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
  Purpose

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
Alzheimer Disease
Dementia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alzheimer's Disease Anti-Inflammatory Prevention Trial Follow-Up Study

Resource links provided by NLM:


Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • Incident Alzheimer's Disease dementia [ Time Frame: Up to 9 years. ] [ Designated as safety issue: No ]
    Incidence


Secondary Outcome Measures:
  • 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)


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.


Estimated Enrollment: 1650
Study Start Date: August 2009
Estimated Study Completion Date: August 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417130

Locations
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
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
  More Information

Additional Information:
Publications:

Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT01417130     History of Changes
Other Study ID Numbers: BREITNERBJ18CO, 5U01AG015477-07
Study First Received: June 24, 2011
Last Updated: January 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
Naproxen
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 28, 2014