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Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study Clinical research trials and Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study. Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study clinical trial. Human subjects often get the best healthcare possible for their Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study  Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study
Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study
For Condition: Alzheimer Disease
Status: Recruiting
Sponsor(s): National Institute on Aging (NIA) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
LeonThal, Principal Investigator, University of California, San Diego
University of California, Irvine *Recruiting*
Irvine, California, 92697-7016
United States
Recruiting Catherine McAdams-Ortiz 949-824-8726
University of California, Davis *Recruiting*
Sacramento, California, 95817
United States
Recruiting Barbara Henk 916-734-6750
SUNY Downstate *Recruiting*
Brooklyn, New York, 11203
United States
Recruiting Anne Ganzer 718-270-7319
Yale University, Yale Medical Group *Recruiting*
New Haven, Connecticut, 06511
United States
Recruiting Martha MacAvoy 203-764-8100
University of Rochester *Recruiting*
Rochester, New York, 14642
United States
Recruiting Elizabeth Smith 585-760-6564
University of Washington at Seattle *Recruiting*
Seattle, Washington, 98108
United States
Recruiting Linda Mandelco 206-277-3742
Medical University of South Carolina *Recruiting*
North Charleston, South Carolina, 29406
United States
Recruiting Don Bagwell 843-740-1592
Baylor College of Medicine, Alzheimer's Disease Research Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Jamie Sims 713-798-5325
University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland *Recruiting*
Cleveland, Ohio, 44120
United States
Recruiting Elaine Ziol 800-252-5048
SUNY Stony Brook *Recruiting*
Stony Brook, New York, 11794-8121
United States
Recruiting Dawn Madigan 631-444-8121
University of South Florida *Recruiting*
Tampa, Florida, 33617
United States
Recruiting Regina Velasco 813-974-4355
Washington University, St. Louis School of Medicine *Recruiting*
St. Louis, Missouri, 63108
United States
Recruiting Stacy Stiening 314-286-2477
Mayo Clinic *Recruiting*
Rochester, Minnesota, 55901
United States
Recruiting Mary Botten 507-538-2475
University of Southern California *Recruiting*
Los Angeles, California, 90093
United States
Recruiting Amber Watts 323-442-3715
Rush Alzheimer's Disease Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Raj Shah 312-942-8264
McGowin Center for Neuroscience *Recruiting*
Gulfport, Mississippi, 39500
United States
Recruiting Tracey Henry 228-896-8992
University of Texas, Southwestern Medical School *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Carol Moore 214-648-7468
Boston University School of Medicine *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Jane Mwicigi 617-638-5670
University of Pennsylvania School of Medicine, Alzheimer's Disease Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Kris Gravanda 215-349-5908
University of California, San Diego *Recruiting*
La Jolla, California, 92093-0948
United States
Recruiting Susan Johnson 858-622-5820
Brigham and Women's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Kara Campobasso 617-732-7992
University of Kentucky, Sanders-Brown Center on Aging *Recruiting*
Lexington, Kentucky, 40536-0230
United States
Recruiting Marie Smart 859-258-6601
Stanford University *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Lisa Kinoshita 650-493-0571
Howard University *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Abayomi Adediran 202-865-3776
Emory University *Recruiting*
Atlanta, Georgia, 30329
United States
Recruiting Janet Cellar 404-728-6453
Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Catherine Platt 312-695-2343
Oregon Health and Sciences University *Recruiting*
Portland, Oregon, 97201
United States
Recruiting Joyce Lear 503-494-7615
University of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Carolyn Rickard 412-692-2707
Mount Sinai School of Medicine *Recruiting*
New York City, New York, 10029
United States
Recruiting Jessica Stern 212-241-0438
University of Michigan at Ann Arbor *Recruiting*
Ann Arbor, Michigan, 48109-0504
United States
Recruiting Joanne Lord 734-615-3041
Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Audrey Bauzo 212-305-2077
Memorial Hospital of Rhode Island/Brown University *Recruiting*
Pawtucket, Rhode Island, 02860
United States
Recruiting Susan Lincoln 401-793-2975
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting Michelle McCart 919-416-5387
Southwestern Vermont Medical Center *Recruiting*
Bennington, Vermont, 05201
United States
Recruiting Betty Hathaway 802-447-1409
Barrow Neurology Group *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting Marci Zomok 602-406-6267
University of California, Los Angeles *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Brad Hutchinson 310-825-8908
University of Arizona *Recruiting*
Tucson, Arizona, 85724-5023
United States
Recruiting Margie Baldwin 520-626-7274
University of Alabama, Birmingham *Recruiting*
Birmingham, Alabama, 35294-0017
United States
Recruiting JoAnn Parrish 205-934-6223
Indiana University Alzheimer's Center *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Martha Mendez 317-278-9773
Mayo Clinic (Jacksonville) *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Francine Parfitt 904-953-7103
New York University School Of Medicine *Recruiting*
New York City, New York, 10016
United States
Recruiting Robin Waters
Georgetown University, Memory Disorder Program *Recruiting*
Washington D.C., District of Columbia, 20057
United States
Recruiting Carolyn Ward 202-784-6671
Additional Information:
Study ID Numbers: IA0038;
Study Start Date: December 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053599
Other Alzheimer Disease Studies:
1. Effectiveness of A Nutritional Brain Metabolic Enhancer for Alzheimer Disease
2. The Depression in Alzheimer's Disease Study (DIADS)
3. ALADDIN Study
4. Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study
5. A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study).
Related Studies:
Other Alzheimer Disease Clinical Trials
Other California Clinical Trials
Other Palo Alto Clinical Trials
Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study
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