臨床研究等提出・公開システム

Date of registration	April. 26, 2021
Last modified on	April. 14, 2022
Trial ID	jRCT2032210052

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

Contact for Scientific Queries	Name	Mimura Masaru
	Affiliation	Keio University
	Address	35 Shinanomachi, Shinjuku-ku
	Telephone	+81-3-3353-1211
	E-mail	mimura@a7.keio.jp
Contact for Public Queries	Name	Yamashita Ruiko
	Affiliation	FRONTEO Inc.
	Address	2-12-23 Konan, Minato-ku, Tokyo Japan
	Telephone	+81-3-5463-6330
	E-mail	ruiko_yamashita@fronteo.com

Recruitment status	Complete

Anticipated date of first enrollment		April. 26, 2021
Actual date of first enrollment		April. 26, 2021
Target sample size		400
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	screening
Key inclusion & exclusion 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	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)
	Age Minimum	45age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Dementia
Intervention(s)		10 min free conversation between patient and medical practitioner based on questionaire will be recorded by the device.
Primary Outcome(s)		Sensitivity, specificity and accuracy of the AI system

Primary Sponsor	FRONTEO Inc.

Source of Monetary Support	Kyowa Pharmaceutical Industry .co, ltd
Secondary Sponsor	Applicable

Name of Certified Review Board	Jinbo Orthopedics IRB
Address	5-38-41, Koganei-City, Tokyo
Telephone	+81-42-304-1801
E-Mail	chi-pr-cirb-jinbo@cmicgroup.com
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Kobe University Hospital
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Kochi University Hospital
Address	185-1 Okocho Kohasu, Nankoku-city , Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Tohoku Clinical Research Review Organization
Address	1-1 Seiryo-mach, Aoba-ku, Sendai-city, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Tokyo Matsuzawa Hospital
Address	2-1-1 Kamikitazawa, Setagaya-ku, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	National Center for Geriatrics and Gerontology
Address	7-430 Morioka-cho, Obu-city, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Tokyo Metropolitan Geriatric Medical Center
Address	35-2 Sakae-cho, Itabashi-ku, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Teine Keijinka Hospital
Address	12-1-40, Maeda 1-jo, Teine-ku, Sapporo-city, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Hayshi Diabetes Clinic
Address	3-2 Shinei-cho, Chigasaki, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Shoda Hospital
Address	1-16-32 Annaka, Annaka-city, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Suda Clinic
Address	2-8-14 Takadanobaba, Shinjuku-ku, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Adachi Kyosai Hospital
Address	1-36-8 Yanagihara, Adachi-ku, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Kieo University Hospital
Address	35 Shinano-machi, Shinjuku-ku, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Tsukuba University Hospital
Address	2-1-1 Amakubo, Tsukuba-city, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Mizuo Clinic
Address	3-9-1 Nakata-minami, Izumi-ku, Yokohama-city, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Rakuwwa Otowa HOspital
Address	2 Otowa Chinji-cho, Yamashina-ku, Kyoto City, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Name of Certified Review Board	Fukuoka University Hospital
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Tokyo
Approval Status	Approval
Date of approval	April. 22, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	April. 14, 2022	(this page)	Changes
3	Feb. 10, 2022	Detail	Changes
2	May. 13, 2021	Detail	Changes
1	April. 26, 2021	Detail

List of change history