NCT03238001已完成不适用
Evaluation of DCTclock™ as a Cognitive Assessment Aid
Digital Cognition Technologies2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2017年7月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)
研究概览
简要总结
The overall objective of this study is to demonstrate the safety and effectiveness of DCTclock as an adjunctive tool for use by clinicians to evaluate cognitive function in adults aged 55-95.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 55 to 95 years old.
排除标准
- •Ineligible for written informed consent.
- •Physical impairment of the writing hand.
- •Impaired manual dexterity.
- •Impaired vision.
- •Under the influence of recreational drugs or alcohol at the time of the visit.
- •Current or recent participation in a clinical trial that includes the use of a drug or intervention to alter cognitive function.
- •Recent cognitive testing.
研究组 & 干预措施
All qualified participants
Experimental
Participants received DCTclock, Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and a battery of other traditional pen and paper neuropsychological assessments.
干预措施: DCTclock (Device)
结局指标
主要结局
Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)
时间窗: Visit 1 (day 1)
The primary analysis will assess agreement between DCTclock and the Montreal Cognitive Assessment (MoCA) and compare it to the agreement between the MMSE and MoCA at visit 1.
次要结局
- Regression Coefficients on Primary Endpoints(Visit 1 (day 1))
- Percent Agreement on Secondary Endpoints (Test-retest Reliability)(Visit 1 and visit 2, occurring 1-4 weeks apart)
- Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)(Visit 1 and visit 2, occurring 1-4 weeks apart)
- Correlation Coefficients on Primary Endpoints(Visit 1 (day 1))
- Quadratic Weighted Kappa on Primary Endpoints(Visit 1 (day 1))
- Percent Agreement on Primary Endpoints(Visit 1 (day 1))
- Regression Coefficients on Secondary Endpoints (Test-retest Reliability)(Visit 1 and visit 2, occurring 1-4 weeks apart)
- Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)(Visit 1 and visit 2, occurring 1-4 weeks apart)
研究者
研究点 (2)
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