跳至主要内容
临床试验/NCT01417130
NCT01417130Unknown不适用

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

Seattle Institute for Biomedical and Clinical Research6 个研究点 分布在 1 个国家目标入组 1,650 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,650
试验地点
6
主要终点
Incident Alzheimer's Disease dementia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects must have been enrolled previously in the Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT).

排除标准

  • Individuals not previously enrolled in the ADAPT trial.

结局指标

主要结局

Incident Alzheimer's Disease dementia

时间窗: Up to 9 years.

Incidence

次要结局

  • Trajectory of performance on cognitive tests in relation to ADAPT treatment assignment(Up to 9 years.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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