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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030248
Receipt No. 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

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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
Email 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
Email suzuki.kazuko@qst.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034546

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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