UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018774 |
|---|---|
| Receipt number | R000021697 |
| Scientific Title | Comparison of clinical and neuroimaging features of neurodegenerative disease using [11C]PBB3 PET |
| Date of disclosure of the study information | 2015/09/15 |
| Last modified on | 2015/09/23 17:51:21 |
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Basic information
Public title
Comparison of clinical and neuroimaging features of neurodegenerative disease using [11C]PBB3 PET
Acronym
Comparison of clinical and neuroimaging features of neurodegenerative disease using [11C]PBB3 PET
Scientific Title
Comparison of clinical and neuroimaging features of neurodegenerative disease using [11C]PBB3 PET
Scientific Title:Acronym
Comparison of clinical and neuroimaging features of neurodegenerative disease using [11C]PBB3 PET
Region
| Japan |
Condition
Condition
neurodegenerative disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of [11C]PBB3 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
Assessment
Primary outcomes
About each neurodegenerative disease,We compare [11C]PBB3 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
Self control
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 [11C]PBB3 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 | Kazunori Imai |
Organization
Nagoya University
Division name
Department of Neurology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya-shi
TEL
052-744-1975
Homepage URL
imai.kazunori@b.mbox.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
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 | 09 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | 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
| 2015 | Year | 08 | Month | 23 | Day |
Last modified on
| 2015 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021697
