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

Alzheimer Disease Clinical Trial

Official title:

A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004845
• Other study ID #: IA0021
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 28, 2000
• Last updated: December 10, 2009
• Est. completion date: December 2001

Study information

• Verified date: June 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Rofecoxib

• Naproxen

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Southwestern Vermont Medical Center	Bennington	Vermont
United States	Baumel-Eisner Neuromedical Institute, Boca Raton	Boca Raton	Florida
United States	Rush Presbyterian St. Luke's Medical Center	Chicago	Illinois
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	University of Texas, SW Medical Center	Dallas	Texas
United States	Baumel-Eisner Ft Lauderdale	Ft Lauderdale	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	University of California Irvine Institute for Brain Aging and Dementia	Irvine	California
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Kansas University	Kansas City	Kansas
United States	University of California, San Diego	La Jolla	California
United States	University of Nevada	Las Vegas	Nevada
United States	University of Kentucky	Lexington	Kentucky
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	University of California, Davis	Martinez	California
United States	Baumel-Eisner Neuromedical Institute, MiamiBeach	Miami Beach	Florida
United States	Wein Center	Miami Beach	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University, School of Medicine	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	New York University Medical Center	New York	New York
United States	Medical University of South Carolina	North Charleston	South Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Barrow Neurological Group	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	Memorial Hospital of Rhode Island	Providence	Rhode Island
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Washington	Seattle	Washington
United States	Washington University	St. Louis	Missouri
United States	ClinSearch, Inc	Summit	New Jersey
United States	University of South Florida	Tampa	Florida
United States	University of Arizona, Tucson	Tucson	Arizona
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Premiere Research Institute	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)	Alzheimer's Disease Cooperative Study (ADCS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Aisen PS, Schafer KA, Grundman M, Pfeiffer E, Sano M, Davis KL, Farlow MR, Jin S, Thomas RG, Thal LJ; Alzheimer's Disease Cooperative Study. Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial. JAMA. — View Citation