UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062921 |
|---|---|
| Receipt number | R000072039 |
| Scientific Title | Study of Associations Between Dementia-Related Blood Biomarkers Measured Using General-Purpose Immunoassay Platforms and Existing Clinical Data |
| Date of disclosure of the study information | 2026/09/14 |
| Last modified on | 2026/09/14 16:49:58 |
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Basic information
Public title
Study of Associations Between Dementia-Related Blood Biomarkers Measured Using General-Purpose Immunoassay Platforms and Existing Clinical Data
Acronym
Dementia Biomarker Study Using General-Purpose Immunoassay Platforms
Scientific Title
Study of Associations Between Dementia-Related Blood Biomarkers Measured Using General-Purpose Immunoassay Platforms and Existing Clinical Data
Scientific Title:Acronym
Dementia Biomarker Study Using General-Purpose Immunoassay Platforms
Region
| Japan |
Condition
Condition
Alzheimer's disease, mild cognitive impairment, frontotemporal lobar degeneration, Lewy body disease (Parkinson's disease and dementia with Lewy bodies), progressive supranuclear palsy, corticobasal syndrome, multiple system atrophy, other neurodegenerative diseases, and healthy controls
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure blood biomarkers expected to reflect dementia-related pathology using the general-purpose immunoassay analyzers ARCHITECT and Alinity; to examine their associations with existing clinical diagnoses, cognitive assessments, imaging findings, and biomarker data obtained using Simoa and other methods; and to evaluate agreement and correlations with existing data and the potential for clinical laboratory implementation.
Basic objectives2
Others
Basic objectives -Others
Evaluation of measurement validity and potential clinical implementation of diagnostic biomarkers
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlations between newly obtained blood biomarker measurements using general-purpose immunoassay analyzers and existing clinical diagnostic information, imaging findings (amyloid, tau, and synuclein PET), or existing biomarker data
Key secondary outcomes
Correlations between biomarker measurements and existing neuropsychological assessments; differences in measurement distributions among disease groups; potential stratification using combinations of biomarkers; and correlations between measurements and clinical course when existing longitudinal data are available
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
Individuals who participated in an existing study at QST by July 31, 2026, have stored blood samples, and have not refused secondary use of their samples and information.
Key exclusion criteria
1. The participant or legally authorized representative has refused secondary use of the samples or information. 2. The principal investigator determines that sample quality is unsuitable for measurement. 3. The minimum sample volume required for measurement is unavailable. 4. Existing information required for analysis has major missing data.
Target sample size
1000
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
Advanced Neuroimaging Center, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba, 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
Advanced Neuroimaging Center, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba, 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
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Abbott Japan LLC
Name of secondary funder(s)
National Institutes for Quantum Science and Technology; Abbott Japan LLC
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
Tel
043-206-4706
helsinki@qst.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
N26-022
Org. issuing International ID_1
National Institutes for Quantum Science and Technology
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立研究開発法人量子科学技術研究開発機構（千葉県）、アボットジャパン合同会社（千葉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 14 | 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
No
IPD sharing Plan description
Individual participant-level data will not be shared because this study uses existing samples and information and individual-level samples and data will not be provided outside QST. Only statistically processed aggregate results will be shared with Abbott Japan LLC.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2027 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a retrospective observational study using existing samples and information. No new blood collection, cerebrospinal fluid collection, imaging examination, or other intervention or invasive procedure will be performed for this study. An opt-out period will be provided through April 30, 2027, and samples and information from individuals who have not refused use will be included.
Management information
Registered date
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072039
