Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)

The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.

Study Overview

Status

Completed

Conditions

Detailed Description

Considerable evidence suggests that inflammation may play a role in the neurodegenerative process of Alzheimer's disease (AD), and the use of non-steroidal anti-inflammatory drugs may be associated with reduced occurrence of AD. ADAPT is a randomized trial that will test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline. This long-term trial will run for 5 to 7 years.

The study is sponsored by the National Institute on Aging and is being conducted at the Roskamp Institute in Tampa, FL; the Veterans Affairs Puget Sound Health Care System with the University of Washington, in Seattle, WA; Boston University School of Medicine, in Boston, MA; the Johns Hopkins Medical Institutions, in Baltimore, MD; Sun Health Research Institute, in Phoenix, AZ; and the University of Rochester, in Rochester, NY. At each of these six sites, the goal is the enroll approximately 700 men and women, totalling 2,625 participants. Participants must be 70 years of age or older, have a parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease.

Participants will be asked to take an anti-inflammatory medication or placebo (inactive pill) twice daily. Before enrolling in the trial, participants will be asked to go to a study site for two medical evaluations. Once enrolled, they will need to go to a study site for a medical evaluation every six months and to participate in a telephone interview twice a year for an average of up to seven years of follow-up.

Study Type

Interventional

Enrollment

2625

Phase

  • 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

    • Arizona
      • Sun City, Arizona, United States, 85351
        • Sun Health Research Institute
    • Florida
      • Tampa, Florida, United States, 33617
        • Roskamp Institute Memory Clinic, 10770 N. 46th Street
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
    • New York
      • Rochester, New York, United States, 14620
        • University of Rochester
    • Washington
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Puget Sound Health Care System, 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

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 70 years or older.
  • Family history of parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease.
  • Study partner available to provide information on the cognitive status of the participant and to assist with monitoring of trial medications, if needed.
  • Sufficient fluency in written and spoken English to participate in study visits and neuropsychological testing.
  • Willingness to limit use of the following for the duration of the study: vitamin E (at doses greater than 400 IU per day), non-aspirin NSAIDs, histamine H2 receptor antagonists (Tagamet, for example), corticosteroids, anti-inflammatory or analgesic doses of aspirin (greater than 81 mg per day), Ginkgo biloba extracts
  • Ability and intention to participate in regular study visits, in the opinion of the study physician.
  • Provision of informed consent.

Exclusion Criteria:

  • History of peptic ulcer disease with bleeding or obstruction.
  • Clinically significant liver or kidney disease.
  • History of hypersensitivity to aspirin, ibuprofen, celecoxib, naproxen, or other NSAIDs.
  • Use of anti-coagulant medication.
  • Cognitive impairment or dementia.
  • Current alcohol abuse or dependence

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

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

Investigators

  • Principal Investigator: John C Breitner, MD, MPH, Professor and Head, Division of Geriatric Psychiatry, University of Washington School of Medicine; and Director, GRCC, VA Puget Sound Health Care System, Seattle

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

Study Start

January 1, 2001

Primary Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

December 14, 2000

First Submitted That Met QC Criteria

December 13, 2000

First Posted (Estimate)

December 14, 2000

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

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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