UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053262 |
|---|---|
| Receipt number | R000060793 |
| Scientific Title | Longitudinal investigation for alpha-synuclein accumulation using PET ligand [18F] SPAL-T-06 in patients with multiple system atrophy |
| Date of disclosure of the study information | 2024/01/04 |
| Last modified on | 2024/01/04 15:25:40 |
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Basic information
Public title
Longitudinal investigation for alpha-synuclein accumulation using PET ligand [18F] SPAL-T-06 in patients with multiple system atrophy
Acronym
Longitudinal investigation for alpha-synuclein accumulation using PET ligand [18F] SPAL-T-06 in patients with multiple system atrophy
Scientific Title
Longitudinal investigation for alpha-synuclein accumulation using PET ligand [18F] SPAL-T-06 in patients with multiple system atrophy
Scientific Title:Acronym
Longitudinal investigation for alpha-synuclein accumulation using PET ligand [18F] SPAL-T-06 in patients with multiple system atrophy
Region
| Japan |
Condition
Condition
Multiple system atrophy (MSA)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to quantitatively assess the distribution of alpha-synuclein lesions in the brain in healthy volunteers and patients with multiple system atrophy (MSA) by PET using the radioligand [18F] SPAL-T-06 and to assess their longitudinal changes.
Basic objectives2
Others
Basic objectives -Others
To elucidate the pathological basis of the disease and its clinical manifestations by quantifying the distribution of alpha-synuclein lesions and their changes over time.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The distribution of alpha-synuclein lesions in the brain in healthy volunteers and patients with multiple system atrophy (MSA)
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 with [18F] SPAL-T-06, [11C] PiB, and neuropsychological tests
Interventions/Control_2
PET with [18F] SPAL-T-06, [11C] PiB, and 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
I. Patients
20 y.o.<=Age patients with multiple system atrophy (Gilman's criteria or MDS MSA criteria).
II. Healthy volunteers
20 y.o.<=Age normal subjects
Key exclusion criteria
I. Patients
1. Subjects with a history or complications of cerebral diseases
2. Subjects with concomitant substance use disorders
3. Subjects with a history or complications of severe diseases
4. Subjects with magnetic metals in the body
5. Subjects with severe claustrophobia
6. Pregnant women
7. Subjects who are considered to be inappropriate to participate in the study
II. Healthy volunteers
1. Subjects with a history or complications of cerebral diseases
2. Subjects with concomitant substance use disorders
3. Subjects with a history or complications of severe diseases
4. Subjects with magnetic metals in the body
5. Subjects with severe claustrophobia
6. Pregnant women
7. Subjects who are considered to be inappropriate to participate in the study
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Endo |
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology (QST)
Division name
Department of Functional Brain Imaging
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
+81-43-206-3251
endo.hironobu@qst.go.jp
Public contact
Name of contact person
| 1st name | Endo |
| Middle name | |
| Last name | Hironobu |
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, QST
Division name
Department of Functional Brain Imaging
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
+81-43-206-3251
Homepage URL
endo.hironobu@qst.go.jp
Sponsor or person
Institute
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology (QST)
Institute
Department
Personal name
Funding Source
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology (QST)
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 Institiutes for Quantum and Radiological Sciences and Technology
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
Tel
+81-43-206-4706
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
| 2024 | Year | 01 | Month | 04 | 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
| 2023 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 10 | 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 | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060793
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