A Single-blind (Data Analyst 1), Single-arm Design, Prospective, Multi-center Confirmatory Clinical Trial for Verifying the Efficacy and Safety of 'ALZGUARD' as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders According to DSM-5
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 3
- 主要终点
- Area Under the Curve (AUC)
研究概览
简要总结
The goal of this clinical trial is to evalute the efficacy of ALZGUARD, a smartphone-based digital therapeutic(DTx), in comparison to diagnosis by medical doctors, as weel as to assess the safety of the application.
详细描述
The study will be conducted across multiple sites, enrolling participants aged 55 to 85 years olds.
The primary objective of the study is to compare the diagnositic accuracy of ALZGAURD against traditional diagnostic evaluactions conducted by medical professionals. The primary endpoint for efficacy will be the Area Under the Curve(AUC), which will measure the diagnostic performance of the application. This statistical metric will help determine how well ALZGUARD can identify dementia compared to standard diagnostic methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
In this study, there will be two data analysts involved. Analyst 1 will be responsible for analyzing the results generated by the ALZGUARD application, which are based on the ALZGUARD AI model. This analyst will assess whether each subject has dementia and the likelihood or probability of the diagnosis. Analyst 1 will be blinded to any clinical assessments or dianoses made by the neurologists.
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
- •Participants must be between 55 and 85 years old (both men and women).
- •Participants must be able to understand and voluntarily agree to the purpose, content, and procedures of the clinical trial.
排除标准
- •Participants with no literacy or illiteracy.
- •Participants with an intellectual disability.
- •Participants with presenting active psychiatric symptoms.
- •Participants who have difficulty ALZGUARD application
- •Participants who are unable to use a smartphone, unless they can use it with assistant.
- •Participants with a history of suicidal ideation or suicidal complusion in the last 6 months.
- •Other conditions as deemed inappropriate for study participant by the Principal Investigator(PI).
研究组 & 干预措施
ALZGUARD Intervention Group
All participants wil use the ALZGAURD smartphone-based digital therapeutic(DTx) to assess cognitive function for detecting dementia.
干预措施: ALZGUARD (Device)
结局指标
主要结局
Area Under the Curve (AUC)
时间窗: up to 8 months
The primary outcome will be the Area Under the Curve (AUC), which will assess the diagnostic accuracy of ALZGUARD by comparing its results with the clinical diagnosis made by neurologists. AUC will be calculated to determine the performance of ALZGUARD in detecting dementia.
次要结局
- Sensitivity(up to 8 months)
- Specificity(up to 8 months)