A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)
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|ClinicalTrials.gov Identifier: NCT00004845|
Recruitment Status : Completed
First Posted : February 29, 2000
Last Update Posted : December 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Rofecoxib Drug: Naproxen||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease|
|Primary Completion Date :||December 2001|
|Study Completion Date :||December 2001|
U.S. FDA Resources
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004845
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|Principal Investigator:||Leon Thal, MD||Alzheimer's Disease Cooperative Study|