NCT05634161进行中（未招募）不适用
Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Usability: Based on scenarios
研究概览
简要总结
Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female patients, 55~85 years
- •Adequate vision, hearing and speaking for neuropsychological testing
- •No difficulty in using mobile application using smartphone
- •Patients with subjective memory complaints, confirmed by informants
- •Cognitive impairment of SD 1 or greater from the age-adjusted normal range in Memory domain in CERAD-NP battery
- •Global CDR 0.5 ~ 1
- •Korean speaker
- •Have an identified trial partner
- •All subjects signed written consent
排除标准
- •Those unable to provide consent
- •History of transient ischemic attack, stroke, brain tumor
- •History of diagnosis of major depression
- •Symptoms that may interfere with the subject's testing procedure
- •Cerebral hemorrhage
- •Central nervous system infections
- •Prohibited concomitant medication
- •Known or suspected history of drug or alcohol abuse
结局指标
主要结局
Usability: Based on scenarios
时间窗: Single-point evaluation (baseline)
次要结局
- Changes in ADCS-ADL(After 12 weeks of system usage)
- Changes in blood biomarker(After 12 weeks of system usage)
- Changes in self-reported quality of life(After 12 weeks of system usage)
- Changes in Adas-cog(After 12 weeks of system usage)
- Usability: Based on user survey(Single-point evaluation (baseline))
- Usability: Based on hemodynamic responses(Single-point evaluation (baseline))
研究者
Jun Young Lee
Professor
Seoul National University Boramae Hospital
研究点 (1)
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