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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038507
Receipt No. R000043879
Scientific Title 11C-preladenant imaging in Parkinson's disease
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/06

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Basic information
Public title 11C-preladenant imaging in Parkinson's disease
Acronym 11C-preladenant imaging in Parkinson's disease
Scientific Title 11C-preladenant imaging in Parkinson's disease
Scientific Title:Acronym 11C-preladenant imaging in Parkinson's disease
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the adenosine A2A receptors in Parkinson's disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To estimate 11C-preladenant 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 The subjects who were diagnosed with Parkinson's disease.
The subjects who can sign the informed consent.
Key exclusion criteria The subjects who cannot undergo MRI.
The subject who have chronic dysfunction in the organs.
Pregnant or woman who has a chance of pregnant.
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 Kenji
Middle name
Last name Ishibashi
Organization Tokyo Metropolitan Institute of Gerontology
Division name Neuroimaging
Zip code 173-001
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL 0339643241
Email ishibashi@pet.tmig.or.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Ishibashi
Organization Tokyo Metropolitan Institute of Gerontology
Division name Neuroimaging
Zip code 173-0015
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL 0339643241
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 Tokyo

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

IRB Contact (For public release)
Organization IRB at Tokyo Metropolitan Institute of Gerontology
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel 0339643241
Email sato@pet.tmig.or.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
2019 Year 12 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
2019 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No

Management information
Registered date
2019 Year 11 Month 06 Day
Last modified on
2019 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043879

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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