UMIN-CTR Clinical Trial

Basic information
Public title	Examination of predicting factor of cognitive decline
Acronym	Study of predicting factor of cognitive decline
Scientific Title	Examination of predicting factor of cognitive decline
Scientific Title:Acronym	Study of predicting factor of cognitive decline
Region	Japan

Condition
Condition	Diabetes Mellitus, traumatic brain injury, depression, mild cognitive impairment
Classification by specialty	Endocrinology and Metabolism Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the predictive factor of the cognitive decline in each diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	examination at the initial evaluation: signal of [18F]flrobetapir
Key secondary outcomes	examination at the initial evaluation, 1 year evaluation, 2 year evaluation: cognitive function blood test urine test clinical symptoms diagnosis

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	Prevention
Type of intervention	Other
Interventions/Control_1	Initial evaluation: [18F]flrobetapir PET (370MBq), MRI, Neuropsychological examination, blood test, urine test 1st year evaluation: Neuropsychological examination, blood test, urine test 2nd year evaluation: Neuropsychological examination, blood test, urine test
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects (20 y.o. <= age <90 y.o.) who have the ability to provide informed consent and adhere to the protocol. Diabetes mellitus: - Subjects who meet the critera of diabetes mellitus on the Japan Diabetes Society without past history of traumatic brain injury and major depressive disorder Traumatic brain in jury: Subjects with past history of traumatic brain injury, without past history of diabetes mellitus and major depressive disorder Major depressive disorder: - Subject who meet the diagnostic criteria of depressive episode on International classification of Diseases 10th revision Mild cognitive impairment: - Subject who had subjective and objective cognitive impairment without past history of diabetes mellitus, traumatic brain injury
Key exclusion criteria	- With past or current history of serious medical illness - Subject who cannot undergo an MRI - With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy - Subjects who has possibility of pregnancy or is breast-feeding - Subjects who has been exposed to radiation by job-related exposure or therapy in one year exceeding 15mSv - Subjects who received contrast or radioactive agent within two days of the examination. - Subjects who scheduled receiving contrast or radioactive agent the day after the examination. - Subjects who are judged as not suitable for participation in this study
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Yoshiro Middle name Last name Okubo
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Zip code	113-8602
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL	03-3822-2131
Email	okubo-y@nms.ac.jp

Public contact
Name of contact person	1st name Amane Middle name Last name Tateno
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Zip code	113-8602
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL	03-3822-2131
Homepage URL
Email	amtateno@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nippon Medical School Hospital Institutional Review Board
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
Tel	+81-3-3822-2131
Email	clinicaltrial@nms.ac.jp

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	2018 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 12 Month 17 Day
Date of IRB	2017 Year 10 Month 06 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 09 Month 30 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 17 Day
Last modified on	2019 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034643