UMIN-CTR Clinical Trial

Basic information
Public title	Characterization of tau neuropathology of late-life psychiatric disorders: A PET study with 18F-PM-PBB3
Acronym	Characterization of tau neuropathology of late-life psychiatric disorders: A PET study with 18F-PM-PBB3
Scientific Title	Characterization of tau neuropathology of late-life psychiatric disorders: A PET study with 18F-PM-PBB3
Scientific Title:Acronym	Characterization of tau neuropathology of late-life psychiatric disorders: A PET study with 18F-PM-PBB3
Region	Japan

Condition
Condition	Late-life psychiatric disorders
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to elucidate underlying neuropathology of late-life psychiatric disorders using tau imaing PET with 18F-PMPBB3.
Basic objectives2	Others
Basic objectives -Others	To elucidate the association between late-life psychiatric disorders and neurodegenerative diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Topology and quantification of 18F-PMPBB3 accumulation in the brain of patients with late-life psychiatric disorders and healthy subjects.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	PET with 18F-PMPBB3 / Neuropsychological tests
Interventions/Control_2	PET with 18F-PMPBB3 / Neuropsychological tests
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	Not applicable
Gender	Male and Female
Key inclusion criteria	I. Patients 40 y.o.<=Age patients with late-life psychiatric disorders II. Healthy volunteers 20 y.o.<=Age normal subjects
Key exclusion criteria	I. Patients 1. Subjects with a severe physical complication 2. Subjects with metallic medical device in the body 3. Subjects with severe claustrophobia 4. Subjects who tends to suicide 5. Pregnant women 6. Subjects who is considered to be inappropriate to participate in the study II. Healthy volunteers 1. Subjects with any psychiatric disorder 2. Subjects with any organic brain disorder 3. Subjects with severe physical complication 4. Subjects with metallic medical device in the body 5. Subjects with tattoo 6. Subjects with severe claustrophobia 7. Pregnant women 8. Subjects who has participated in other study in recent 6 months. 9. Subjects who is considered to be inappropriate to participate in the study
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Keisuke Middle name Last name Takahata
Organization	National Institute of Radiological Sciences (NIRS) National Institutes for Quantum and Radiological Science and Technology (QST)
Division name	Department of Functional Brain Imaging Research
Zip code	2638555
Address	4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
TEL	0432063251
Email	takahata.keisuke@qst.go.jp

Public contact
Name of contact person	1st name Keisuke Middle name Last name Takahata
Organization	National Institute of Radiological Sciences (NIRS) National Institutes for Quantum and Radiological
Division name	Department of Functional Brain Imaging Research
Zip code	2638555
Address	4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
TEL	0432063251
Homepage URL
Email	takahata.keisuke@qst.go.jp

Sponsor
Institute	National Institute of Radiological Sciences (NIRS) National Institutes for Quantum and Radiological
Institute
Department

Funding Source
Organization	National Institute of Radiological Sciences (NIRS) National Institutes for Quantum and Radiological
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	National Institute of Radiological Sciences (NIRS) National Institutes for Quantum and Radiological
Address	4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
Tel	81432063025
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	2020 Year 03 Month 10 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	2020 Year 02 Month 13 Day
Date of IRB	2020 Year 03 Month 02 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2025 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	2020 Year 03 Month 09 Day
Last modified on	2020 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045324