UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058572
Receipt number R000066974
Scientific Title Joint research on the relationship between brain microstructure, brain deposits, and brain function using MRI in neurodegenerative diseases and neuropsychiatric disorders
Date of disclosure of the study information 2025/07/23
Last modified on 2025/07/23 20:34:31

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Basic information

Public title

Joint research on the relationship between brain microstructure, brain deposits, and brain function using MRI in neurodegenerative diseases and neuropsychiatric disorders

Acronym

Joint research using MRI in neurodegenerative diseases and neuropsychiatric disorders

Scientific Title

Joint research on the relationship between brain microstructure, brain deposits, and brain function using MRI in neurodegenerative diseases and neuropsychiatric disorders

Scientific Title:Acronym

Joint research using MRI in neurodegenerative diseases and neuropsychiatric disorders

Region

Japan


Condition

Condition

Neurodegenerative diseases and neuropsychiatric disorders

Classification by specialty

Neurology Psychiatry Radiology
Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to identify MRI markers related to brain microstructure, brain deposits, and brain function in neurodegenerative and psychiatric disorders, and to compare them with those of healthy individuals.

Basic objectives2

Others

Basic objectives -Others

By evaluating the relationship between the MRI markers, PET accumulation and other clinical biomarkers, we will identify the lesions associated with each disease and assess whether each MRI marker can be used for disease evaluation.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Significant differences in MRI markers (quantitative values) related to brain microstructure, brain deposits, and brain function between patients with each disease and healthy controls

Key secondary outcomes

Correlation between each MRI marker and PET accumulation, blood biomarkers, neuropsychological tests, and clinical symptoms


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects who underwent MRI or MRI and PET scans in existing studies conducted by QST targeting healthy individuals and those with neurodegenerative and psychiatric disorders.

Key exclusion criteria

1)Cases where the research subject or their representative refused to allow their data to be used for secondary research when the existing research was explained.
2)Cases where the research subject or their representative refused to allow their data to be used for this research when information about this research was disclosed.
3)Cases where there was missing data that affected data analysis.

Target sample size

2370


Research contact person

Name of lead principal investigator

1st name MARI
Middle name
Last name MIYATA

Organization

National Institutes for Quantum Science and Technology

Division name

Advanced Neuroimaging Center

Zip code

263-8555

Address

4-9-1 Anagawa, Inage-ku, Chiba

TEL

0432063251

Email

miyata.mari@qst.go.jp


Public contact

Name of contact person

1st name MARI
Middle name
Last name MIYATA

Organization

National Institutes for Quantum Science and Technology

Division name

Advanced Neuroimaging Center

Zip code

263-8555

Address

4-9-1 Anagawa, Inage-ku, Chiba

TEL

0432063251

Homepage URL


Email

miyata.mari@qst.go.jp


Sponsor or person

Institute

National Institutes for Quantum Science and Technology

Institute

Department

Personal name



Funding Source

Organization

NoneNational Institutes for Quantum Science and Technology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Natioanal institute of

Address

4-9-1 Anagawa, Inage-ku, Chiba

Tel

0432064713

Email

miyata.mari@qst.go.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

2025 Year 07 Month 23 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

Enrolling by invitation

Date of protocol fixation

2024 Year 07 Month 01 Day

Date of IRB

2025 Year 07 Month 15 Day

Anticipated trial start date

2025 Year 07 Month 15 Day

Last follow-up date

2030 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

MRI markers related to brain microstructure, brain deposits and brain function will be obtained at QST and joint research institutions, and disease groups will be compared with healthy groups. The correlation between these MRI markers and PET accumulation , blood biomarkers, neuropsychological tests, and clinical findings will then be evaluated.


Management information

Registered date

2025 Year 07 Month 23 Day

Last modified on

2025 Year 07 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066974