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临床试验/NCT07553117
NCT07553117已完成不适用

Assessment of Sensitivity and Specificity of a Machine Learning System for Detection and Monitoring of Mild Cognitive Impairment (Accexible) Through Speech Analysis in a Colombian Population

Accexible1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2022年5月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
1

研究概览

简要总结

Mild Cognitive Impairment (MCI) is frequently underdiagnosed due to its subtle clinical presentation. This study evaluates the diagnostic performance of AcceXible, a speech analysis-based machine learning platform, compared to the Montreal Cognitive Assessment (MoCA) for MCI detection and monitoring in Colombian patients.

A diagnostic test accuracy study will be conducted within a primary care setting (EPS Sanitas), including prior validation of the AcceXible protocol in the Colombian healthcare context.

The study pursues two primary aims: (1) to validate the AcceXible tool in a Colombian population, and (2) to demonstrate that AcceXible achieves high diagnostic accuracy for early MCI detection and longitudinal monitoring relative to the MoCA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to independently operate a mobile or portable device with internet connectivity and integrated microphone
  • Provision of voluntary written informed consent prior to study participation

排除标准

  • Diagnosed psychiatric disorder or cognitive impairment not attributable to neurodegenerative etiology
  • Visual impairment sufficient to preclude reading on-screen text or perceiving visual stimuli
  • Illiteracy
  • Hearing impairment sufficient to preclude comprehension of verbal instructions or detection of auditory test-onset cues

研究者

发起方
Accexible
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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