UMIN-CTR Clinical Trial

Basic information
Public title	Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3
Acronym	Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3
Scientific Title	Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3
Scientific Title:Acronym	Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3
Region	Japan

Condition
Condition	Alzheimer's disease (AD), mid cognitive impairment (MCI), progressive supranuclear pusy (PSP) and corticobasal syndrome (CBS).
Classification by specialty	Neurology Psychiatry Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to elucidate the efficacy and safety for [18F]PM-PBB3 among neurodegeneration (AD, MCI, PSP and CBS) sucjects and healthy controls.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacokinetic and quantitative analysis of [18F]PM-PBB3 Effective dose of [18F]PM-PBB3
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	1) PET ligand: [18F]PM-PBB3 administration dose: 5mCi number of dose: single dose 2) PET ligand: [11C]PBB3 administration dose: (body weight(kg)/5)mCi number of dose: single dose 3) PET ligand: [11C]BTA administration dose: 15mCi number of dose: single dose
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	(efficacy assessment) Healthy subjects: 1. Healthy subjects who have the ability to consent to participate in this study 2. 20 years of age or older at the time of obtaining consent Dementia subjects: 1. 20 years of age or older at the time of obtaining consent. 2. Subjects who can be accompanied by a legal guardian on the day of study participation at the NIRS. 3. AD, MCI: Subjects 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 PSP:Subjects meeting the criteria of NINDS-SPSP CBS: Subjects meeting the criteria of Mayo clinic and/or Cambridge (exposure dose assessment) 1. Healthy subjects who have the ability to consent to participate in this study 2. 50 years of age or older at the time of obtaining consent
Key exclusion criteria	1. Subjects who show obviously abnormal blood data at 1st day of the study 2. Subjects with organic brain complications/disorders (including a history of traumatic brain injury with loss of consciousness and/or hospital treatment, symptomatic cerebral infarction or hemorrhage) 3. Patients with substance-related disorders (including drug abuse) 4. 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 5. Subjects with a pacemaker or other metallic medical device in the body (brain clip, bolts, etc.) 6. Subjects with tattoos 7. Subjects with claustrophobia 8. Pregnant, possibly pregnant or lactating women 9. 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 12 months prior to the start of this study 10. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hitoshi Shimada
Organization	National Institute of Radiological Sciences
Division name	Department of Functional Brain Imaging Research
Zip code
Address	4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL	81432063025
Email	shimada.hitoshi@qst.go.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuko Suzuki
Organization	National Institute of Radiological Sciences
Division name	Clinical Research Support Section
Zip code
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	National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 03 Month 13 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	Completed
Date of protocol fixation	2017 Year 02 Month 24 Day
Date of IRB	2017 Year 02 Month 28 Day
Anticipated trial start date	2017 Year 03 Month 20 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	2017 Year 03 Month 10 Day
Last modified on	2020 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030428