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

Sponsor:	National Institute on Aging (NIA)
Collaborator:	Alzheimer's Disease Cooperative Study (ADCS)
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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Cholesterol Statins

Drug Information available for: Simvastatin

U.S. FDA Resources

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

Hide Study Locations

Locations

United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294-0017
United States, Arizona
Barrow Neurology Group
Phoenix, Arizona, United States, 85013
Arizona Health Sciences Center, University of Arizona
Tucson, Arizona, United States, 85724-5023
United States, California
Stanford University/VA Aging Clinical Research Center
Palo Alto, California, United States, 94304
University of California, Davis
Sacramento, California, United States, 95817
University of California, Irvine
Irvine, California, United States, 92697-7016
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Diego
La Jolla, California, United States, 92093-0948
University of Southern California
Los Angeles, California, United States, 90093
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
United States, District of Columbia
Georgetown University, Memory Disorder Program
Washington, District of Columbia, United States, 20057
Howard University
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic (Jacksonville)
Jacksonville, Florida, United States, 32224
Wein Center
Miami Beach, Florida, United States, 33140
Baumel Eisner Neuromedical Institute
Boca Raton, Florida, United States, 33486
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush Alzheimer's Disease Center, Rush University
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Alzheimer's Center
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Kentucky, Sanders-Brown Center on Aging
Lexington, Kentucky, United States, 40536-0230
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan at Ann Arbor
Ann Arbor, Michigan, United States, 48109-0504
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
United States, Missouri
Washington University, St. Louis School of Medicine
St. Louis, Missouri, United States, 63108
St. Louis University
St. Louis, Missouri, United States, 63104
United States, New York
Columbia University
New York, New York, United States, 10032
Mount Sinai School of Medicine
New York, New York, United States, 10029
Neurological Care of NY
Syracuse, New York, United States, 13210
SUNY Downstate
Brooklyn, New York, United States, 11203
SUNY Stony Brook
Stonybrook, New York, United States, 11794-8121
University of Rochester Medical Center
Rochester, New York, United States, 14642
New York University School Of Medicine
New York, New York, United States, 10016
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland
Cleveland, Ohio, United States, 44120
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97201
United States, Pennsylvania
University of Pennsylvania School of Medicine, Alzheimer's Disease Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University-Memorial Hospital of Rhode Island
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
United States, Texas
Baylor College of Medicine, Alzheimer's Disease Research Center
Houston, Texas, United States, 77030
University of Texas, Southwestern Medical School
Dallas, Texas, United States, 75390
United States, Vermont
Southwestern Vermont Medical Center
Bennington, Vermont, United States, 05201
United States, Washington
University of Washington at Seattle
Seattle, Washington, United States, 98108

Sponsors and Collaborators

National Institute on Aging (NIA)

Alzheimer's Disease Cooperative Study (ADCS)

Investigators

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

More Information

Additional 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:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00053599 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Cholesterol-lowering drug
Mild to Moderate Alzheimer disease

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Dementia
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2009