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Home > "A" Clinical Trials Conditions > A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study).  A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study).
A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study).
For Condition: Alzheimer Disease
Status: Completed
Sponsor(s): National Institute on Aging (NIA) ,
Synopsis: 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.
Details: Evidence that inflammatory mechanisms contribute to neuronal injury in Alzheimer's disease along with a number of epidemiological studies suggests that non-steroidal anti-inflammatory drugs (NSAIDs) may slow the rate of cognitive deterioration. We have selected two such drugs for a therapeutic trial: rofecoxib and naproxen. The trial employs a double-blind parallel design with three primary treatment groups: rofecoxib, naproxen and placebo. A total of 320 patients will be enrolled in the trial and randomized to the three groups. Stable use of cholinesterase inhibitors, estrogen, low dose aspirin, and vitamin E will be allowed. Patients with inflammatory diseases that might respond to the study medications will be excluded. 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 55 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - 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 - 6 years of education or work history sufficient to exclude mental retardation - Able to ingest oral medication Exclusion Criteria: - 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 - 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonThal, Principal Investigator, Alzheimer's Disease Cooperative Study
University of Minnesota
Minneapolis, Minnesota, 55455
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
University of Arizona, Tucson
Tucson, Arizona, 85724-5023
United States
Washington University
St. Louis, Missouri, 63108-2293
United States
ClinSearch, Inc
Summit, New Jersey, 07901
United States
Premiere Research Institute
West Palm Beach, Florida, 33407
United States
Baumel-Eisner Neuromedical Institute, Boca Raton
Boca Raton, Florida, 33486
United States
University of California, Davis
Martinez, California, 94553
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Southwestern Vermont Medical Center
Bennington, Vermont, 05201
United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United States
Columbia University
New York City, New York, 10032
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Washington
Seattle, Washington, 98108
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-8646
United States
University of California, Los Angeles
Los Angeles, California, 90095-1769
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44120
United States
University of Kentucky
Lexington, Kentucky, 40536-0230
United States
Emory University
Atlanta, Georgia, 30329
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of California, San Diego
La Jolla, California, 92037
United States
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Oregon Health Sciences University
Portland, Oregon, 97201-3098
United States
University of Texas, SW Medical Center
Dallas, Texas, 75390-9070
United States
University of Rochester Medical Center
Rochester, New York, 14620
United States
Kansas University
Kansas City, Kansas, 66160
United States
Medical University of South Carolina
North Charleston, South Carolina, 29406
United States
Memorial Hospital of Rhode Island
Providence, Rhode Island, 02906
United States
University of South Florida
Tampa, Florida, 33617
United States
Baumel-Eisner Neuromedical Institute, MiamiBeach
Miami, Florida, 33154
United States
Wein Center
Miami, Florida, 33140
United States
Barrow Neurological Group
Phoenix, Arizona, 85013
United States
University of Nevada
Las Vegas, Nevada, 89102
United States
Baumel-Eisner Ft Lauderdale
Ft. Lauderdale, Florida, 33321
United States
New York University Medical Center
New York City, New York, 10016
United States
University of California Irvine Institute for Brain Aging and Dementia
Irvine, California, 92697-4285
United States
University of Southern California
Los Angeles, California, 90033-1039
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32225
United States
Yale University, School of Medicine
New Haven, Connecticut, 06520
United States
Indiana University Medical Center
Indianapolis, Indiana, 46202-5266
United States
Additional Information:
Study ID Numbers: IA0021;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004845
Other Alzheimer Disease Studies:
1. Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
2. COGNIShunt® System for Alzheimer's Disease
3. Insulin, Neurogentics and Memory in Alzheimer's Disease
4. Vitamin E in Aging Persons With Down Syndrome
5. Alzheimer's Disease Genetics Study
Related Studies:
Other Alzheimer Disease Clinical Trials
Other Florida Clinical Trials
Other Ft. Lauderdale Clinical Trials
A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study).
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