UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043140 |
|---|---|
| Receipt number | R000049242 |
| Scientific Title | Collaborative study on longitudinal tau accumulation of [18F]PM-PBB3 ([18F]APN-1607) in patients with Parkinson's disease-related disorders |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2023/07/31 18:19:41 |
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Basic information
Public title
Collaborative study on longitudinal tau accumulation of [18F]PM-PBB3 ([18F]APN-1607) in patients with Parkinson's disease-related disorders
Acronym
Longitudinal collaborative study with [18F]PM-PBB3 ([18F]APN-1607)
Scientific Title
Collaborative study on longitudinal tau accumulation of [18F]PM-PBB3 ([18F]APN-1607) in patients with Parkinson's disease-related disorders
Scientific Title:Acronym
Longitudinal collaborative study with [18F]PM-PBB3 ([18F]APN-1607)
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
Parkinson's disease-relatd disorders (progressive supranuclear palsy spectrum, parkinson's disease)
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to quantitatively evaluate the distribution of tau protein lesions in the brain and to understand their changes over time in order to explore the pathological basis of the disease and its clinical manifestations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between [18F]PM-PBB3([18F]APN-1607) PET changes over time and clinical symptoms
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
<Cross-sectional study>
Healthy volunteers who have participated in the following existing studies conducted by QST since February 2017, and who have undergone testing by December 31, 2019.
1) Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3 (Research Protocol No. 16-036)
2) Tau PET imaging in patients with schizophrenia and patients with frontotemporal dementia (No. 16-037)
3) PET study of central PDE10A density and tau deposition in bipolar disorder. (No. 17-027)
<Longitudinal study>
Healthy volunteers, patients with Parkinson's disease, and patients with progressive supranuclear palsy spectrum among the study subjects who participated in the following existing studies conducted at QST after November 2017.
Mapping of brain tau deposition in tauopathy by PET with [18F]PM-PBB3 (No. 17-034)
Key exclusion criteria
(1) Cases in which the research subject or his/her representative refuses the secondary use of data for other research when the existing research is explained.
(2) Cases in which the research subject or his/her representative refuses the use of the data for this research at the time the data is shared with the collaborating research organization.
(3) Cases in which there is missing data that may affect data analysis.
Target sample size
59
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Endo |
Organization
National Institutes for Quantum Science and Technology
Division name
Department of Functional Brain Imaging
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
0432063249
endo.hironobu@qst.go.jp
Public contact
Name of contact person
| 1st name | Shizuko |
| Middle name | |
| Last name | Kawakami |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Clinical Research Support Section
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432064713
Homepage URL
kawakami.shizuko@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Biogen MA Inc
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Biogen MA Inc
Name of secondary funder(s)
APRINOIA Therapeutics Inc
IRB Contact (For public release)
Organization
Certified Review Board
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
Tel
81432064706
helsinki@qst.go.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
| 2021 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
59
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
| 2020 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Cross-sectional study>
Healthy volunteers who have participated in the following existing studies conducted by QST since February 2017, and who have undergone testing by December 31, 2019.
1) Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3 (Research Protocol No. 16-036)
2) Tau PET imaging in patients with schizophrenia and patients with frontotemporal dementia (No. 16-037)
3) PET study of central PDE10A density and tau deposition in bipolar disorder. (No. 17-027)
<Longitudinal study>
Healthy volunteers, patients with Parkinson's disease, and patients with progressive supranuclear palsy spectrum among the study subjects who participated in the following existing studies conducted at QST after November 2017.
Mapping of brain tau deposition in tauopathy by PET with [18F]PM-PBB3 (No. 17-034)
Management information
Registered date
| 2021 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049242
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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