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.
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.
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)
Barrow Neurological Group, Phoenix, Arizona 85013, United States
University of Arizona, Tucson, Tucson, Arizona 85724-5023, United States
University of California, Davis, Martinez, California 94553, United States
University of California Irvine Institute for Brain Aging and Dementia, Irvine, California 92697-4285, United States
University of California, Los Angeles, Los Angeles, California 90095-1769, United States
University of California, San Diego, La Jolla, California 92037, United States
University of Southern California, Los Angeles, California 90033-1039, United States
Yale University, School of Medicine, New Haven, Connecticut 06520, United States
Georgetown University Medical Center, Washington, District of Columbia 20007, United States
Baumel-Eisner Ft Lauderdale, Ft. Lauderdale, Florida 33321, United States
Baumel-Eisner Neuromedical Institute, Boca Raton, Boca Raton, Florida 33486, United States
Baumel-Eisner Neuromedical Institute, MiamiBeach, Miami Beach, Florida 33154, United States
Mayo Clinic Jacksonville, Jacksonville, Florida 32225, United States
Premiere Research Institute, West Palm Beach, Florida 33407, United States
University of South Florida, Tampa, Florida 33617, United States
Wein Center, Miami Beach, Florida 33140, 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
Columbia University, New York, New York 10032, United States
New York University Medical Center, New York, New York 10016, 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
Baylor College of Medicine, Houston, Texas 77030, United States
University of Texas, SW Medical Center, Dallas, Texas 75390-9070, United States
Southwestern Vermont Medical Center, Bennington, Vermont 05201, United States
University of Washington, Seattle, Washington 98108, United States
