UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050731 |
|---|---|
| Receipt number | R000057805 |
| Scientific Title | Research on the development of methods for stratification of neurodegenerative diseases using imaging and fluid biomarkers |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/03/31 01:38:46 |
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Basic information
Public title
Research on the development of methods for stratification of neurodegenerative diseases using imaging and fluid biomarkers
Acronym
Biomarker-Based Neurodegenerative Disease Stratification study
Scientific Title
Research on the development of methods for stratification of neurodegenerative diseases using imaging and fluid biomarkers
Scientific Title:Acronym
Biomarker-Based Neurodegenerative Disease Stratification study
Region
| Japan |
Condition
Condition
MCI, AD an CAA, CBS, PSP, iPD and DLB, ALS, NPH, and HC
Classification by specialty
| Neurology | Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate the relationship between clinical features of various neurodegenerative disorders and abnormalities in the brain environment, such as altered synaptic density, tau and amyloid pathologies, assessed by PET, MRI (7T and 3T), and fluid biomarkers.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to investigate the relationship between clinical features of various neurodegenerative disorders and abnormalities in the brain environment, such as altered synaptic density, tau and amyloid pathologies, assessed by PET, MRI (7T and 3T), and fluid biomarkers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain reginal distribution volume and binding capacity of 18F-PM-PBB3
Key secondary outcomes
Association between neurological symptoms and neurological pathologies/damage assessed by 18F-PM-PBB3 and
18F-flutemetamol or 11C-PiB PET, MRI and fluid biomarkers
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
| Medicine |
Interventions/Control_1
Venipuncture and radiopharmaceutical administration in PET studies in healthy volunteers
Interventions/Control_2
Venipuncture and radiopharmaceutical administration in PET studies in patients volunteers
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
[Cognitively healthy volunteers]
1. 20 years of age or older at the time of obtaining consent.
2. Healthy adults who are determined to be eligible for the study by the investigator or sub-investigator's examination.
[Patient volunteers]
1. 20 years of age or older at the time of obtaining consent.
2. The diagnostic criteria for each disease are as follows.
1) MCI: Those who meet the diagnostic criteria by Petersen
2) AD: Those who meet the 2011 NIA-AA criteria
3) CBS: Those who meet the diagnostic criteria of Mayo clinic and/or modified Cambridge diagnostic criteria
4) PSP: Those who meet the MDS PSP diagnostic criteria and/or the diagnostic criteria by Kanazawa
5) FTLD: Those who meet the diagnostic criteria by Neary and/or are diagnosed as frontotemporal dementia and
parkinsonism linked to chromosome 17 (FTDP-17) with microtubule-associated protein tau (MAPT) mutation by
genetic testing (including unaffected carriers)
6) PD and DLB: Those who meet the MDS diagnostic criteria or the diagnostic criteria by McKeith. However, in
order to evaluate brain pathology including atypical cases, relative exclusion criteria ("red flags") should be allowed
in the diagnosis of PD, and items related to relative exclusion criteria should be omitted in the diagnosis.
7) ALS: Those who meet the revised El Esocrial criteria
8) iNPH: Those who meet the diagnostic criteria of guidelines for management of idiopathic normal pressure
hydrocephalus (second edition)
Key exclusion criteria
[Cognitively healthy volunteers]
1. Subjects with a history of or complications from organic brain diseases (consciousness disturbance, head trauma
requiring hospitalization, obvious cerebral infarction or intracranial hemorrhage, etc.)
2. Subjects with substance-related disorders
3. Subjects with severe physical complications/disorders or a history of such conditions
4. Subjects with pacemakers or internal metal (brain clips, bolts, etc.)
5. Subjects with tattoos (including tattoos and art makeup)
6. Subjects with claustrophobia
7. Pregnant, possibly pregnant or lactating women
8. Subjects who are deemed inappropriate to participate in the study by the principal investigator or subcontractor
[Patient volunteers]
1. Subjects with severe physical complications/disorders or a history of such conditions
2. Subjects with substance-related disorders
3. Subjects with claustrophobia
4. Pregnant, possibly pregnant or lactating women
5. Subjects who are deemed inappropriate to participate in the study by the principal investigator or subcontractor
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Shimada |
Organization
Brain Research Institute, Niigata University
Division name
Department of Functional Neurology & Neurosurgery, Center for Integrated Human Brain Science
Zip code
951-8585
Address
1-757 Asahimachi-dohri, Niigata, Niigata, Japan
TEL
+81-25-227-0683
shimada.hitoshi@bri.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Shimada |
Organization
Brain Research Institute, Niigata University
Division name
Department of Functional Neurology & Neurosurgery, Center for Integrated Human Brain Science
Zip code
951-8585
Address
1-757 Asahimachi-dohri, Niigata, Niigata, Japan
TEL
+81-25-227-0683
Homepage URL
shimada.hitoshi@bri.niigata-u.c.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-754 Asahimachi-dohri, Niigata, Niigata, Japan
Tel
+25-227-2625
ethics@adm.niigata-u.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
| 2023 | Year | 03 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057805
