We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01417130
Recruitment Status : Unknown
Verified January 2012 by Seattle Institute for Biomedical and Clinical Research.
Recruitment status was:  Active, not recruiting
First Posted : August 16, 2011
Last Update Posted : January 9, 2012
Sponsor:
Collaborators:
VA Puget Sound Health Care System
National Institute on Aging (NIA)
Johns Hopkins University
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Alzheimer Disease Dementia

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alzheimer's Disease Anti-Inflammatory Prevention Trial Follow-Up Study
Study Start Date : August 2009
Actual Primary Completion Date : October 2011
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incident Alzheimer's Disease dementia [ Time Frame: Up to 9 years. ]
    Incidence


Secondary Outcome Measures :
  1. Trajectory of performance on cognitive tests in relation to ADAPT treatment assignment [ Time Frame: Up to 9 years. ]
    Telephone Interview for Cognitive Status (TICS), Rivermead Behavioral Memory Test (RBMT), Generative Verbal Fluency (GVF)


Biospecimen Retention:   Samples With DNA
Specimens retained from the ADAPT trial include plasma, serum, urine and cerebrospinal fluid (the latter from a smaller sample of volunteers). Additional collection of cerebrospinal fluid from prior donors and from a new panel of volunteers is conducted under a different sub-study of ADAPT.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Living members of the cohort previously enrolled in the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT)
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417130


Locations
Layout table for location information
United States, Arizona
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, Florida
The Roskamp Institute
Sarasota, Florida, United States, 34243
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, New York
Monroe Community Hospital
Rochester, New York, United States, 14620
United States, Washington
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
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT01417130    
Other Study ID Numbers: BREITNERBJ18CO
5U01AG015477-07 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: January 9, 2012
Last Verified: January 2012
Keywords provided by Seattle Institute for Biomedical and Clinical Research:
Naproxen
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders