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Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00007189
Recruitment Status : Completed
First Posted : December 14, 2000
Last Update Posted : October 19, 2016
Sponsor:
Collaborators:
National Institute on Aging (NIA)
VA Puget Sound Health Care System
University of Washington
Johns Hopkins University
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Tracking Information
First Submitted Date  ICMJE December 14, 2000
First Posted Date  ICMJE December 14, 2000
Last Update Posted Date October 19, 2016
Study Start Date  ICMJE January 2001
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)
Official Title  ICMJE Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)
Brief Summary 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.
Detailed Description

Considerable evidence suggests that inflammation may play a role in the neurodegenerative process of Alzheimer's disease (AD), and the use of non-steroidal anti-inflammatory drugs may be associated with reduced occurrence of AD. ADAPT is a randomized trial that will 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. This long-term trial will run for 5 to 7 years.

The study is sponsored by the National Institute on Aging and is being conducted at the Roskamp Institute in Tampa, FL; the Veterans Affairs Puget Sound Health Care System with the University of Washington, in Seattle, WA; Boston University School of Medicine, in Boston, MA; the Johns Hopkins Medical Institutions, in Baltimore, MD; Sun Health Research Institute, in Phoenix, AZ; and the University of Rochester, in Rochester, NY. At each of these six sites, the goal is the enroll approximately 700 men and women, totalling 2,625 participants. Participants must be 70 years of age or older, have a parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease.

Participants will be asked to take an anti-inflammatory medication or placebo (inactive pill) twice daily. Before enrolling in the trial, participants will be asked to go to a study site for two medical evaluations. Once enrolled, they will need to go to a study site for a medical evaluation every six months and to participate in a telephone interview twice a year for an average of up to seven years of follow-up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: Naproxen Sodium (Aleve)
  • Drug: Celecoxib (Celebrex)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
2625
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00007189
Other Study ID Numbers  ICMJE IA0026
U01AG015477 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Institute for Biomedical and Clinical Research
Study Sponsor  ICMJE Seattle Institute for Biomedical and Clinical Research
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • VA Puget Sound Health Care System
  • University of Washington
  • Johns Hopkins University
Investigators  ICMJE
Principal Investigator: John C Breitner, MD, MPH Professor and Head, Division of Geriatric Psychiatry, University of Washington School of Medicine; and Director, GRCC, VA Puget Sound Health Care System, Seattle
PRS Account Seattle Institute for Biomedical and Clinical Research
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP