ADAPT-FS: Follow-up Study of the Alzheimer's Disease Anti-Inflammatory Prevention Trial

Sponsor
Seattle Institute for Biomedical and Clinical Research (Other)
Overall Status
Unknown status
CT.gov ID
NCT01417130
Collaborator
VA Puget Sound Health Care System (U.S. Fed), National Institute on Aging (NIA) (NIH), Johns Hopkins University (Other)
1,650
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Study Details

Study Description

Brief Summary

The Alzheimer's Disease Anti-inflammatory Prevention Trial - Follow-up Study (ADAPT-FS) will continue observations of the declared primary outcomes of the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) in the cohort previously established for that trial.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    ADAPT was a multicenter, randomized, placebo-controlled trial designed to test the safety and efficacy of naproxen and celecoxib for the primary prevention of Alzheimer's Disease (AD) dementia and for attenuation of age related cognitive decline in persons over 70 years of age. The ADAPT treatments were stopped on 17 December, 2004, after the substantial majority of participants had been given treatments over an interval of one to three years. Participants remained under observation until May, 2006, using double-masked methods of case identification that were identical to those of the original ADAPT protocol. Results from the entire period of observations in ADAPT were ambiguous and suggested a need for additional longitudinal data to learn whether the dual-inhibitor NSAID naproxen can effect a long-term reduction in the occurrence of AD dementia.

    This ADAPT Follow-up Study (ADAPT-FS) is following-up the participants originally enrolled in ADAPT after a further interval of four years, thereby identifying additional individuals with AD dementia in each treatment assignment group, and then using time-dependent methods to estimate and contrast incidence rates by treatment assignment. The study is also extending prior observations on trajectory of cognitive performance on several psychometric measures, thus testing the hypothesis of differences in such trajectory by treatment assignment in ADAPT.

    ADAPT-FS is sponsored by the National Institute on Aging (NIA) and is being conducted at the Roskamp Institute in Tampa, FL; the Veterans Affairs Puget Sound Health Care System 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1650 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Alzheimer's Disease Anti-Inflammatory Prevention Trial Follow-Up Study
    Study Start Date :
    Aug 1, 2009
    Actual Primary Completion Date :
    Oct 1, 2011
    Anticipated Study Completion Date :
    Aug 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Naproxen sodium (220 mg b.i.d)

    Original assignment in the ADAPT trial

    Celecoxib (200 mg b.i.d.)

    Original assignment in the ADAPT trial

    Placebo

    Original assignment in the ADAPT trial

    Outcome Measures

    Primary Outcome Measures

    1. Incident Alzheimer's Disease dementia [Up to 9 years.]

      Incidence

    Secondary Outcome Measures

    1. Trajectory of performance on cognitive tests in relation to ADAPT treatment assignment [Up to 9 years.]

      Telephone Interview for Cognitive Status (TICS), Rivermead Behavioral Memory Test (RBMT), Generative Verbal Fluency (GVF)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects must have been enrolled previously in the Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT).
    Exclusion Criteria:
    • Individuals not previously enrolled in the ADAPT trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner Sun Health Research Institute Sun City Arizona United States 85351
    2 The Roskamp Institute Sarasota Florida United States 34243
    3 The Johns Hopkins University Baltimore Maryland United States 21205
    4 Boston University School of Medicine Boston Massachusetts United States 02118
    5 Monroe Community Hospital Rochester New York United States 14620
    6 Veterans Affairs Puget Sound Health Care System Seattle Washington United States 98108

    Sponsors and Collaborators

    • Seattle Institute for Biomedical and Clinical Research
    • VA Puget Sound Health Care System
    • National Institute on Aging (NIA)
    • Johns Hopkins University

    Investigators

    • Study Chair: John CS Breitner, MD, MPH, Veteran Affairs Puget Sound Health Care System
    • Study Director: Laura D Baker, PhD, Veteran Affairs Puget Sound Health Care System
    • Principal Investigator: Constantine Lyketsos, MD, MHS, The Johns Hopkins University
    • Principal Investigator: Peter Zandi, PhD, The Johns Hopkins University
    • Principal Investigator: Denis Evans, MD, Rush Institute for Healthy Aging

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Seattle Institute for Biomedical and Clinical Research
    ClinicalTrials.gov Identifier:
    NCT01417130
    Other Study ID Numbers:
    • BREITNERBJ18CO
    • 5U01AG015477-07
    First Posted:
    Aug 16, 2011
    Last Update Posted:
    Jan 9, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Seattle Institute for Biomedical and Clinical Research
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 9, 2012