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

Completed · Phase 3

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT00053599

Run by

National Institute on Aging (NIA)

People needed

400

Starts

2002-12-01

Expected to finish

2007-10-01

Last updated by the study team

2009-07-28

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• 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
• Georgetown University, Memory Disorder Program — Washington D.C., District of Columbia, United States
• Howard University — Washington D.C., District of Columbia, United States
• Baumel Eisner Neuromedical Institute — Boca Raton, Florida, United States
• Mayo Clinic (Jacksonville) — Jacksonville, Florida, United States
• Wein Center — Miami Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush Alzheimer's Disease Center, Rush University — Chicago, Illinois, United States
• Indiana University Alzheimer's Center — Indianapolis, Indiana, United States
• University of Kentucky, Sanders-Brown Center on Aging — Lexington, Kentucky, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• University of Michigan at Ann Arbor — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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