UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054601 |
|---|---|
| Receipt number | R000062374 |
| Scientific Title | Evaluations of chronic neuroinflammation and tau accumulations secondary to various CNS diseases; A PET and postmortem study |
| Date of disclosure of the study information | 2024/06/12 |
| Last modified on | 2024/06/07 10:23:42 |
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Basic information
Public title
Evaluations of chronic neuroinflammation and tau accumulations secondary to various CNS diseases; A PET and postmortem study
Acronym
Evaluations of chronic neuroinflammation and tau accumulations secondary to various CNS diseases; A PET and postmortem study
Scientific Title
Evaluations of chronic neuroinflammation and tau accumulations secondary to various CNS diseases; A PET and postmortem study
Scientific Title:Acronym
Evaluations of chronic neuroinflammation and tau accumulations secondary to various CNS diseases; A PET and postmortem study
Region
| Japan |
Condition
Condition
Traumatic brain injury, CNS infectious diseases, Autoimmune encephalitis, Epilepsy, Chemical brain injury, Neurosurgery
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the pathomechanisms of secondary tauopathy following various CNS diseases especially focusing on chronic neuroinflammation and tau accumulation
Basic objectives2
Others
Basic objectives -Others
To elucidate the association of regional tau accumulation and MAO-B density with clinical symptoms following CNS injury
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regional MAO-B density quantified by PET with 11C-SL25.1188 in patients and healthy volunteers
Key secondary outcomes
Regional tau accumulation quantified by PET with 18F-florzolotau in patients and healthy volunteers
Quantity and distribution of tau pathology assessed by histopathology and autoradiography
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
Neuroimaging assessment including PET scans
Interventions/Control_2
Neuropsychological tests
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
Patients diagnosed with traumatic brain injury, CNS infectious diseases, autoimmune encephalitis, epilepsy, chemical brain injury, or after neurosurgery.
The diagnostic criteria for each disease shall be as follows
Traumatic brain injury, CNS infectious diseases, autoimmune encephalitis, chemical brain injury: Patients with a history of traumatic brain injury, CNS infection, autoimmune encephalitis, or chemical brain injury confirmed by medical history
Epilepsy: patients who meet the diagnostic criteria of the Epilepsy Clinical Practice Guidelines 2018
Patients who have undergone neurosurgery: those whose medical history confirms a history of neurosurgery
Healthy volunteers
Those who have the ability to give consent to participate in this study, and who can read and understand the consent explanatory document.
Key exclusion criteria
Patients group
1 Patients receiving dialysis
2 Patients who have or have had complications of serious physical diseases and are considered to be unsuitable for this study
3 Patients with severe claustrophobia
4 Pregnant, possibly pregnant, or lactating patients
5 Patients who are participating in other clinical trials, including clinical trials, research to which the Clinical Research Act applies or research to which ethical guidelines apply.
6 Patients within 3 months of blood donation
7 Allergic to local anesthetics or anticoagulants
8 Patients taking anticoagulants
9 Patients taking MAO-B inhibitors
10 Patients who regularly use health products with curcumin as an active ingredient
11 Patients who are unable to undergo MRI scanning
12 Others who are considered to be inappropriate as research subjects by the researcher
Normal volunteers
1 Persons with a history of or complications from organic brain disease (disorders of consciousness, head trauma requiring hospitalizat cerebral hemorrhage, etc.)
2 Persons with substance-related disorders (drug dependence, etc.)
3 Persons undergoing dialysis
4 Persons who have or have had complications of serious physical diseases and are considered to be unsuitable for this study
5 Persons with severe claustrophobia
6 Pregnant, possibly pregnant, or lactating persons
7 Persons who are participating in other clinical trials, including clinical trials, research to which the Clinical Research Act applies, or research to which ethical guidelines apply.
8 Persons within 3 months of blood donation
9 Allergic to local anesthetics or anticoagulants
10 Persons taking anticoagulants
11 Persons taking MAO-B inhibitors
12 Persons who regularly use health products with curcumin as an active ingredient
13 Persons who are unable to undergo MRI scanning
14 Others who are considered to be inappropriate as research subjects by the researcher
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Takahata |
Organization
National Institutes for Quantum Science and Technology
Division name
Advanced Neuroimaging Center, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
TEL
043-206-3251
takahata.keisuke@qst.go.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Takahata |
Organization
National Institutes for Quantum Science and Technology
Division name
Advanced Neuroimaging Center, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
TEL
043-206-3251
Homepage URL
takahata.keisuke@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Neurology and Psychiatry, Brain Research Institute Niigata University, National Hospital Oganizetion Simofusa Psychiatric Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
Tel
0432063025
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
国立研究開発法人 量子科学技術研究開発機構 量子医科学研究所(東京都)、国立精神・神経医療研究センター(東京都)、新潟大学脳研究所(新潟県)、下総精神医療センター(千葉県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 12 | 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
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062374
