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临床试验/NCT01220674
NCT01220674
已完成
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Pilot Testing a New Computer-based Screening Tool to Detect Cognitive Impairment

University of Nebraska1 个研究点 分布在 1 个国家目标入组 152 人2010年12月15日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Cognitive Impairment
发起方
University of Nebraska
入组人数
152
试验地点
1
状态
已完成
最后更新
2年前

概览

简要总结

A computer-based neuropsychological assessment tool is being developed to help primary care physicians detect neurological and psychiatric disorders. The first version will be tested against current tests to confirm the tool's effectiveness. Data will be collected on how well the tool detects disease, how well patients understand the instructions and enjoy performing the tasks, and if particular trials or stimuli are too difficult or too easy for all subjects. Adjustments can then be made to the assessment tool, if needed. The initial participants will be age fifty-five to seventy-five with early dementias or mild cognitive impairment to reduce variability.

详细描述

The investigators are developing a computer-based neuropsychological assessment tool to help primary care physicians detect neurological and psychiatric disorders. To confirm the tool's efficacy, the investigators will first test the prototype against established tests. The investigators propose to collect preliminary data on a limited group of subjects and age-matched controls. Collecting data on a limited group of subjects provides early insight into how well the tool detects disease, how well patients understand the instructions and enjoy performing the tasks, and if particular trials or stimuli are too difficult or too easy for all subjects. With this information, the investigators can make adjustments to the tool if needed and collect additional data on revised versions of the tool. The data will be used to establish the validity, reliability and sensitivity of the tool to generate consistent and accurate scores. The investigators will initially focus on a limited age range (age fifty-five to seventy-five) and limited set of diseases (early dementias or mild cognitive impairment) to reduce variability within the patient and control groups and to gain more statistical power with a smaller group of subjects.

注册库
clinicaltrials.gov
开始日期
2010年12月15日
结束日期
2012年10月31日
最后更新
2年前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Any subject with mild impairment from who has already undergone or will soon undergo a full neuropsychological evaluation.
  • Subjects with Clinical Dementia Rating Scale CDR of 0.5-1.0 and Mini-Mental Score 20-26 (or MOCA equivalent, borderline/mild dementia) will be eligible for this group.
  • Normal controls without exclusion criteria.

排除标准

  • Subjects whose impairment is severe enough to limit their ability to perform the computer-based tasks and/or to provide consent.
  • Subjects with history of learning disabilities or mental illness including major depression, bipolar disorder, anxiety disorders, and addiction are excluded because these problems can affect cognitive performance.

结局指标

主要结局

未指定

研究点 (1)

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