UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062131 |
|---|---|
| Receipt number | R000071058 |
| Scientific Title | Validation of blood biomarkers for Lewy body disease through collaboration with international cohorts |
| Date of disclosure of the study information | 2026/07/07 |
| Last modified on | 2026/07/03 11:23:01 |
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Basic information
Public title
Validation study of blood biomarkers for Lewy body disease using international cohorts
Acronym
International LBD Blood Biomarker Study
Scientific Title
Validation of blood biomarkers for Lewy body disease through collaboration with international cohorts
Scientific Title:Acronym
LBD-BM International Validation Study
Region
| Japan |
Condition
Condition
Lewy body disease, including Parkinson's disease, dementia with Lewy bodies, and REM sleep behavior disorder, and related neurodegenerative disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to validate blood biomarkers, including the acetylated alpha-synuclein assay developed at QST, using existing samples and data from the QST cohort and international cohorts such as PPMI and BioFINDER, and to evaluate their ability to discriminate Lewy body disease, their associations with PET imaging findings, cerebrospinal fluid biomarkers and clinical severity, and their reproducibility across domestic and international cohorts.
Basic objectives2
Others
Basic objectives -Others
Validation of diagnostic accuracy and clinical utility of blood biomarkers using existing samples and data
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discriminative performance of blood biomarker levels, including Ac-alpha-syn, measured in existing samples for Lewy body disease. The primary assessment will include ROC-AUC, sensitivity, and specificity for distinguishing Lewy body disease, including Parkinsons disease or dementia with Lewy bodies, from non-Lewy body disease, including Alzheimers disease and healthy controls.
Key secondary outcomes
1. Associations between blood biomarker levels and PET imaging findings, including amyloid, tau, and alpha-synuclein PET
2. Associations between blood biomarker levels and cerebrospinal fluid biomarker levels
3. Associations between blood biomarker levels and clinical severity measures, including MDS-UPDRS, MMSE, and MoCA
4. Reproducibility of blood biomarker levels and diagnostic performance across the QST, PPMI, and BioFINDER cohorts
5. Diagnostic performance of combinations of multiple blood biomarkers
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Existing samples and data meeting either of the following criteria will be included:
1. Patients with dementia-related disorders or healthy volunteers who participated in existing QST studies, have stored blood samples at QST, and have at least one available dataset among PET, MRI, or neuropsychological assessment data. Target conditions include Parkinsons disease, dementia with Lewy bodies, Alzheimers disease, frontotemporal lobar degeneration, progressive supranuclear palsy, corticobasal syndrome, multiple system atrophy, REM sleep behavior disorder, mild cognitive impairment, and healthy controls.
2. Participants enrolled in PPMI or BioFINDER whose sample provision for this study has been approved by the sample access committee or equivalent body of each cohort.
Key exclusion criteria
1. For the QST cohort, individuals who refuse secondary use of their samples or data through the opt-out procedure for this study.
2. Samples or data judged by QST investigators to be unsuitable for measurement because of sample quality, freeze-thaw history, storage duration, hemolysis, or other relevant factors.
3. For international cohorts, samples or data for which withdrawal of sample or data provision occurs according to the rules of each cohort, or samples judged to be unsuitable for measurement because of sample quality.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tagai |
Organization
National Institutes for Quantum Science and Technology
Division name
Institute for Quantum Medical Science, Brain Function Imaging Research Center
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL
043-206-3251
tagai.kenji@qst.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Tagai |
Organization
National Institutes for Quantum Science and Technology
Division name
Institute for Quantum Medical Science, Brain Function Imaging Research Center
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL
043-206-3251
Homepage URL
tagai.kenji@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Clinical Research Review Board, National Institutes for Quantum Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
Tel
043-382-3703
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 | 07 | Month | 07 | 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
| 2026 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2026 | Year | 07 | Month | 03 | Day |
Last modified on
| 2026 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071058
