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Related Experiment Videos

Rofecoxib: no effect on Alzheimer's disease in a 1-year, randomized, blinded, controlled study.

S A Reines1, G A Block, J C Morris

  • 1Merck Research Laboratories, 10 Sentry Parkway, Blue Bell, PA 19422, USA.

Neurology
|January 14, 2004
PubMed
Summary
This summary is machine-generated.

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Rofecoxib, a cyclo-oxygenase-2 inhibitor, did not slow Alzheimer's disease progression in patients with established dementia. This suggests either the disease is too advanced for intervention or cyclo-oxygenase-2 is not a key factor.

Area of Science:

  • Neuroscience
  • Pharmacology
  • Geriatrics

Background:

  • Inflammatory mechanisms are implicated in Alzheimer's disease (AD) pathogenesis.
  • Cyclo-oxygenase-2 (COX-2) enzyme activity may mediate these inflammatory processes.
  • Selective COX-2 inhibitors are a potential therapeutic target for AD.

Purpose of the Study:

  • To evaluate the efficacy of rofecoxib, a selective COX-2 inhibitor, in slowing dementia progression in patients with established AD.
  • To determine if inhibiting COX-2 can alter the course of Alzheimer's disease.

Main Methods:

  • A 12-month, double-blinded, multicenter trial involving 692 patients with mild to moderate AD.
  • Patients aged 50+ were randomized to receive 25 mg rofecoxib or placebo daily.
  • Efficacy was measured by changes in the AD Assessment Scale cognitive subscale (ADAS-cog) and Clinician's Interview Based Impression of Change (CIBIC+).

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Main Results:

  • No significant differences were observed between rofecoxib and placebo groups on ADAS-cog or CIBIC+ scores after 12 months.
  • Results remained consistent after adjusting for baseline dementia severity, APOE-epsilon4 allele, and donepezil use.
  • Secondary analyses also showed no significant differences across other efficacy measures.

Conclusions:

  • Selective cyclo-oxygenase-2 inhibition failed to demonstrate a benefit in slowing AD progression in patients with established dementia.
  • This outcome may suggest that AD is too advanced for modification by this mechanism in such patients.
  • Alternatively, COX-2 may not play a significant role in the pathogenesis of established Alzheimer's disease.