UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061168 |
|---|---|
| Receipt number | R000069982 |
| Scientific Title | Longitudinal assessment of brain synaptic function in neurological and psychiatric disorders using PET ligands targeting synaptic molecules |
| Date of disclosure of the study information | 2026/04/06 |
| Last modified on | 2026/04/06 11:30:54 |
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Basic information
Public title
Longitudinal study of brain synaptic function and symptom changes in neurological and psychiatric disorders
Acronym
Synaptic PET Longitudinal Study
Scientific Title
Longitudinal assessment of brain synaptic function in neurological and psychiatric disorders using PET ligands targeting synaptic molecules
Scientific Title:Acronym
Synaptic PET Longitudinal Study
Region
| Japan |
Condition
Condition
Dementia-related disorders: Mild cognitive impairment (MCI), Alzheimer's disease (AD), Frontotemporal lobar degeneration, Chronic traumatic encephalopathy (CTE)
Movement disorders: Dystonia, Parkinsonism (PD, DLB, PSP, CBS, etc.), Essential tremor
Epilepsy
Psychiatric disorders: Mood disorders (Bipolar disorder, Major depressive disorder), Schizophrenia, Obsessive-compulsive disorder, Anxiety disorders
Healthy volunteers
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to longitudinally evaluate changes in brain synaptic function in patients with neurological and psychiatric disorders using positron emission tomography (PET) with radiolabeled ligands targeting synaptic molecules, and to elucidate their associations with clinical symptoms, MRI indices, and blood biomarkers.
Basic objectives2
Others
Basic objectives -Others
In many neurological and psychiatric disorders, the structural and functional disruption of brain networks underlies the core pathophysiology. In particular, reductions in synaptic density and abnormalities in excitatory neurotransmission mediated by glutamate are thought to play critical roles in the onset and progression of cognitive impairment, psychiatric symptoms, and movement disorders. In the present study, we employ four PET ligands - [11C]UCB-J, [18F]EST-604, [11C]ABP688, and [11C]K-2 - to comprehensively assess brain synaptic function, to elucidate disease-spanning pathophysiological mechanisms, and intraindividual changes in neural function over time.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution and density of synaptic function-related proteins (SV2A, mGlu2/3 receptors, mGlu5 receptor, and AMPA receptor) in healthy controls and patient groups, as quantified by binding indices derived from PET imaging (e.g., BP_ND, V_T, and SUVR).
Key secondary outcomes
(1) Longitudinal changes in the distribution and density of the aforementioned synaptic function-related proteins in healthy controls and patient groups (follow-up comparison).
(2) Associations and correlations between PET quantitative indices and clinical symptom scores, MRI measures (gray matter volume, diffusion tensor indices, resting-state functional connectivity, etc.), and blood biomarkers.
(3) Comparisons of synaptic function indices across disease groups.
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
5
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET scanning: Two of the following four synaptic radioligands are selected based on disease and ligand characteristics and administered to patient groups, healthy volunteers receive up to three ligands to minimize radiation exposure.
[11C]UCB-J
[18F]EST-604
[11C]ABP688
[11C]K-2
Interventions/Control_2
Brain MRI (T1-weighted, T2-weighted, resting-state fMRI, and DTI)
Interventions/Control_3
Clinical symptom assessment using neuropsychological testing
Interventions/Control_4
Blood sampling
Interventions/Control_5
Follow-up examinations performed at least 6 months after completion of the initial assessment.
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
Patient group
Participants must have the capacity to provide informed consent and be able to read and understand the informed consent document. In cases where the patient lacks decision-making capacity, a legally authorized representative must be able to accompany them on the day of study participation at QST.
Aged 18 years or older at the time of informed consent.
Patients diagnosed with one of the following conditions: dementia-related disorders (mild cognitive impairment, Alzheimer's disease, frontotemporal lobar degeneration, chronic traumatic encephalopathy), movement disorders (dystonia, Parkinsonism, essential tremor), epilepsy, or psychiatric disorders (mood disorders, schizophrenia, obsessive-compulsive disorder, anxiety disorders).
Diagnostic criteria for each condition are as follows:
1 MCI: Patients meeting the Petersen diagnostic criteria
2 AD: Patients meeting the NINCDS-ADRDA diagnostic criteria
3 Frontotemporal lobar degeneration
4 Chronic traumatic encephalopathy
5 Dystonia
6 Parkinsonism
7 Essential tremor
8 Epilepsy
9 Mood disorders
10 Schizophrenia
11 Obsessive-compulsive disorder
12 Anxiety disorders
Healthy volunteer group
Aged 18 years or older at the time of informed consent.
Healthy individuals who have the capacity to provide informed consent and are able to read and understand the informed consent document.
Key exclusion criteria
Patient group
1. Individuals with organic brain disorders (e.g., disturbance of consciousness, head trauma requiring hospitalization, or evident cerebral infarction or hemorrhage)
2. Individuals with comorbid substance-related disorders (e.g., drug dependence)
3. Individuals with severe comorbid medical conditions, or those with a history of such conditions, who are judged by the investigator to be inappropriate for participation in this study
4. Individuals with severe claustrophobia
5. Individuals who are pregnant, possibly pregnant, or breastfeeding
6. Individuals judged by the investigator to be unsuitable as study participants for any other reason
Healthy volunteer group
1. Individuals with organic brain disorders (e.g., disturbance of consciousness, head trauma requiring hospitalization, or evident cerebral infarction or hemorrhage)
2. Individuals with substance-related disorders (e.g., drug dependence)
3. Individuals with severe comorbid medical conditions, or those with a history of such conditions, who are judged by the investigator to be inappropriate for participation in this study
4. Individuals with pacemakers or metallic implants (e.g., intracranial clips, bolts)
5. Individuals with tattoos (including cosmetic tattoos or permanent makeup)
6. Individuals with severe claustrophobia
7. Individuals who are pregnant, possibly pregnant, or breastfeeding
8. Individuals judged by the investigator to be unsuitable as study participants for any other reason
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Yamamoto |
Organization
National Institutes for Quantum Science and Technology,
Institute for Quantum Medical Science
Division name
Advanced Neuroimaging Center
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL
043-206-3251
yamamoto.yasuharu@qst.go.jp
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Yamamoto |
Organization
National Institutes for Quantum Science and Technology, Institute for Quantum Medical Science
Division name
Advanced Neuroimaging Center
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL
043-206-3251
Homepage URL
yamamoto.yasuharu@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology, Institute for Quantum Medical Science
Institute
Department
Personal name
Yasuharu Yamamoto
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of National Institutes for Quantum Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, 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
| 2026 | Year | 04 | Month | 06 | 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
| 2026 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2033 | 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
| 2026 | Year | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069982
