UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018496 |
|---|---|
| Receipt number | 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 | 2021/08/03 18:43:20 |
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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
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
tayokoi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Department of Neurology
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 01 | Day |
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
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021184
