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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014087
Receipt No. R000016401
Scientific Title Detection of tau deposition in normal brain aging and neurodegenerative disorders using tau imaging with [C-11]PBB3 and PET
Date of disclosure of the study information 2014/06/01
Last modified on 2020/06/03

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Basic information
Public title Detection of tau deposition in normal brain aging and neurodegenerative disorders using tau imaging with [C-11]PBB3 and PET
Acronym Tau imaging of normal aging and nenrodegeneration with [C-11]PBB3
Scientific Title Detection of tau deposition in normal brain aging and neurodegenerative disorders using tau imaging with [C-11]PBB3 and PET
Scientific Title:Acronym Tau imaging of normal aging and nenrodegeneration with [C-11]PBB3
Region
Japan

Condition
Condition Healthy volunteers and patients with neurodegenerative disorders
Classification by specialty
Neurology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Detection of tau deposition of the brain using tau PET with [C-11]PBB3
Basic objectives2 Others
Basic objectives -Others Investigation
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Standardized uptake value ratio (SUVR)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 The dosage in the vein of , [C-11]PiB, [F-18]FDG for PET/CT imaging.
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 1. Cognitively normal subjects or subjects who have neurodenegerative disorders. The subjects who has intention to participate in this study, and signed informed consent.
2. Male and female subjects of >= 20 years, old.
3. The subject who was judged by clinical investigator by means of physical examination and laboratory tests to be eligible as a participant in this study.
Key exclusion criteria 1.The subject who has dysfunction in the liver / kidney.
2.The subjects having cardiac failure.
3.The subject with a history of a drug or food allergy.
4. Pregnant or woman who has a chance of pregnant.
5.The subject who was judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Ishii
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Neuroimaging
Zip code 1730015
Address 35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL +81-3-3964-3241
Email ishii@pet.tmig.or.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Ishii
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Neuroimaging
Zip code 1730015
Address 35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL +81-3-3964-3241
Homepage URL
Email ishii@pet.tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee, Tokyo Metropolitan Institute of Gerontology
Address 35-2 Sakaecho, Itabashiku, Tokyo 1730015, Japan
Tel 0339643241
Email naomi_hasegawa@tmghig.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 地方独立行政法人東京都健康長寿医療センター研究所(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 06 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 Enrolling by invitation
Date of protocol fixation
2014 Year 02 Month 24 Day
Date of IRB
2014 Year 02 Month 03 Day
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 27 Day
Last modified on
2020 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016401

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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