Alzheimer Disease Clinical Trial
Official title:
A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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