UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030248 |
|---|---|
| Receipt number | R000034546 |
| Scientific Title | Mapping of brain tau deposition in tauopathy by PET with [18F]PM-PBB3 |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2019/06/06 09:29:14 |
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Basic information
Public title
Mapping of brain tau deposition in tauopathy by PET with [18F]PM-PBB3
Acronym
Mapping of brain tau deposition in tauopathy by PET with [18F]PM-PBB3
Scientific Title
Mapping of brain tau deposition in tauopathy by PET with [18F]PM-PBB3
Scientific Title:Acronym
Mapping of brain tau deposition in tauopathy by PET with [18F]PM-PBB3
Region
| Japan |
Condition
Condition
mild cognitive impairment, Alzheimer's disease, corticobasal degeneration, progressive supranuclear palsy, frontotemporal degeneration, Parkinson's disease, Lewy body dementia,Amyotrophic Lateral Sclerosis/Parkinsonism-Dementia Complex Patients in Kii Peninsula, Diffuse neurofibrillary tangles with calcification, hereditary diffuse leukoencephalopathy with spheroid,Progressive Ataxia and Palatal Tremor, traumatic brain injury
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to define tau pathology in the brain of patients with neurodegenerative disease using [18F]PM-PBB3 PET
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
correlation between [18F]PM-PBB3-PET and clinical symptoms
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/MRI/psychological batteries/neurological examinations
Interventions/Control_2
PET/MRI/psychological batteries/neurological examinations
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
Subjects with neurodegenerative disease
1.20 years of age or older at the time of obtaining consent.
2.Subjects who can be accompanied by a legal guardian on the day of study participation at the NIRS.
3. Subjects meeting criterias of tauopathy
Subjects with traumatic brain injury
1.20 years of age or older at the time of obtaining consent.
2.Subjects who can be accompanied by a legal guardian on the day of study participation at the NIRS.
3.Subjects with ability to make informed consent
Healthy volunteers
1.20 years of age or older at the time of obtaining consent.
2.Subjects with ability to make informed consent
2.Subjects who can be accompanied by a legal guardian on the day of study participation at the NIRS.
3.Subjects with ability to make informed consent
Healthy volunteers
1.20 years of age or older at the time of obtaining consent.
2.Subjects with ability to make informed consent
Key exclusion criteria
1) Subjects with neurodegenerative disease
1. Subjects with organic brain complications/disorders
2.Subjects with substance-related disorders
3.Subjects with severe physical complications/disorders or a history of such conditions
4. Subjects with claustrophobia
5. Pregnant, possibly pregnant or lactating women
6. From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study
7. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
2) Subjects with traumatic brain injury
1. Subjects with any organic brain disorder not due to traumatic brain injury
2. Subjects with severe physical complications/disorders or a history of such conditions
3. Subjects with claustrophobia
4. Pregnant, possibly pregnant or lactating women
5. From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study
6. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
3) Healthy volunteers
1. Subjects with organic brain complications/disorders
2. Subjects with substance-related disorders
3.Subjects with severe physical complications/disorders or a history of such conditions
4. Subjects with claustrophobia
5. Pregnant, possibly pregnant or lactating women
6. From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study
7. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
8. Subjects with tattoo
9. Subjects with metallic medical device in the body
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Shimada |
Organization
National Institute of Radiological Sciences
Division name
Department of Functional Brain Imaging Research
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
shimada.hitoshi@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Suzuki |
Organization
National Institute of Radiological Sciences
Division name
Clinical Research Support Section
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
Homepage URL
suzuki.kazuko@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
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
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
| 2018 | Year | 01 | 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
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034546
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