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CompletedNCT00007189Updated Oct 19, 2016

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

A Phase 3 interventional study of Naproxen Sodium (Aleve) and Celecoxib (Celebrex) in Alzheimer Disease, sponsored by Seattle Institute for Biomedical and Clinical Research. Completed at 6 sites in United States. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-19.

Sponsored by Seattle Institute for Biomedical and Clinical Research · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,625
Allocation
Randomized
Ages
70 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Alzheimer Disease

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Keywords

  • Alzheimer disease
  • Anti-inflammatory drugs
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In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 2,625 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Seattle Institute for Biomedical and Clinical Research is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
2,625 participants

Interventions

  • DrugNaproxen Sodium (Aleve)
  • DrugCelecoxib (Celebrex)
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Study locations

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

Publications

  • 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. doi: 10.1212/wnl.54.11.2066. PubMed 10851364 ↗
  • Breitner JC. The role of anti-inflammatory drugs in the prevention and treatment of Alzheimer's disease. Annu Rev Med. 1996;47:401-11. doi: 10.1146/annurev.med.47.1.401. PubMed 8712791 ↗
  • 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. doi: 10.1212/wnl.47.2.425. PubMed 8757015 ↗
  • 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. doi: 10.1212/01.wnl.0000260269.93245.d2. Epub 2007 Apr 25. PubMed 17460158 ↗
  • 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. doi: 10.1371/journal.pctr.0010033. PubMed 17111043 ↗
  • Drye LT, Casper AS, Sternberg AL, Holbrook JT, Jenkins G, Meinert CL. The transitioning from trials to extended follow-up studies. Clin Trials. 2014 Dec;11(6):635-47. doi: 10.1177/1740774514547396. Epub 2014 Aug 12. PubMed 25115882 ↗
  • ADAPT-FS Research Group. Follow-up evaluation of cognitive function in the randomized Alzheimer's Disease Anti-inflammatory Prevention Trial and its Follow-up Study. Alzheimers Dement. 2015 Feb;11(2):216-25.e1. doi: 10.1016/j.jalz.2014.03.009. Epub 2014 Jul 9. PubMed 25022541 ↗
  • ADAPT Research Group; Martin BK, Szekely C, Brandt J, Piantadosi S, Breitner JC, Craft S, Evans D, Green R, Mullan M. Cognitive function over time in the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT): results of a randomized, controlled trial of naproxen and celecoxib. Arch Neurol. 2008 Jul;65(7):896-905. doi: 10.1001/archneur.2008.65.7.nct70006. Epub 2008 May 12. PubMed 18474729 ↗
  • Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31. PubMed 18378608 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00007189
Lead sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
National Institute on Aging (NIA), VA Puget Sound Health Care System, University of Washington, Johns Hopkins University
Responsible party
Sponsor
First posted
Dec 14, 2000
Start date
Jan 2001
Primary completion
May 2007
Last update
Oct 19, 2016

Study contacts

John C Breitner, MD, MPH
principal investigator · Professor and Head, Division of Geriatric Psychiatry, University of Washington School of Medicine; and Director, GRCC, VA Puget Sound Health Care System, Seattle
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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