View source for Alzheimer's Disease Anti-Inflammatory Prevention Trial

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

==Study Acronym <small>(The trial's abbreviation if there is one) </small>==
(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 <small>(e.g. acute MI, breast cancer, etc.)</small>==
Alzheimer Disease

==Study Phase <small>(e.g. Phase I,II,III,IV) [[Study phase|Study Phases are defined here]]</small>==
Phase III

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

== Study Arms and How They Were Treated (Intervention) <small>[[Study arms|(Explanation here)]]</small>==
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 <small>(Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)</small>==
None reported

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

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

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

==Conclusions of the Investigators <small>(Quote the investigators conclusions here)</small>==
None reported

==Commentary, Discussion and Limitations of the Trial<small> (Anyone can add comments)</small>==
None reported

==Slides==
None reported

==Video Commentary==
None reported

== References [[Help:Adding_References_to_Articles|(How to insert a reference)]]==
None reported

==External sites for further information <small>[[Help:Links|(How to insert links)]]</small>==
None reported

==Detailed information about the trial==
==Ages==
__ years to ___ years 

==Gender <small>(Indicate whether men, women or both were enrolled)</small>==
None reported

==Accepts Healthy Volunteers <small>(Answer yes or no)</small>==
None reported

==Enrollment Period <small>(Study start and end date)</small>==
None reported

==Recruitment Status [[Recruitment status|(explanation)]]==
None reported

==Enrollment <small>(Total number of patients enrolled)</small>==
None reported

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

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


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