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	Treatment or Intervention	Phase
Alzheimer Disease	Drug: Simvastatin	Phase III

Further Study Details: 

Expected Total Enrollment:  400

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.

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

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.

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

Study chairs or principal investigators

Mary Sano, PhD,  Principal Investigator,  Mount Sinai Medical Center   
Leon J. Thal, MD,  Principal Investigator,  University of California, San Diego   

Study ID Numbers:  IA0038; ADC-015-LL
Record last reviewed:  March 2005
Last Updated:  March 28, 2005
Record first received:  February 3, 2003
ClinicalTrials.gov Identifier:  NCT00053599
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08