UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056815 |
|---|---|
| Receipt number | R000064937 |
| Scientific Title | Imaging Study of Mitochondrial Function in Multiple System Atrophy |
| Date of disclosure of the study information | 2025/01/27 |
| Last modified on | 2026/01/26 12:30:26 |
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Basic information
Public title
Imaging Study of Mitochondrial Function in Multiple System Atrophy
Acronym
Imaging Study of Mitochondrial Function in Multiple System Atrophy
Scientific Title
Imaging Study of Mitochondrial Function in Multiple System Atrophy
Scientific Title:Acronym
Imaging Study of Mitochondrial Function in Multiple System Atrophy
Region
| Japan |
Condition
Condition
[18F]FDG-PET and [18F]BCPP-EF-PET will be performed on MSA patients and age-matched healthy controls to elucidate the pathophysiology of MSA.
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
[18F]FDG-PET and [18F]BCPP-EF-PET will be performed on MSA patients and age-matched healthy controls to elucidate the pathophysiology of MSA.
Basic objectives2
Others
Basic objectives -Others
Nuclear medicine imaging will be used to analyze regional variations and differences in the uptake of FDG and BCPP-EF within and between MSA patients and healthy controls across different brain regions, thereby elucidating functional abnormalities in the brain of MSA patients. Furthermore, by examining the correlation between these PET imaging findings, MRI data, and the severity of system-specific clinical symptoms, it will be possible to clarify their associations with the manifestation of each symptom.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological Characteristics of [18F]BCPP-EF PET and [18F]FDG PET Imaging in MSA Patients Compared to Healthy Controls
Key secondary outcomes
Association Between [18F]BCPP-EF PET and [18F]FDG PET Imaging and the Severity of Clinical Symptoms in MSA
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For MSA patients, adults will be included without restrictions on age or sex. Healthy controls will have no sex restrictions, but their age will be limited to 40 years or older, as MSA predominantly occurs in this age group.
MSA patients must meet the criteria for Clinically Established MSA or Clinically Probable MSA based on the 2022 guidelines published by the Movement Disorder Society (16).
Healthy controls must be fully independent in their activities of daily living, have no history of psychiatric or neurological disorders, and have no abnormal brain MRI findings that would render them unsuitable for participation in this study, as determined by the principal investigator or co-investigators. MSA patients must not present with MRI abnormalities that would deem them unsuitable for this study, apart from the characteristic changes associated with MSA.
Key exclusion criteria
The presence of any disease, mental condition, or abnormal test findings that may interfere with participation in the study, as determined by the principal investigator.
A history of hypersensitivity to [18F]BCPP-EF, [18F]FDG, or any of their components.
Women for whom pregnancy cannot be ruled out based on medical history.
Presence of a cardiac pacemaker.
Presence of metallic implants in the body for which non-magnetic properties cannot be confirmed (e.g., cerebral aneurysm clips, mechanical heart valves, neurostimulators, insulin pumps, intraocular metal fragments, etc.).
Severe communication difficulties that prevent the participant from reporting abnormalities during imaging.
Poor general health condition, such as abnormal vital signs.
Inability to safely discontinue medications that affect glucose metabolism or mitochondrial function.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Nakanishi |
Organization
Kyoto University Hospital
Division name
Neulorogy
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyoku, kyoto
TEL
075-751-4748
ctsodan@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Etsuro |
| Middle name | |
| Last name | Nakanishi |
Organization
Kyoto University Hospital
Division name
Clinical Research Consultation Desk
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyoku, kyoto
TEL
075-751-4748
Homepage URL
ctsodan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED, MSA Coalition research grant
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
konoecho,yoshida, sakyo-ku, kyoto
Tel
075-753-4642
ethcom@kuhp.kyoto-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 | 01 | Month | 27 | 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
| 2025 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nuclear medicine imaging will be used to analyze regional variations and differences in the uptake of FDG and BCPP-EF within and between MSA patients and healthy controls across different brain regions, thereby elucidating functional abnormalities in the brain of MSA patients. Furthermore, by examining the correlation between these PET imaging findings, MRI data, and the severity of system-specific clinical symptoms, it will be possible to clarify their associations with the manifestation of each symptom.
Management information
Registered date
| 2025 | Year | 01 | Month | 25 | Day |
Last modified on
| 2026 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064937
