Dementia Diagnosis Support System (FRO-J001: AI Investigational Medical Device) Efficacy and Safety Evaluation Clinical Trial

FRONTEO Inc.0 个研究点目标入组 400 人开始时间: 2021年4月26日最近更新: 2022年4月14日

适应症

试验速览

暂无简介。

•Suspected Dementia (Undiagnosed)
•Age 45 and older, dementia is supected but undiagnosed
•Who has not undergone neuropsychological examination within last 6 months
•Dementia (Diagnosed)
•Age 45 and older, diagnosed as mild or moderate dementia
•Who has not undergone neuropsychological examination within last 3 months
•Healthy Subject
•Age 45 and older
•, 2), 3) in Common
•Who speak Japanese as his/her mother tongue and able to have an interview (conversation with doctors and medical staff)
•Who can obtain written consent from the person or his / her substitute
•Who has a study partner to anser CDR

•Who has been judged by a doctor to have difficulty in having conversation due to deafness, dysarthria, aphasia, etc.
•Who has been diagnosed or suspected of having a pyschiatric disorder such as depression
•Who has been judged by a doctor not to be suitable for this trial by any reasons
•Who has participated in AMED Study (data has been used for the development of this AI system)

Sensitivity, specificity and accuracy of the AI system

未报告次要终点

发起方