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NON-STEROIDAL STUDY - ADCS Clinical Trial (no longer enrolling)

Overview
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. Two drugs were selected for a therapeutic trial: rofecoxib, a new selective cyclooxygenase (COX)-2 inhibitor, and naproxen, a non-selective NSAID.

What is the main objective of this study?
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 diesease as measured by the ADAScog.

What are the secondary objectives of this study?
The other objectives of this study are:
  • To determine whether treatment with rofecoxib or naproxen for one year will slow the rate of clinical deterioration in patients with Alzheimer's disease as measured by the CDR-SOB
  • To determine whether treatment with rofecoxib or naproxen will affect the attainmet of clinically significant endpoints: 4 or 7 point decline from baseline ADAScog, death, institutionalization, one point worsening on the global CDR, or loss of 15 point on the ADCS-ADL scale
  • To determine whether treatment with refecoxib or naproxen for one year will affect other clinical measures of behavior, quality of life and pharmacoeconomics
  • To compare the effect of rofecoxib and naproxen on the rate of cognitive and clinical deterioration in patients with Alzheimer's disease
  • To determine the tolerability of treatment with refecoxib or naproxen in patients with Alzheimer's disease

How will the study be conducted?
The study will be a randomized, double-blind, placebo-controlled, balanced, parallel-group design.

How many patients will be participating in the study?
There will be approximately 350 participants in the study. They will be randomized to three primary treatment groups: rofecoxib (25mg daily), naproxen (200mg twice daily), and placebo.

Who is eligible to participate in this study?
The following are the eligibility criteria for this study:
  • Men and women aged 55 to 90 with Alzheimer's disease.
  • Must have a stable medical condition for at least three months prior to screening
  • An absence of clinically significant focal lesions (demonstrated by a CT or MRI since the onset of memory impairment)
  • Be on stable medication (cholinesterase inhibitors, estrogen, low dose aspirin and vitamin E)
  • A Hachinski score less than or equal to 4
  • Subjects may be using cholinesterase inhibitors if dosage is stable for 3 months.

Who is not eligible to participate in this study?
Patients with the following criteria are ineligible for this study:
  • Hypersensitivity to aspirin or NSAIDS
  • Active peptic ulcer disease within the past five years
  • Renal insufficiency
  • Clinically significant liver disease
  • Poorly controlled hypertension
  • Congestive heart failure
  • Bleeding disorder
  • Active neoplastic disease
  • Inflammatory diseases
  • History of clinically significant stroke

How can I enroll in this study?
The Non-Steroidal study has completed active enrollment of patients.



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