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

Mimura Masaru0 个研究点目标入组 400 人开始时间: 2021年4月26日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Suspected Dementia (Undiagnosed)
•*Age 45 and older, dementia is supected but undiagnosed
•*Who has not undergone neuropsychological examination within last 6 months
•2) Dementia (Diagnosed)
•*Age 45 and older, diagnosed as mild or moderate dementia
•*Who has not undergone neuropsychological examination within last 3 months
•3) Healthy Subject
•*Age 45 and older
•1), 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)

发起方

Mimura Masaru