Overview

This trial is active, not recruiting.

Conditions alzheimer disease, dementia
Sponsor Seattle Institute for Biomedical and Clinical Research
Collaborator VA Puget Sound Health Care System
Start date August 2009
End date October 2011
Trial size 1650 participants
Trial identifier NCT01417130, 5U01AG015477-07, BREITNERBJ18CO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Original assignment in the ADAPT trial
Original assignment in the ADAPT trial
Original assignment in the ADAPT trial

Primary Outcomes

Measure
Incident Alzheimer's Disease dementia
time frame: Up to 9 years.

Secondary Outcomes

Measure
Trajectory of performance on cognitive tests in relation to ADAPT treatment assignment
time frame: Up to 9 years.

Eligibility Criteria

Male or female participants at least 75 years old.

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.

Additional Information

Official title Alzheimer's Disease Anti-Inflammatory Prevention Trial Follow-Up Study
Principal investigator Constantine Lyketsos, MD, MHS
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Seattle Institute for Biomedical and Clinical Research.