Speech-derived Digital Biomarkers for Assessing Mild Cognitive Impairment and Alzheimer's Disease Diagnosis Accuracy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to assess the sensitivity biomarkers in patients with MCI and AD diagnosis
研究概览
简要总结
The goal is to assess the accuracy of an application that analyzes voice characteristics to diagnose patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD). The main question is whether the application's diagnosis is the same as the clinician's for MCI and AD patients.
详细描述
The study aims to assess the sensitivity and specificity of an application that uses vocal biomarkers to diagnose patients with mild cognitive impairment (MCI) and Alzheimer's disease. The application will use clinically validated survey instruments and voice recordings to determine the disease status of patients with MCI and Alzheimer's disease. The diagnosis developed by the application is the primary outcome variable. To determine the sensitivity and specificity, the application diagnosis will be compared against the physician's clinical diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Males and females between the ages of 50 and above
- •Willing and capable of participating in all aspects of the study
- •Willing and capable of giving informed consent
- •Diagnosis of MCI or Alzheimer's by the physician
- •For the control group: Without diagnosis of MCI or Alzheimer's or other types of dementia
- •Subjects are free of any medical condition(s) that, according to
排除标准
- •, might audibly affect voice characteristics
- •Subject must be able to speak and read with fluency in the English language.
- •Exclusion Criteria:
- •All participants below 50 years
- •Failure to provide informed consent
- •Individuals with the following medical conditions will be excluded:
- •i) Parkinson's disease ii) Huntington's disease iii) Cancer and active cancer treatments
- •Persons with speech characteristics (heavy accents, slurring, stuttering, etc.) that would interfere with voice recording or voice analysis
研究组 & 干预措施
Healthy Volunteers
Patients without a diagnosis of MCI or Alzheimer's, or other types of dementia
干预措施: The Canary Application (Other)
Mild Cognitive Impairment (MCI)
Patients with a mild congitive impairment
干预措施: The Canary Application (Other)
Alzheimer's Disease
Patients with an Alzheimer's Disease diagnosis
干预措施: The Canary Application (Other)
结局指标
主要结局
The primary objective of the study is to assess the sensitivity biomarkers in patients with MCI and AD diagnosis
时间窗: Upon enrollment
The CANARY application will use clinically validated survey instruments and voice recordings to analyze the data and determine the patient's MCI/ Alzheimer's disease diagnosis. The diagnosis developed by the application is the primary outcome variable. To determine the sensitivity, the application diagnosis will be compared against the clinical diagnosis of the physician.
The primary objective of the study is to assess the specificity of vocal biomarkers in patients with MCI and AD diagnosis
时间窗: Upon enrollment
The CANARY application will use clinically validated survey instruments and voice recordings to analyze the data and determine the patient's MCI/ Alzheimer's disease diagnosis. The diagnosis developed by the application is the primary outcome variable. To determine the specificity, the application diagnosis will be compared against the clinical diagnosis of the physician.
次要结局
未报告次要终点