UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057563 |
|---|---|
| Receipt number | R000065769 |
| Scientific Title | Association Between Proteinopathy-Associated Ligands, Underlying Pathophysiology, and Clinical Symptoms in Neuropsychiatric Disorders |
| Date of disclosure of the study information | 2025/04/09 |
| Last modified on | 2025/04/09 13:33:40 |
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Basic information
Public title
Association Between Proteinopathy-Associated Ligands, Underlying Pathophysiology, and Clinical Symptoms in Neuropsychiatric Disorders
Acronym
Exploratory Research on Proteinopathy-Associated Ligands
Scientific Title
Association Between Proteinopathy-Associated Ligands, Underlying Pathophysiology, and Clinical Symptoms in Neuropsychiatric Disorders
Scientific Title:Acronym
Exploratory Research on Proteinopathy-Associated Ligands
Region
| Japan |
Condition
Condition
Mild cognitive impairment, Alzheimer's disease, basal ganglia syndrome, progressive supranuclear palsy, frontotemporal lobar degeneration, Parkinson's disease, Lewy body dementia, idiopathic normal pressure hydrocephalus, multiple system atrophy, central nervous system injury, senile mental disorder
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the relationship between the underlying pathological basis and clinical manifestations of psychiatric and neurological diseases by performing radioligand-based PET studies to quantitatively evaluate the distribution of protein lesions in these diseases, as well as to evaluate the distribution of these lesions and clinical manifestations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative evaluation of the distribution of [18F]C05-05, [18F]SPAL-T-06, [18F]florzolotau and [11C]PiB in the studied patients and healthy volunteers and their association with 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with psychiatric and neurodegenerative disorders
Patients who are at least 18 years of age at the time consent is obtained.
Patients who are able to be accompanied on the day of study participation in QST by a potential surrogate if consent by the patient is difficult to obtain.
Patients who meet the diagnostic criteria for each disease.
2.Patients with central nervous system injury
Patients who are at least 18 years old at the time of consent.
Patients must be able to understand the study outline at the time of consent.
Patients with a history of CNS injury that can be confirmed by medical history.
3.Healthy volunteers
Healthy volunteers who are at least 18 years old at the time of consent.
Healthy adults who have been examined by a physician who is a researcher and judged to be eligible for this study.
Key exclusion criteria
1) Subjects with psychiatric and neurodegenerative disorders
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. Those with a history of allergic reactions to local anesthetics or heparin (only for arterial blood sampling).
7. Subjects who are taking anticoagulants (only for arterial blood sampling).
8. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
2) Subjects with traumatic brain injury
1. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
2. Subjects with claustrophobia
3. Pregnant, possibly pregnant or lactating women
4. Those with a history of allergic reactions to local anesthetics or heparin (only for arterial blood sampling).
5. Subjects who are taking anticoagulants (only for arterial blood sampling).
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 magnetic metals in their bodies (tattoos, tattoos including art makeup, pacemakers, etc.).
5. Subjects with claustrophobia
6. Pregnant, possibly pregnant or lactating women
7. Those with a history of allergic reactions to local anesthetics or heparin (only for arterial blood sampling).
8. Subjects who are taking anticoagulants (only for arterial blood sampling).
9. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
Target sample size
325
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Endo |
Organization
Institute for Quantum Medical Science, National Institutes for Quantum Science and Technology
Division name
Advanced Neuroimaging Center
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba-ken, Japan
TEL
0432063249
endo.hironobu@qst.go.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Endo |
Organization
Institute for Quantum Medical Science, National Institutes for Quantum Science and Technology
Division name
Advanced Neuroimaging Center
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba-ken, Japan
TEL
0432063249
Homepage URL
endo.hironobu@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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board, National Institutes for Quantum Science and Technology
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba-ken, Japan
Tel
043-206-4706
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
| 2025 | Year | 04 | Month | 09 | 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
| 2025 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065769
