UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032945
Receipt number R000033184
Scientific Title 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 2022/06/15 10:22:56

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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 or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



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

Value
https://center6.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