跳至主要内容
临床试验/NCT05534958
NCT05534958已完成不适用

Assessing the Diagnostic Accuracy of a Three One-minute Tests of Verbal Fluency, Using Artificial Intelligence, in Detecting Mild Cognitive Impairment and Early Dementia.

Accexible2 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2022年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
221
试验地点
2
主要终点
Diagnostic performance of Accexible's digital screening battery

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.

The present study has the objective of validating a digital method for detection and follow-up of patients with mild cognitive impairment (MCI) or dementia in a memory clinic setting.

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

入选标准

  • for patients:
  • Adult patients 55+ years of age with suspected MCI or diagnosis of dementia referred into secondary care memory clinic by their General Practitioner.
  • Have English as first language (able to speak and understand verbal messages).
  • Patients must have agreed to participate in the study and have voluntarily signed the informed consent.
  • Inclusion Criteria for healthy volunteers:
  • Healthy older adults (55+ years of age), without a diagnosis neurological, or psychiatric disorders or any clinical evidence of cognitive decline.
  • Have English as first language (able to speak and understand verbal messages).
  • Controls must have agreed to participate in the study and have voluntarily signed the informed consent.

排除标准

  • for patients:
  • 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.
  • To be unable to give informed consent to participate in the study.
  • Exclusion Criteria for healthy volunteers:
  • Objective evidence of significant cognitive decline in any one domain.
  • Score of <88 on ACE-III cognitive testing.

研究组 & 干预措施

Healthy

干预措施: Accexible (Device)

Mild Cognitive Impairment

干预措施: Accexible (Device)

Early Dementia

干预措施: Accexible (Device)

结局指标

主要结局

Diagnostic performance of Accexible's digital screening battery

时间窗: An average of 1 year

Measure the odds that a patient has MCI or dementia measured by vocal biomarkers

次要结局

  • Correlation of Accexible's test battery with the ACE III(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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