Clinical Trial: Study of Associations Between Dementia-Related Blood Biomarkers Measured Using General-Purpose Immunoassay Platforms and Existing Clinical Data (Japan)

Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062921) titled 'Study of Associations Between Dementia-Related Blood Biomarkers Measured Using General-Purpose Immunoassay Platforms and Existing Clinical Data' on Sept. 14.

Study Type: Observational

Primary Sponsor: Institute - National Institutes for Quantum Science and Technology

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 malignancy - Others Genomic information - NO

Objective: 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

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 Size - 1000

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072039

Disclaimer: Curated by HT Syndication.