A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)
NCT ID: NCT00004845
Last Updated: 2009-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
INTERVENTIONAL
2001-12-31
Brief Summary
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Detailed Description
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The primary outcome measure will be the one year change in the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAScog). The attainment of significant endpoints will be examined as a secondary outcome measure. Other secondary measures include the CDR sum-of-boxes, Neuropsychiatric Inventory, the Quality of Life-AD and the ADCS pharmacoeconomic scale. The influence of HLA-DR (Human Leukocyte Antigen) genotype on clinical progression and response to treatment will also be examined.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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Rofecoxib
Naproxen
Eligibility Criteria
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Inclusion Criteria
* MMSE between 13 and 26, inclusive
* Stable medical condition for 3 months
* Screening visit
* Physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam, and clinical laboratory tests
* Supervision available for administration of study medications; caregiver/informant to accompany patient to all scheduled visits
* Fluent in English or Spanish
* Age greater than or equal to 55 years old
* Modified Hachinski of less than or equal to 4
* CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion
* Able to complete baseline assessments
* 6 years of education or work history sufficient to exclude mental retardation
* Able to ingest oral medication
Exclusion Criteria
* Active peptic ulcer disease within 5 years
* Renal insufficiency with creatinine greater than 1.5
* Clinically significant liver disease
* Poorly controlled hypertension
* Congestive heart failure
* Bleeding ulcer
* Active neoplastic disease (skin tumors other than melanoma are not exclusionary; patients with stable prostate cancer may be included at the discretion of the project director)
* Inflammatory diseases (including crystal arthropathy, rheumatoid arthritis, systemic lupus, erythematosus, Sjogren's syndrome, inflammatory bowel disease)
55 Years
ALL
No
Sponsors
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Alzheimer's Disease Cooperative Study (ADCS)
OTHER
National Institute on Aging (NIA)
NIH
Principal Investigators
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Leon Thal, MD
Role: PRINCIPAL_INVESTIGATOR
Alzheimer's Disease Cooperative Study
Locations
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Barrow Neurological Group
Phoenix, Arizona, United States
University of Arizona, Tucson
Tucson, Arizona, United States
University of California Irvine Institute for Brain Aging and Dementia
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
University of California, Davis
Martinez, California, United States
Yale University, School of Medicine
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Baumel-Eisner Neuromedical Institute, Boca Raton
Boca Raton, Florida, United States
Baumel-Eisner Ft Lauderdale
Fort Lauderdale, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Wein Center
Miami Beach, Florida, United States
Baumel-Eisner Neuromedical Institute, MiamiBeach
Miami Beach, Florida, United States
University of South Florida
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Kansas University
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nevada
Las Vegas, Nevada, United States
ClinSearch, Inc
Summit, New Jersey, United States
New York University Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Memorial Hospital of Rhode Island
Providence, Rhode Island, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas, SW Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Southwestern Vermont Medical Center
Bennington, Vermont, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Aisen PS, Schafer KA, Grundman M, Pfeiffer E, Sano M, Davis KL, Farlow MR, Jin S, Thomas RG, Thal LJ; Alzheimer's Disease Cooperative Study. Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial. JAMA. 2003 Jun 4;289(21):2819-26. doi: 10.1001/jama.289.21.2819.
Other Identifiers
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IA0021
Identifier Type: -
Identifier Source: org_study_id