UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059577 |
|---|---|
| Receipt number | R000068126 |
| Scientific Title | PET studies on synaptic function alterations in neurological disorders |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/10/29 11:41:21 |
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Basic information
Public title
PET studies on synaptic function alterations in neurological disorders
Acronym
PET assessment of synaptic function in neurological disorders
Scientific Title
PET studies on synaptic function alterations in neurological disorders
Scientific Title:Acronym
PET assessment of synaptic function in neurological disorders
Region
| Japan |
Condition
Condition
Healthy subjects, and patients diagnosed with occlusion or stenosis of the major cerebral arteries, neuroinflammatory disorders, neurodegenerative disorders, vascular dementia, and epilepsy
Classification by specialty
| Neurology | Vascular surgery | Pediatrics |
| Psychiatry | Radiology | Neurosurgery |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate changes in the pathology and pathophysiology of cerebrovascular disorders, neuroinflammatory diseases, and neurodegenerative diseases with respect to synaptic function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantitative indicators such as SUVR obtained from synaptic function PET
Key secondary outcomes
Structural changes in the brain, volumes of grey matter, white matter, etc., axonal and myelin function, as determined by MRI. Cerebral circulatory metabolism, as determined by O-15 PET.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Subjects shall have an intravenous access route established in an upper limb vein using either a hypodermic needle or an indwelling needle, and receive a single intravenous dose of [18F]SynVesT-1 at 3.7 MBq/kg (minimum dose 111 MBq, maximum dose 370 MBq).
Interventions/Control_2
Head PET imaging is performed for approximately 20 minutes, commencing 60 minutes after administration.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals from whom written consent for study participation has been obtained
Healthy subjects aged 20 to 60 years without brain or neurological disorders
Key exclusion criteria
Pregnant or breastfeeding individuals
Individuals with gross organic brain abnormalities
Other individuals deemed unsuitable by the principal investigator or co-investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kayako |
| Middle name | |
| Last name | Isohashi |
Organization
The University of Osaka
Division name
Department of Nuclear Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3434
isohashi.kayako.med@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Katayama |
Organization
The University of Osaka
Division name
Department of Nuclear Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3434
Homepage URL
katayama.daisuke.med@osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
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
The University of Osaka
Address
2-2 Yamadaoka, Suita City, Osaka
Tel
06-6879-3434
isohashi.kayako.med@osaka-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
| 2025 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 20 | 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 | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068126
