant to all scheduled visits and complete informant-based assessments and to supervise administration of study medications.
Fluent in English or Spanish.
Modified Hachinski is less than or equal to 4.

Exclusion criteria:

Coronary heart disease (CHD) including angina, or peripheral vascular disease including symptomatic carotid artery disease, or stroke or TIA, as these individuals are likely to require treatment with lipid-lowering drugs.
Serious renal disease.
Uncontrolled diabetes.
Triglycerides are greater than 500 mg/dL.
LDL-Cholesterol below 80 mg/dL
Upper limit for the National Cholesterol Education Program (NCEP) guidelines for LDL-Cholesterol is 130-190 mg/dL, depending on age and other cardiovascular risk factors.
Other indication for the need to treat with lipid-lowering drug.
Active liver disease or persistent elevation in serum transaminase.
Active neoplastic disease (skin tumors other than melanoma are not exclusionary; subjects with stable prostate cancer may be included at the discretion of the Project Director).
Use of another investigational agent within 2 months of the screening visit.
History of clinically significant stroke.
Current evidence or history in the past 2 years of seizures, head injury with loss of consciousness and/or immediate confusion after the injury.
Current DSM-IV criteria based diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
Blindness, deafness, language difficulties or any other disability which may prevent the subject from participating or cooperating in the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053599

Show 44 Study Locations

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:	Mary Sano, PhD	Mount Sinai School of Medicine
Principal Investigator:	Leon J. Thal, MD	University of California, San Diego

More Information

Alzheimer's Disease Cooperative Study This link exits the ClinicalTrials.gov site

Publications:

Hartmann T. Cholesterol, A beta and Alzheimer's disease. Trends Neurosci. 2001 Nov;24(11 Suppl):S45-8. Review.

Jick H, Zornberg GL, Jick SS, Seshadri S, Drachman DA. Statins and the risk of dementia. Lancet. 2000 Nov 11;356(9242):1627-31.

Simons M, Schwarzler F, Lutjohann D, von Bergmann K, Beyreuther K, Dichgans J, Wormstall H, Hartmann T, Schulz JB. Treatment with simvastatin in normocholesterolemic patients with Alzheimer's disease: A 26-week randomized, placebo-controlled, double-blind trial. Ann Neurol. 2002 Sep;52(3):346-50.

Study ID Numbers:	IA0038, ADC-015-LL
Study First Received:	February 3, 2003
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00053599
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Cholesterol-lowering drug
Mild to Moderate Alzheimer disease

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Simvastatin
Mental Disorders
Alzheimer Disease
Disease Progression
Central Nervous System Diseases

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Nervous System Diseases

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Tauopathies
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009