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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032945
Receipt No. R000033184
Official scientific title of the study Evaluation of the magnetic susceptibility in the brain in patients with dementia
Date of disclosure of the study information 2018/06/11
Last modified on 2018/12/10

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Basic information
Official scientific title of the study Evaluation of the magnetic susceptibility in the brain in patients with dementia
Title of the study (Brief title) 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 Kohsuke Kudo
Organization Hokkaido University Hospital
Division name department of diagnostic and interventional radiology
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 Kohsuke Kudo
Organization Hokkaido University Hospital
Division name department of diagnostic and interventional radiology
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
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
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 12 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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