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临床试验/NCT04800588
NCT04800588招募中不适用

Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

Neurobehavioral Systems, Inc.2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
2
主要终点
Longitudinal normative data collection from healthy participants

研究概览

简要总结

The investigators will study performance on computerized cognitive tasks in healthy participants of different ages to gather normative data for newly developed computerized cognitive tests. These tests are designed to permit the early detection of individuals at risk of age-related cognitive decline.

详细描述

In Group A, the investigators will evaluate the performance of healthy older participants (N = 300, age range 60 to 89 years) for three days at enrollment and then at 6-month intervals for three years thereafter. The goal is to characterize changes in performance to aging and task experience in a group of older subjects.

In Group B, the investigators will compare the performance of normal participants (N = 100, age range 18 to 89) on computerized and manually administered cognitive tasks.

In Group C, the investigators will gather normative data from participants across the age range (N = 100, ages 18 to 89) for three days at enrollment, to better characterize test-retest reliability scores on Day 1 tasks.

In Group D, the investigators will evaluate the performance of healthy older participants (N = 1200, age range 60 to 89 years) for three days at enrollment and then at 6-month intervals for three years thereafter. In the aim of better understanding health disparities in cognitive testing, this group will be divided into four cohorts: 300 African American participants; 300 Asian American participants; 300 Latino English-speaking participants; and 300 Latino Spanish-speaking participants, who will complete a Spanish translation of our computerized cognitive tests.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be able to use computer mouse and touch screen
  • Must speak English as a primary language
  • Must speak Spanish as a primary language (for Latino participants completing our Spanish translation)

排除标准

  • History of psychiatric disorder
  • History of stroke or transient ischemic attack
  • History of substance abuse
  • History of medical or sensory disorders that are incompatible with effective testing
  • History of traumatic brain injury with hospitalization and extended loss of consciousness
  • History of epilepsy
  • History of depression or anxiety

结局指标

主要结局

Longitudinal normative data collection from healthy participants

时间窗: Longitudinal testing at six-month intervals

Multiple behavioral outcome measures will be obtained from each cognitive test including measures of response time (in milliseconds) and accuracy (in percent correct). Recordings of subject's verbal responses will also be analyzed phonologically and automatically transcribed to permit the lexical, syntactic, and semantic analysis of speech output. Questionnaire data will be used to identify factors that may influence performance on the cognitive tests. The primary outcome measures are the scores obtained during enrollment testing that predict a decline in longitudinal performance.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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