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

December 10, 2009 updated by: National Institute on Aging (NIA)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Group
      • Tucson, Arizona, United States, 85724-5023
        • University of Arizona, Tucson
    • California
      • Irvine, California, United States, 92697-4285
        • University of California Irvine Institute for Brain Aging and Dementia
      • La Jolla, California, United States, 92037
        • University of California, San Diego
      • Los Angeles, California, United States, 90033-1039
        • University of Southern California
      • Los Angeles, California, United States, 90095-1769
        • University of California, Los Angeles
      • Martinez, California, United States, 94553
        • University of California, Davis
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University, School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Baumel-Eisner Neuromedical Institute, Boca Raton
      • Ft Lauderdale, Florida, United States, 33321
        • Baumel-Eisner Ft Lauderdale
      • Jacksonville, Florida, United States, 32225
        • Mayo Clinic Jacksonville
      • Miami Beach, Florida, United States, 33140
        • Wein Center
      • Miami Beach, Florida, United States, 33154
        • Baumel-Eisner Neuromedical Institute, MiamiBeach
      • Tampa, Florida, United States, 33617
        • University of South Florida
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian St. Luke's Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5266
        • Indiana University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0230
        • University of Kentucky
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University Of Minnesota
    • Missouri
      • St. Louis, Missouri, United States, 63108-2293
        • Washington University
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University of Nevada
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • ClinSearch, Inc
    • New York
      • New York, New York, United States, 10016
        • New York University Medical Center
      • New York, New York, United States, 10032
        • Columbia University
      • Rochester, New York, United States, 14620
        • University of Rochester Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44120
        • University Hospitals of Cleveland
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Oregon Health Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Memorial Hospital of Rhode Island
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37212-8646
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390-9070
        • University of Texas, SW Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Southwestern Vermont Medical Center
    • Washington
      • Seattle, Washington, United States, 98108
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Collaborators

Alzheimer's Disease Cooperative Study (ADCS)

Investigators

  • Principal Investigator: Leon Thal, MD, Alzheimer's Disease Cooperative Study

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

December 1, 2001

Study Registration Dates

First Submitted

February 28, 2000

First Submitted That Met QC Criteria

February 28, 2000

First Posted (Estimate)

February 29, 2000

Study Record Updates

Last Update Posted (Estimate)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 10, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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