Alzheimer's Disease Anti-Inflammatory Prevention Trial

# 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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