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Recruitment status
Unique ID issued by UMIN UMIN000022949
Receipt No. R000025337
Scientific Title Multicenter study of [18F]-THK-5351 PET in tauopathies
Date of disclosure of the study information 2016/07/01
Last modified on 2018/07/03

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Basic information
Public title Multicenter study of [18F]-THK-5351 PET in tauopathies
Acronym [18F]-THK-5351 PET in tauopathies
Scientific Title Multicenter study of [18F]-THK-5351 PET in tauopathies
Scientific Title:Acronym [18F]-THK-5351 PET in tauopathies
Region
Japan

Condition
Condition tauopathy
Classification by specialty
Neurology Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate usefulness of Tau PET imaging for diagnosing tauopathies and to differentiate aging and pathological tau accumulation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Distribution pattern of [18F]-THK-5351 in each tauopathy.
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
Medicine
Interventions/Control_1 PET examination
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
35 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Clinical suspicious of tauopathy
Key exclusion criteria #brain infarction, hydrocephalus, metabolic disorder, tumor, inflammation
#claustrophobia
#cardiac pacemaker insertion, metabolic insertion, tatoo
#attending other study including nuclear medicine examination
#decision made by attending physician
#denying to get the results of examinations
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HARUMASA TAKANO
Organization National Center of Neurology and Psychiatry
Division name Integrative Brain Imaging Center
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2711
Email hrtakano@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name HARUMASA TAKANO
Organization National Center of Neurology and Psychiatry
Division name Integrative Brain Imaging Center
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2711
Homepage URL
Email hrtakano@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 07 Month 01 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
Date of protocol fixation
2016 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 30 Day
Last modified on
2018 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025337

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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