UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quantification of tau deposition using positron emission tomography with [11C]PBB3
Title of the study (Brief title)	PBB3 2nd protocol
Region	Japan

Condition
Condition	Healthy volunteer and Alzheimer's disease
Classification by specialty	Neurology Psychiatry Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of quantification method for amyloid deposition using positron emission tomography with [11C]PBB3
Basic objectives2	Others
Basic objectives -Others	Development of quantification method for amyloid deposition using positron emission tomography with [11C]PBB3
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Distribution volume and binding potential measured by positron emission tomography with [11C]PBB3 - Comparison between quantification methods - Comparison between patients and age- and gender-matched healthy controls
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	Diagnosis
Type of intervention	Other
Interventions/Control_1	PET/MRI/psychological batteries/neurological examinations
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	40 years-old <=
Age-upper limit	88 years-old >=
Gender	Male and Female
Key inclusion criteria	[healthy volunteer] 40y.o.<=Age<=88y.o., cognitive normal subjects without severe physical complication [Alzheimer's disease (AD)] 40y.o.<=Age<=88y.o., based on J-ADNI core study [Comprehensive Research on Aging and Health, The Ministry of Health Labour and Welfare, (19122701)] except CDR and MMSE, 0.5<=CDR<=2, 12<=MMSE<=26
Key exclusion criteria	1.psychiatric complications such as drug abuse, other organic brain complications such as symptomatic stroke, PD-related disorders and other neurodegenrative diseases 2.severe physical complications 3.allergy to lidocain or similar anethesia 4.subject who has metal such as pacemaker in the body, and cannot perform MRI examination 5.subjects with tattoo 6.subject with claustrophobia who cannot perform MRI examination 7.pregnant or lactating women 8.exclude the patients who are recognized as inadequate patients by doctors with resposibility in this study
Target sample size	20

Research contact person
Name of lead principal investigator	hitoshi Shimada
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Address	4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL	81432063025
Email	shimada@nirs.go.jp

Public contact
Name of contact person	hitoshi Shimada
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Address	4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL	+81-(0)43-206-3025
Homepage URL
Email	shimada@nirs.go.jp

Sponsor
Institute	National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization	a consignment expense for Molecular Imaging Program on "Research Base for PET diagnosis" from the Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japanese Government
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

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	2012 Year 10 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 05 Day
Anticipated trial start date	2012 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 10 Month 05 Day
Last modified on	2017 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010623