UMIN-CTR Clinical Trial

Basic information
Public title	Mapping of brain tau deposition in tauopathy by PET with [11C]PBB3
Acronym	PBB3 3rd protocol
Scientific Title	Mapping of brain tau deposition in tauopathy by PET with [11C]PBB3
Scientific Title:Acronym	PBB3 3rd protocol
Region	Japan

Condition
Condition	Healthy volunteers 20 years of age or older at the time of obtaining consent Patients with mild cognitive impairment (MCI) 20 years of age or older at the time of obtaining consent Patients with Alzheimer's disease (AD) 20 years of age or older at the time of obtaining consent Patients with corticobasal degeneration (CBD) 20 years of age or older at the time of obtaining consent Patients with progressive supranuclear palsy (PSP) 20 years of age or older at the time of obtaining consent Patients with frontotemporal dementia (FTD) 20 years of age or older at the time of obtaining consent Patients with familial Parkinson's disease with the LRRK2 genetic mutation (PARK8)
Classification by specialty	Neurology Psychiatry Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To characterize brain tau deposition in tauopathy in vivo using PET.
Basic objectives2	Others
Basic objectives -Others	To characterize brain tau deposition in tauopathy in vivo using PET.
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 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy volunteer 1. 20 years of age or older at the time of obtaining consent. For the judgment of whether or not subject cognitive function can be deemed normal. 2. In order to reduce gender bias, subjects will be selected to match the male-to-female ratios of the patient groups to the maximum extent possible. 3. Healthy subjects who have the ability to consent to participate in this study, to read and understand the informed consent form. Patients with MCI, AD, CBD, PSP, FTD and PARK8 1. Patients 20 years of age or older at the time of obtaining consent. 2. Patients with MCI and patients with AD: Patients meeting the inclusion criteria in the J-ADNI core study except for age. However, the range of CDR (Clinical dementia rating) in patients with AD will be 0.5-2, and the range of MMSE (Mini Mental State Examination) will be 26 points or less, and the acceptable range of drugs that can be used will be partially changed. Patients with CBD: Patients meeting the diagnostic criteria of the Mayo Clinic (Boeve BF, 2003) and/or the modified version of the Cambridge diagnostic criteria (Mathew R, 2011). Patients with PSP: Patients meeting the NINDS-SPSP diagnostic criteria (Litvan I, 1996). Patients with FTD: Patients meeting the diagnostic criteria of Neary et al. (Neary D, 1998), and/or patients diagnosed with FTD and parkinsonism linked to chromosome 17; FTDP-17 (MAPT) based on genetic testing (including presymptomatic carriers). Patients with PARK8: Patients diagnosed as PARK8 based on genetic testing. 3. Patients who can be accompanied by a legal guardian on the day of study participation at the NIRS. 4. Patients who can understand the outline of this study at the time consent is obtained. Two or more doctors in the collaborating study institutions and the NIRS will judge whether or not the patient can understand the study outline.
Key exclusion criteria	healthy volunteer 1. Subjects with organic brain complications/disorders (including a history of symptomatic cerebral infarction, Parkinson's disease and similar conditions). 2. Patients with substance-related disorders (including drug abuse). For the acceptable range of allowable drugs. 3. Subjects with severe physical complications/disorders or a history of such conditions and who are considered to be inappropriate for participation by the aforementioned doctors with responsibilities in this study. 4. Subjects with a pacemaker or other metallic medical device in the body (brain clip, bolts, etc.). 5. Subjects with tattoos. Subjects with claustrophobia. 6. Pregnant, possibly pregnant or lactating women. 7. From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study. 8. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study. Patients with MCI, AD, CBD, PSP, FTD and PARK8 1. Patients with other organic brain complications/disorders (including a history of symptomatic cerebral infarction, Parkinson's disease and similar conditions). 2. Patients with substance-related disorders (including drug abuse). For the acceptable range of allowable drugs. 3. Patients with severe physical complications/disorders or a history of such conditions and who are considered to be inappropriate for participation by doctors with responsibilities in this study. 4. Patients with claustrophobia. 5. Pregnant, possibly pregnant or lactating women. 6. Patients who are considered to be inappropriate for participation by doctors with responsibilities in this study.
Target sample size	146

Research contact person
Name of lead principal investigator	1st name hitoshi Middle name Last name Shimada
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Zip code	2638555
Address	4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL	81432063025
Email	shim@alpha.ocn.ne.jp

Public contact
Name of contact person	1st name kazuko Middle name Last name Suzuki
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Zip code	2638555
Address	4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL	81432063025
Homepage URL
Email	suzuki.kazuko@qst.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	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	National Institute of Radiological Sciences
Address	4-9-1,Anagawa,Inage-ku, Chiba
Tel	+81-(0)43-206-3025
Email	helsinki@qst.go.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	2013 Year 02 Month 14 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	124
Results	The distribution of tau PET ([11C]PBB3-PET) were consistent with pathological findings. The increased accumulation was associated with the severity of dementia and brain atrophy.
Results date posted	2022 Year 08 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	NA
Participant flow	NA
Adverse events	none
Outcome measures	NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 21 Day
Date of IRB	2013 Year 01 Month 21 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 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	2013 Year 01 Month 24 Day
Last modified on	2022 Year 08 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011558