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

Completed · Phase 2/Phase 3

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT00004845

Run by

National Institute on Aging (NIA)

Expected to finish

2001-12-01

Last updated by the study team

2009-12-11

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Barrow Neurological Group — Phoenix, Arizona, United States
• University of Arizona, Tucson — Tucson, Arizona, United States
• University of California Irvine Institute for Brain Aging and Dementia — Irvine, California, United States
• University of California, San Diego — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, Davis — Martinez, California, United States
• Yale University, School of Medicine — New Haven, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Baumel-Eisner Neuromedical Institute, Boca Raton — Boca Raton, Florida, United States
• Baumel-Eisner Ft Lauderdale — Fort Lauderdale, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Wein Center — Miami Beach, Florida, United States
• Baumel-Eisner Neuromedical Institute, MiamiBeach — Miami Beach, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush Presbyterian St. Luke's Medical Center — Chicago, Illinois, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Kansas University — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• University of Nevada — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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