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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Seattle Institute for Biomedical and Clinical Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
VA Puget Sound Health Care System
Johns Hopkins University
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT01417130
First received: June 24, 2011
Last updated: January 5, 2012
Last verified: January 2012

June 24, 2011
January 5, 2012
August 2009
October 2011   (final data collection date for primary outcome measure)
Incident Alzheimer's Disease dementia [ Time Frame: Up to 9 years. ] [ Designated as safety issue: No ]
Incidence
Same as current
Complete list of historical versions of study NCT01417130 on ClinicalTrials.gov Archive Site
Trajectory of performance on cognitive tests in relation to ADAPT treatment assignment [ Time Frame: Up to 9 years. ] [ Designated as safety issue: No ]
Telephone Interview for Cognitive Status (TICS), Rivermead Behavioral Memory Test (RBMT), Generative Verbal Fluency (GVF)
Same as current
Not Provided
Not Provided
 
Follow-up Study of the Alzheimer's Disease Anti-Inflammatory Prevention Trial
Alzheimer's Disease Anti-Inflammatory Prevention Trial Follow-Up Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

Living members of the cohort previously enrolled in the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT)

  • Alzheimer Disease
  • Dementia
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1650
August 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
75 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01417130
BREITNERBJ18CO, 5U01AG015477-07
No
Seattle Institute for Biomedical and Clinical Research
Seattle Institute for Biomedical and Clinical Research
  • VA Puget Sound Health Care System
  • National Institute on Aging (NIA)
  • Johns Hopkins University
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
Seattle Institute for Biomedical and Clinical Research
January 2012

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