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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032007
Receipt No. R000036528
Scientific Title Glial imaging in neuropsychiatric diseases using CB184 and THK 5351
Date of disclosure of the study information 2018/04/01
Last modified on 2018/03/30

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Basic information
Public title Glial imaging in neuropsychiatric diseases using CB184 and THK 5351
Acronym Glial imaging in neuropsychiatric diseases
Scientific Title Glial imaging in neuropsychiatric diseases using CB184 and THK 5351
Scientific Title:Acronym Glial imaging in neuropsychiatric diseases
Region
Japan

Condition
Condition neuropsychiatric diseases
Classification by specialty
Neurology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 investigate the quality of CB184 and THK5351 in neuropsychiatric diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes measurement of CB184 and THK5351 bindings
Key secondary outcomes

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 1. The subjects who have intention to participate in this study, and signed informed consent.
2. Male and female subjects of >=20 and <90 years, old.
3. The subjects who were diagnosed with a neuropsychiatric disease
Key exclusion criteria 1. The subjects who cannnot undergo MRI scan.
2. The subject who have chronic dysfunction in the organs.
3. Pregnant or woman who has a chance of pregnant.
4. The subjects who were judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kenji Ishibashi
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Neuroimaging
Zip code
Address 35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL 03-3964-3241
Email ishibashi@pet.tmig.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name kenji Ishibashi
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Neuroimaging
Zip code
Address 35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL 03-3964-3241
Homepage URL
Email ishibashi@pet.tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization Tokyo Metropolitan Institute of Gerontology
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
Address
Tel
Email

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 04 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
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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2018 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036528

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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