Expired Study
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Baltimore, Maryland 21287


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.


Study summary:

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.


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


Study is Available At:


Original ID:

IA0026


NCT ID:

NCT00007189


Secondary ID:

U01AG015477


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

70 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Seattle Institute for Biomedical and Clinical Research


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

2625


Enrollment Type:


Overall Contact Information

Official Name:John C Breitner, MD, MPH
Principal Investigator
Professor and Head, Division of Geriatric Psychiatry, University of Washington School of Medicine; a

Study Dates

Start Date:January 2001
Primary Completion Date:May 2007
Primary Completion Type:Actual
Verification Date:October 2016
Last Changed Date:October 18, 2016
First Received Date:December 14, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Naproxen Sodium (Aleve)
Intervention Type:Drug
Name:Celecoxib (Celebrex)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Seattle Institute for Biomedical and Clinical Research
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:17111043
Reference Type:Results Reference
Citation: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.
PMID:17460158
Reference Type:Reference
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.
PMID:8757015
Reference Type:Reference
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.
PMID:8712791
Reference Type:Reference
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.
PMID:10851364

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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