A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Collaborator: Alzheimer's Disease Cooperative Study (ADCS)
• Treatments: Naproxen; Rofecoxib

Criteria

Inclusion Criteria:

• NINCDS/ADRDA criteria for probable AD

• MMSE between 13 and 26, inclusive

• Stable medical condition for 3 months

• Screening visit

• Physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam, and clinical laboratory tests

• Supervision available for administration of study medications; caregiver/informant to accompany patient to all scheduled visits

• Fluent in English or Spanish

• Age greater than or equal to 55 years old

• Modified Hachinski of less than or equal to 4

• CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion

• Able to complete baseline assessments

• 6 years of education or work history sufficient to exclude mental retardation

• Able to ingest oral medication

Exclusion Criteria:

• Hypersensitivity to aspirin or NSAID

• Active peptic ulcer disease within 5 years

• Renal insufficiency with creatinine greater than 1.5

• Clinically significant liver disease

• Poorly controlled hypertension

• Congestive heart failure

• Bleeding ulcer

• Active neoplastic disease (skin tumors other than melanoma are not exclusionary; patients with stable prostate cancer may be included at the discretion of the project director)

• Inflammatory diseases (including crystal arthropathy, rheumatoid arthritis, systemic lupus, erythematosus, Sjogren's syndrome, inflammatory bowel disease)