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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00004845 |
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 |
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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.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Leon Thal, MD | Alzheimer's Disease Cooperative Study |
Study ID Numbers: | IA0021 |
Study First Received: | February 28, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004845 History of Changes |
Health Authority: | United States: Federal Government |
Anti-inflammatory |
Anti-Inflammatory Agents Naproxen Cyclooxygenase Inhibitors Alzheimer Disease Central Nervous System Diseases Cyclooxygenase 2 Inhibitors Brain Diseases Neurodegenerative Diseases Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders |
Analgesics, Non-Narcotic Mental Disorders Rofecoxib Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Dementia Delirium |
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 |