NCT06783465招募中不适用
AI-Driven Generative Content and Precision Dynamic Executive Function Cognitive Digital Therapeutics System for Dementia Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Instrumental Activities of Daily Living (IADL)
研究概览
简要总结
The study would investigate the effect of a cognitive digital therapeutics system. The intervention group would receive three digital therapeutics sessions per week for 8 weeks, while the control group would receive usual care. Evaluations would be done at baseline, week 8, and week 16.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 50 years old.
- •Clinical Dementia Rating from 0.5-1
- •Physician diagnosed mild neurocognitive disorder or dementia (according to ICD-11 diagnostic criteria)
排除标准
- •Mini-mental state examination score below 18
- •If receiving an approved Alzheimer's disease treatment such as acetylcholinesterase inhibitor (AChEIs) or memantine or both for Alzheimer's disease, must be on a stable dose for at least 4 weeks prior to Baseline.
- •Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's mild neurocognitive disorder or dementia.
- •History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
- •Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant.
- •Geriatric Depression Scale (GDS) score greater than or equal to 10 at Screening.
- •Participants who were dosed in a clinical study involving any new chemical entities for AD within 6 months prior to screening unless it can be documented that the participant was in a placebo treatment arm.
结局指标
主要结局
Instrumental Activities of Daily Living (IADL)
时间窗: Baseline, Week 8, Week 16
e.g., K-IADL (Korean Instrumental Activities of Daily Living): range from 0 to 33; Higher scores = worse outcomes, lower scores = better independence.
次要结局
- The Montreal Cognitive Assessment (MoCA)(Baseline, Week 8, Week 16)
- Mini-Mental State Examination score (MMSE)(Baseline, Week 8, Week 16)
- Clinical Dementia Rating score (CDR)(Baseline, Week 8, Week 16)
- Executive Function Performance Test score (EFPT)(Baseline, Week 8, Week 16)
研究者
研究点 (2)
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