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

This study has been completed.

Sponsor:

Collaborators:

Department of Veterans Affairs

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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 14, 2000

Last Updated Date

September 20, 2007

Start Date ^ICMJE

January 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00007189 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

Alzheimer Disease

Intervention ^ICMJE

Drug: Naproxen Sodium (Aleve)
Drug: Celecoxib (Celebrex)

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2625

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

70 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00007189

Other Study ID Numbers ^ICMJE

IA0026, U01-AG15477

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute on Aging (NIA)

Collaborators ^ICMJE

Department of Veterans Affairs
University of Washington
Johns Hopkins University

Investigators ^ICMJE

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

Information Provided By

National Institute on Aging (NIA)

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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