Tokyo, July 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062131) titled 'Validation study of blood biomarkers for Lewy body disease using international cohorts' on July 7.

Study Type: Observational

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

Condition: Condition - Lewy body disease, including Parkinson's disease, dementia with Lewy bodies, and REM sleep behavior disorder, and related neurodegenerative disorders Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 2500

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071058

Disclaimer: Curated by HT Syndication.