UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of cognitive decline and alterations in brain networks
Title of the study (Brief title)	The study of cognitive decline and alterations in brain networks
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship of cognitive decline and brain networks for healthy adults.
Basic objectives2	Others
Basic objectives -Others	To investigate the mechanisms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The data of cognitive abilities and MRI
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Cognitive and psychological test, MRI
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Aged 20- years-old, male and female 2) No serious psychiatric disorders or medical illness. 3) Capability of informed consent
Key exclusion criteria	1) Subjects who are contraindicated for the use of MRI (e.g., implanted cardiac pacemaker, surgical aneurysm clips) 2) Subjects with pregnancy 3) Metal fragments in body 4) Subjects who are judged as unsuitable for participation in this study
Target sample size	40

Research contact person
Name of lead principal investigator	Junya Fujino
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Address	6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan
TEL	03-5315-9357
Email	fujinoj@med.showa-u.ac.jp

Public contact
Name of contact person	Junya Fujino
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Address	6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan
TEL	03-5315-9357
Homepage URL
Email	fujinoj@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	National Institute of Information and Communications Technology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 10 Day
Last modified on	2017 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032757