UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014785 |
|---|---|
| Receipt number | R000017170 |
| Scientific Title | The study on the usefulness of positron emission tomography wtih [11C]PBB3 |
| Date of disclosure of the study information | 2014/08/18 |
| Last modified on | 2020/08/14 15:09:57 |
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Basic information
Public title
The study on the usefulness of positron emission tomography wtih [11C]PBB3
Acronym
The usefulness of tau imaging
Scientific Title
The study on the usefulness of positron emission tomography wtih [11C]PBB3
Scientific Title:Acronym
The usefulness of tau imaging
Region
| Japan |
Condition
Condition
Alzheimer's disease
Psychotic disorders
Mood disorders
Traumatic brain injury
Epilepsy
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the tau accumulation, progress of pathology, and types of the tau pathology among various disease which were affected by tau pathology. To clarify the relationship between clinical symptoms of the disease and tau protein.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of accumulation and distribution of tau protein in brain.
Key secondary outcomes
Degree of accumulation and distribution of beta-amyloid in brain
neuropsychiatrci examination
clinical symptoms
morphometric MRI
functional MRI
blood test
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
8
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_2
PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_3
PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_4
PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_5
PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_6
PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_7
PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_8
PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who have the ability to provide informed consent and adhere to the protocol.
Normal controls:
- Without past or current history of cognitive dysfunction
- Without past or current history of disease and injury that influences the central nervous system
- Mini-Mental State Exam score is 28 or more
Alzheimer's disease:
- Subject who meet the diagnostic criteria of Alzheimer's disease on International classification of Diseases 10th revision
- Informed consents are obtained from patients and one of their family members
Psychotic disroders:
- Subject who meet the diagnostic criteria of F2 on International classification of Diseases 10th revision
Mood disorders:
- Subject who meet the diagnostic criteria of F3 on International classification of Diseases 10th revision
Brain injury: Subjects with past history of traumatic brain injury
Epilepsy: Subjects with past history of seizure and with electroencephalogram abnormality
Key exclusion criteria
- With past or current history of serious medical illness
- With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- Subjects who has possibility of pregnancy or is breast-feeding
- Subjects who has been exposed to radiation by job-related exposure or therapy in one year exceeding 15mSv
- Subjects who received contrast or radioactive agent within two days of the examination.
- Subjects who scheduled receiving contrast or radioactive agent the day after the examination.
- Subjects who are judged as not suitable for participation in this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Okubo |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
okubo-y@nms.ac.jp
Public contact
Name of contact person
| 1st name | Amane |
| Middle name | |
| Last name | Tateno |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
amtateno@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital Institutional Review Board
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
03-3822-2131
clinicaltrial@nms.ac.jp
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
| 2014 | Year | 08 | Month | 18 | 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
| 2014 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 07 | Day |
Last modified on
| 2020 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017170
