Alzheimer's Disease Anti-Inflammatory Prevention Trial

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Complete Title of Study
Alzheimer's Disease Anti-Inflammatory Prevention Trial

Study Acronym (The trial's abbreviation if there is one)
(ADAPT)

Principal Investigator, Co-investigators, and Collaborating Institutions
Principal Investigator: John C Breitner, MD, MPH

Sponsors and Collaborators: National Institute on Aging (NIA)and Department of Veterans Affairs

Institutions: University of Washington and Johns Hopkins University

Overview of Trial
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.

Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)
Alzheimer Disease

Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Phase III

Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Study Arms and How They Were Treated (Intervention) (Explanation here)
None reported

Primary Pre-Specified Endpoint
None reported

Secondary Endpoints
None reported

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

Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported

Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported

Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported

Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)
None reported

Conclusions of the Investigators (Quote the investigators conclusions here)
None reported

Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
None reported

Slides
None reported

Video Commentary
None reported

References (How to insert a reference)
None reported

External sites for further information (How to insert links)
None reported

Ages
__ years to ___ years

Gender (Indicate whether men, women or both were enrolled)
None reported

Accepts Healthy Volunteers (Answer yes or no)
None reported

Enrollment Period (Study start and end date)
None reported

Recruitment Status (explanation)
None reported

Enrollment (Total number of patients enrolled)
None reported

Study Sponsor (e.g. Investigator initiated or company name)
None reported (this may not have yet been ascertained)

Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
None reported

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