臨床研究等提出・公開システム

Scientific Title	Validation of a Cognitive Function Assessment Application
Public Title	Examination of Validity for a Dementia Assessment App

Contact for Scientific Queries	Name	Morigaki Ryoma
	Affiliation	Tokushima University
	Address	3-18-15 Kuramoto-cho, Tokushima city
	Telephone	+81-886337149
	E-mail	morigaki.riyoma.1@tokushima-u.ac.jp
Contact for Public Queries	Name	Fujikawa Joji
	Affiliation	Tokushima University
	Address	3-18-15 Kuramoto-cho, Tokushima city
	Telephone	+81-886337149
	E-mail	joji@tokushima-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		May. 28, 2024
Target sample size		51
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy, MCI, and Cognitive Impairment Patients Aged 60 and Above
	Exclusion Criteria	If Difficulty in Operating the Electronic Tablet.
	Age Minimum	60age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cognitive dysfunction
Intervention(s)		Dementia Tests
Health Condition(s) Keyword		Cognitive dysfunction
Intervention(s) Keyword		Dementia Tests
Health Condition(s) Code		D060825
Intervention(s) Code		D000073216
Primary Outcome(s)		Comparison of Performance with MMSE
Secondary Outcome(s)		Calculation of Cut-off Values for Classifying into Three Categories: Normal, MCI, and Cognitive Impairment

Primary Sponsor	none

Secondary Sponsor

Name of Certified Review Board	The ethical committee of Tokushima University Hospital
Address	2-50-1 Kuramoto-cho, Tokushima
Telephone	+81-88-633-7958
E-Mail	brinshoshienk@tokushima-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 25, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none