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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007189
• Other study ID #: IA0026
• Secondary ID: U01AG015477
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2000
• Last updated: October 18, 2016
• Start date: January 2001

Study information

• Verified date: October 2016
• Source: Seattle Institute for Biomedical and Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2625
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Naproxen Sodium (Aleve)

• Celecoxib (Celebrex)

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Seattle Institute for Biomedical and Clinical Research	Johns Hopkins University, National Institute on Aging (NIA), University of Washington, VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (5)

ADAPT Research Group, Lyketsos CG, Breitner JC, Green RC, Martin BK, Meinert C, Piantadosi S, Sabbagh M. Naproxen and celecoxib do not prevent AD in early results from a randomized controlled trial. Neurology. 2007 May 22;68(21):1800-8. Epub 2007 Apr 25. — View Citation

ADAPT Research Group. Cardiovascular and cerebrovascular events in the randomized, controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT). PLoS Clin Trials. 2006 Nov 17;1(7):e33. — View Citation

Anthony JC, Breitner JC, Zandi PP, Meyer MR, Jurasova I, Norton MC, Stone SV. Reduced prevalence of AD in users of NSAIDs and H2 receptor antagonists: the Cache County study. Neurology. 2000 Jun 13;54(11):2066-71. — View Citation

Breitner JC. The role of anti-inflammatory drugs in the prevention and treatment of Alzheimer's disease. Annu Rev Med. 1996;47:401-11. Review. — View Citation

McGeer PL, Schulzer M, McGeer EG. Arthritis and anti-inflammatory agents as possible protective factors for Alzheimer's disease: a review of 17 epidemiologic studies. Neurology. 1996 Aug;47(2):425-32. — View Citation

External Links

•   ADAPT Clinical Trial Web Site