跳至主要内容
临床试验/NCT05380297
NCT05380297已完成不适用

Validación Del método de análisis Automatizado Del Habla "AcceXible" Para la detección Temprana y Seguimiento de Pacientes Con Deterioro Cognitivo Leve o Demencia en atención Primaria.

Accexible2 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2021年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
273
试验地点
2
主要终点
Vocal biomarkers to assess pre-post variability of normal, MCI and dementia at both point of the study.

研究概览

简要总结

Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. The sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration.

A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.

Thus, the purpose of this study is to validate speech analysis AI models.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
55 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients 55+ years of age with suspected MCI or diagnosis of dementia and obtains a score greater than 20 on the MMSE.
  • Patients must have agreed to participate in the study and have voluntarily signed the informed consent.
  • (Healthy) Participants without a diagnosis neurological, or psychiatric disorders. Or taking medication that can affect cognitive abilities.

排除标准

  • To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.
  • To have significant vision problems that would affect the ability to perceive visual stimuli.
  • To have significant hearing problems that would affect the ability to understand verbal cues.

结局指标

主要结局

Vocal biomarkers to assess pre-post variability of normal, MCI and dementia at both point of the study.

时间窗: Change from the baseline cognitive function at 9 months.

Standard deviation of normal subjects, MCI and dementia to measure variations in language by using vocal biomarkers.

次要结局

  • Correlation between standard cognitive test (MMSE) and linguistic variables obtained by vocal biomarkers.(Through study completion, an average of 1 year.)

研究者

发起方
Accexible
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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