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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018496
Receipt No. R000021184
Scientific Title Evaluation and analysis of patients presenting neurodegenerative dementia or parkinsonism with [18F]THK-5351 positron emission tomography
Date of disclosure of the study information 2015/08/01
Last modified on 2018/10/21

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Basic information
Public title Evaluation and analysis of patients presenting neurodegenerative dementia or parkinsonism with [18F]THK-5351 positron emission tomography
Acronym Evaluation and analysis of patients presenting neurodegenerative disease with [18F]THK-5351 PET
Scientific Title Evaluation and analysis of patients presenting neurodegenerative dementia or parkinsonism with [18F]THK-5351 positron emission tomography
Scientific Title:Acronym Evaluation and analysis of patients presenting neurodegenerative disease with [18F]THK-5351 PET
Region
Japan

Condition
Condition mild cognitive impairment(MCI),Alzheimer-type dementia(AD), frontotemporal dementia(FTD), corticobasal degeneration(CBD),progressive supranuclear palsy(PSP),Parkinson's disease with dementia(PDD),dementia with Lewy bodies(DLB),Parkinson's disease(PD),multiple system atrophy(MSA),healthy control(HC)
Classification by specialty
Neurology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of [18F]THK-5351 PET when evaluating neurodegenerative diseases which tau proteins are thought to influence.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes About each neurodegenerative disease,We compare [18F]THK-5351 PET imaging with MRI and clnical syndrome.
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 We use [18F]THK-5351 as tau radiotracer by administration intravenously.
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 each disease;20
healthy control;40
Key exclusion criteria Persons who several doctors think it is difficult participate the trial.
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohisa Watanabe
Organization Nagoya University
Division name Brain and mind research center
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya-shi
TEL 052-744-1975
Email bmrc@adm.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamasa Yokoi
Organization Nagoya University
Division name Department of Neurology
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya-shi
TEL 052-744-1975
Homepage URL
Email tayokoi@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Department of Neurology
Institute
Department

Funding Source
Organization 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
2015 Year 08 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 Enrolling by invitation
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 11 Day
Last follow-up date
2020 Year 11 Month 10 Day
Date of closure to data entry
2020 Year 11 Month 10 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 30 Day
Last modified on
2018 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021184

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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