A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00004845
- Lead Sponsor
- National Institute on Aging (NIA)
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
University of Southern California
🇺🇸Los Angeles, California, United States
Medical University of South Carolina
🇺🇸North Charleston, South Carolina, United States
University of California Irvine Institute for Brain Aging and Dementia
🇺🇸Irvine, California, United States
University of California, Davis
🇺🇸Martinez, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Rush Presbyterian St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Kansas University
🇺🇸Kansas City, Kansas, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Barrow Neurological Group
🇺🇸Phoenix, Arizona, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Nevada
🇺🇸Las Vegas, Nevada, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
New York University Medical Center
🇺🇸New York, New York, United States
Columbia University
🇺🇸New York, New York, United States
ClinSearch, Inc
🇺🇸Summit, New Jersey, United States
Memorial Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
University of Texas, SW Medical Center
🇺🇸Dallas, Texas, United States
University of Arizona, Tucson
🇺🇸Tucson, Arizona, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
Baumel-Eisner Neuromedical Institute, Boca Raton
🇺🇸Boca Raton, Florida, United States
Baumel-Eisner Neuromedical Institute, MiamiBeach
🇺🇸Miami Beach, Florida, United States
Wein Center
🇺🇸Miami Beach, Florida, United States
Baumel-Eisner Ft Lauderdale
🇺🇸Ft Lauderdale, Florida, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Southwestern Vermont Medical Center
🇺🇸Bennington, Vermont, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Yale University, School of Medicine
🇺🇸New Haven, Connecticut, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States