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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039740
Receipt No. R000045324
Scientific Title Characterization of tau neuropathology of late-life psychiatric disorders: A PET study with 18F-PM-PBB3
Date of disclosure of the study information 2020/03/10
Last modified on 2020/03/09

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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

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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