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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2032210052
Enrollment
400
Registered
2021-04-26
Start date
2021-04-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Interventions

10 min free conversation between patient and medical practitioner based on questionaire will be recorded by the device.

Sponsors

Mimura Masaru
Lead Sponsor
Kyowa Pharmaceutical Industry .co, ltd
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: *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)

Design outcomes

Primary

MeasureTime frame
Sensitivity, specificity and accuracy of the AI system

Contacts

Public ContactRuiko Yamashita

FRONTEO Inc.

ruiko_yamashita@fronteo.com+81-3-5463-6330

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026