UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the magnetic susceptibility in the brain in patients with dementia
Acronym	Evaluation of the magnetic susceptibility in dementia
Scientific Title	Evaluation of the magnetic susceptibility in the brain in patients with dementia
Scientific Title:Acronym	Evaluation of the magnetic susceptibility in dementia
Region	Japan

Condition
Condition	Dementia
Classification by specialty	Neurology Psychiatry Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the local magnetic susceptibility in quantitative susceptibility mapping (QSM) between Alzheimer's patients and cognitively normal control
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of the local magnetic susceptibility in quantitative susceptibility mapping (QSM) between Alzheimer's patients and cognitively normal control
Key secondary outcomes	1) Comparison of the local magnetic susceptibility in QSM among Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, vascular dementia, mild cognitive impairment, and others 2) Comparison of the local cerebral blood flow in arterial spin labelling (ASL) between Alzheimer's patients and control group. 3) Comparison of the local diffusion parameters in diffusion tensor image (DTI) between Alzheimer's patients and control group. 4) Comparison of the local T1 and T2* values in quantitative parametrical mapping between Alzheimer's patients and control group. 5) Correlation between the local magnetic susceptibility and other imaging parameters. 6) Correlation between local magnetic susceptibility, cognitive function test, and blood exams 7) Correlation between local magnetic susceptibility and amyloid deposition in amyloid PET

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	[Patients Group] 1) >20 and <90 years old 2) MRI examination within one month after obtaining informed consent, or susceptibility weighted images were scanned in past MRI exam. 3) informed consent is obtained after detailed explanation [Control Group] 1) sex and age matched subjects with patients group 2) informed consent is obtained
Key exclusion criteria	[Patients Group] (1)metallic implant and other MRI contraindicated objects (2)pregnant female (including possible case) (3)claustrophobia [Control Group] (1)the score of cognitive function test: MMSE<26, and MOCA-J<25 (2)abnormal MR findings or poor image quality due to motion artifact or other causes
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Kohsuke Middle name Last name Kudo
Organization	Hokkaido University Hospital
Division name	department of diagnostic and interventional radiology
Zip code	060-8648
Address	Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL	011-706-7779
Email	kkudo@huhp.hokudai.ac.jp

Public contact
Name of contact person	1st name Kohsuke Middle name Last name Kudo
Organization	Hokkaido University Hospital
Division name	department of diagnostic and interventional radiology
Zip code	060-8648
Address	Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL	011-706-7779
Homepage URL
Email	kkudo@huhp.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Hokkaido University Hospital
Address	N14W5 Kita-ku Sapporo
Tel	011-716-1161
Email	crjimu@huhp.hokudai.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	北海道大学病院（北海道）、岩手医科大学（岩手県）、徳島大学（徳島県）、名古屋市立大学（愛知県)

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 11 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
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	No longer recruiting
Date of protocol fixation	2017 Year 09 Month 01 Day
Date of IRB	2017 Year 09 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 06 Day
Last follow-up date	2019 Year 04 Month 01 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information	observation study. Performing tests of cognitive function and MRI exams for dementia patients and cognitive normal control group.

Management information
Registered date	2018 Year 06 Month 11 Day
Last modified on	2022 Year 06 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033184