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

Study Overview
=================
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.

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.

Official Title
-----------------
Alzheimer's Disease Anti-Inflammatory Prevention Trial Follow-Up Study

Conditions
-----------------
Alzheimer Disease, Dementia

Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Naproxen sodium (220 mg b.i.d)<br>Original assignment in the ADAPT trial | |
| Celecoxib (200 mg b.i.d.)<br>Original assignment in the ADAPT trial | |
| Placebo<br>Original assignment in the ADAPT trial | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident Alzheimer's Disease dementia | Incidence | Up to 9 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trajectory of performance on cognitive tests in relation to ADAPT treatment assignment | Telephone Interview for Cognitive Status (TICS), Rivermead Behavioral Memory Test (RBMT), Generative Verbal Fluency (GVF) | Up to 9 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Naproxen, Celecoxib, Anti-Inflammatory Agents, Non-Steroidal