UMIN-CTR Clinical Trial

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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