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

This study has been completed.
Sponsor:
Collaborators:
University of Washington
Johns Hopkins University
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00007189
First received: December 14, 2000
Last updated: September 20, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Drug: Naproxen Sodium (Aleve)
Drug: Celecoxib (Celebrex)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 2625
Study Start Date: January 2001
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007189

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00007189     History of Changes
Other Study ID Numbers: IA0026, U01-AG15477
Study First Received: December 14, 2000
Last Updated: September 20, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Alzheimer disease
Anti-inflammatory drugs

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Anti-Inflammatory Agents
Naproxen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014