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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Collaborator: |
Alzheimer's Disease Cooperative Study (ADCS) |
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00004845 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: Rofecoxib Drug: Naproxen |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease |
| Estimated Study Completion Date: | December 2001 |
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| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Barrow Neurological Group | |
| Phoenix, Arizona, United States, 85013 | |
| University of Arizona, Tucson | |
| Tucson, Arizona, United States, 85724-5023 | |
| United States, California | |
| University of California, Davis | |
| Martinez, California, United States, 94553 | |
| University of California Irvine Institute for Brain Aging and Dementia | |
| Irvine, California, United States, 92697-4285 | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 90095-1769 | |
| University of California, San Diego | |
| La Jolla, California, United States, 92037 | |
| University of Southern California | |
| Los Angeles, California, United States, 90033-1039 | |
| United States, Connecticut | |
| Yale University, School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, District of Columbia | |
| Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Baumel-Eisner Ft Lauderdale | |
| Ft Lauderdale, Florida, United States, 33321 | |
| Baumel-Eisner Neuromedical Institute, Boca Raton | |
| Boca Raton, Florida, United States, 33486 | |
| Baumel-Eisner Neuromedical Institute, MiamiBeach | |
| Miami Beach, Florida, United States, 33154 | |
| Mayo Clinic Jacksonville | |
| Jacksonville, Florida, United States, 32225 | |
| Premiere Research Institute | |
| West Palm Beach, Florida, United States, 33407 | |
| University of South Florida | |
| Tampa, Florida, United States, 33617 | |
| Wein Center | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30329 | |
| United States, Illinois | |
| Rush Presbyterian St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana University Medical Center | |
| Indianapolis, Indiana, United States, 46202-5266 | |
| United States, Kansas | |
| Kansas University | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0230 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63108-2293 | |
| United States, Nevada | |
| University of Nevada | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| ClinSearch, Inc | |
| Summit, New Jersey, United States, 07901 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| New York University Medical Center | |
| New York, New York, United States, 10016 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14620 | |
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44120 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201-3098 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Memorial Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| North Charleston, South Carolina, United States, 29406 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37212-8646 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| University of Texas, SW Medical Center | |
| Dallas, Texas, United States, 75390-9070 | |
| United States, Vermont | |
| Southwestern Vermont Medical Center | |
| Bennington, Vermont, United States, 05201 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98108 | |
| Principal Investigator: | Leon Thal, MD | Alzheimer's Disease Cooperative Study |
More Information
| Study ID Numbers: | IA0021 |
| Study First Received: | February 28, 2000 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004845 History of Changes |
| Health Authority: | United States: Federal Government |
|
Anti-inflammatory |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase 2 Inhibitors Neurodegenerative Diseases Brain Diseases Gout Suppressants Mental Disorders Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Dementia Naproxen |
Nervous System Diseases Alzheimer Disease Cyclooxygenase Inhibitors Central Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Analgesics, Non-Narcotic Rofecoxib Peripheral Nervous System Agents Tauopathies Antirheumatic Agents Central Nervous System Agents |
