Alzheimer's Disease Anti-Inflammatory Prevention Trial: Difference between revisions
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==Disease State(s) Studied <small>(e.g. acute MI, breast cancer, etc.)</small>== | ==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>== | ==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>== | ==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>== | == Study Arms and How They Were Treated (Intervention) <small>[[Study arms|(Explanation here)]]</small>== | ||
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== Inclusion 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== | ==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>== | ==Outcome: Primary endpoint <small>(Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)</small>== | ||
Latest revision as of 15:08, 11 June 2009
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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
Detailed information about the trial
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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