Alzheimer's Disease Anti-Inflammatory Prevention Trial
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Complete Title of Study
Complete Title of Study
Alzheimer’s Disease Anti-Inflammatory Prevention Trial
Study Acronym (The trial’s abbreviation if there is one)
Study Acronym (The trial’s abbreviation if there is one)
(ADAPT)
Principal Investigator, Co-investigators, and Collaborating Institutions
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
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.)
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
Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Phase III
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Phase I Trials
These are initial studies to determine the metabolism and pharmacologic actions of drugs in humans (what are called PK/PD studies or pharmacokinetic / pharmacodynamic studies), the side effects associated with increasing doses (a dose response curve or dose response relationship), and to gain early evidence of effectiveness; may include healthy participants and/or patients. These are sometimes called a first in man study.
Phase II Trials
Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. Sometimes multiple doses will be studied in these trials to select the appropriate dose for further testing in phase III. These are sometimes called a dose finding study.
Phase III Trials
Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. These are also called pivotal trials.
Phase IV Trials
After the drug has been approved by a regulatory agency, these are post-marketing studies to delineate additional information including the drug’s risks,benefits, and optimal use in a broader group of real world patients.
Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
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)
Study Arms and How They Were Treated (Intervention) (Explanation here)
None reported
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
In a clinical study, participants are often divided into groups.
In interventional studies, participants are prospectively assigned to arms and receive different interventions. Assignment to an arm is typically random. Multiple arms allow the effects of different interventions to be compared. Participants in a control arm may receive no intervention, placebo, or an intervention with a known effect.
In observational studies, a pre-defined population may be observed over time and is termed, a cohort. A cohort consists of individuals with some common characteristic(s), for example, age, place of residence/employment, or medical condition. A cohort is observed over time to determine if the presence or absence of an exposure is associated with a health outcome or condition. Other observational studies may compare those with a condition (cases) to those without a condition (control) and evaluate differences in exposures, treatments, or behaviors. The cases and controls may be selected from a larger population or a cohort.
Source
Primary Pre-Specified Endpoint
Primary Pre-Specified Endpoint
None reported
Secondary Endpoints
Secondary Endpoints
None reported
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 (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
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)
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)
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)
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)
Conclusions of the Investigators (Quote the investigators conclusions here)
None reported
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
None reported
Slides
Slides
None reported
Video Commentary
Video Commentary
None reported
External sites for further information (How to insert links)
External sites for further information (How to insert links)
None reported
Detailed information about the trial
Detailed information about the trial
Ages
Ages
__ years to ___ years
Gender (Indicate whether men, women or both were enrolled)
Gender (Indicate whether men, women or both were enrolled)
None reported
Accepts Healthy Volunteers (Answer yes or no)
Accepts Healthy Volunteers (Answer yes or no)
None reported
Enrollment Period (Study start and end date)
Enrollment Period (Study start and end date)
None reported
Recruitment Status (explanation)
Recruitment Status (explanation)
None reported
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Recruitment status indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:
- Not yet recruiting: participants are not yet being recruited or enrolled
- Recruiting: participants are currently being recruited and enrolled
- Enrolling by invitation: participants are being (or will be) selected from a predetermined population
- Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
- Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient’s last visit has occurred)
- Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
- Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
- Withdrawn: study halted prematurely, prior to enrollment of first participant
Enrollment (Total number of patients enrolled)
Enrollment (Total number of patients enrolled)
None reported
Study Sponsor (e.g. Investigator initiated or company name)
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)
Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
None reported
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