Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)
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ClinicalTrials.gov Identifier: NCT00007189 |
Recruitment Status :
Completed
First Posted : December 14, 2000
Last Update Posted : October 19, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Drug: Naproxen Sodium (Aleve) Drug: Celecoxib (Celebrex) | Phase 3 |
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 (Clinical Trial) |
Enrollment : | 2625 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) |
Study Start Date : | January 2001 |
Actual Primary Completion Date : | May 2007 |


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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007189
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 |
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 of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Seattle Institute for Biomedical and Clinical Research |
ClinicalTrials.gov Identifier: | NCT00007189 |
Other Study ID Numbers: |
IA0026 U01AG015477 ( U.S. NIH Grant/Contract ) |
First Posted: | December 14, 2000 Key Record Dates |
Last Update Posted: | October 19, 2016 |
Last Verified: | October 2016 |
Alzheimer disease Anti-inflammatory drugs |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Celecoxib Naproxen Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Gout Suppressants |