A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)
1 other identifier
interventional
N/A
1 country
40
Brief Summary
The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2000
CompletedFirst Posted
Study publicly available on registry
February 29, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2001
CompletedDecember 11, 2009
June 1, 2009
February 28, 2000
December 10, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- NINCDS/ADRDA criteria for probable AD
- 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
- years of education or work history sufficient to exclude mental retardation
- Able to ingest oral medication
You may not qualify if:
- Hypersensitivity to aspirin or NSAID
- 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
- Inflammatory diseases (including crystal arthropathy, rheumatoid arthritis, systemic lupus, erythematosus, Sjogren's syndrome, inflammatory bowel disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Barrow Neurological Group
Phoenix, Arizona, 85013, United States
University of Arizona, Tucson
Tucson, Arizona, 85724-5023, United States
University of California Irvine Institute for Brain Aging and Dementia
Irvine, California, 92697-4285, United States
University of California, San Diego
La Jolla, California, 92037, United States
University of Southern California
Los Angeles, California, 90033-1039, United States
University of California, Los Angeles
Los Angeles, California, 90095-1769, United States
University of California, Davis
Martinez, California, 94553, United States
Yale University, School of Medicine
New Haven, Connecticut, 06520, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Baumel-Eisner Neuromedical Institute, Boca Raton
Boca Raton, Florida, 33486, United States
Baumel-Eisner Ft Lauderdale
Fort Lauderdale, Florida, 33321, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32225, United States
Wein Center
Miami Beach, Florida, 33140, United States
Baumel-Eisner Neuromedical Institute, MiamiBeach
Miami Beach, Florida, 33154, United States
University of South Florida
Tampa, Florida, 33617, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Emory University
Atlanta, Georgia, 30329, United States
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202-5266, United States
Kansas University
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 40536-0230, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University
St Louis, Missouri, 63108-2293, United States
University of Nevada
Las Vegas, Nevada, 89102, United States
ClinSearch, Inc
Summit, New Jersey, 07901, United States
New York University Medical Center
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14620, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44120, United States
Oregon Health Sciences University
Portland, Oregon, 97201-3098, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Memorial Hospital of Rhode Island
Providence, Rhode Island, 02906, United States
Medical University of South Carolina
North Charleston, South Carolina, 29406, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-8646, United States
University of Texas, SW Medical Center
Dallas, Texas, 75390-9070, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Southwestern Vermont Medical Center
Bennington, Vermont, 05201, United States
University of Washington
Seattle, Washington, 98108, United States
Related Publications (1)
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.
PMID: 12783912RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leon Thal, MD
Alzheimer's Disease Cooperative Study
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 28, 2000
First Posted
February 29, 2000
Primary Completion
December 1, 2001
Study Completion
December 1, 2001
Last Updated
December 11, 2009
Record last verified: 2009-06