Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes

This prospective observational study aims to identify and preliminarily validate molecular biomarkers, including microRNAs and metabolites, for the early differentiation of Parkinson's disease (PD) from atypical parkinsonian syndromes (APS). The study will enroll up to 100 patients with PD, 50 patients with suspected APS, and 50 healthy controls. Participants will undergo clinical assessments and provide blood, urine, and stool samples at baseline and after 12-18 months of follow-up. Molecular analyses, including microRNA profiling, metabolomics, RNA sequencing (RNA-seq), and microbiome analysis, will be performed to identify disease-specific diagnostic signatures. The primary objective is to detect differences in molecular profiles among patients with PD, patients with APS, and healthy controls. Secondary objectives include evaluating the diagnostic accuracy of biomarker panels and assessing longitudinal changes in these biomarkers over time. Although participants will not receive direct therapeutic benefits, the study may contribute to the development of non-invasive tools for the early diagnosis and improved differentiation of parkinsonian disorders.

NCT Number	NCT07604883
Lead Sponsor	International Institute of Molecular and Cell Biology in Warsaw Collaborators: Medical University of Warsaw, Medical Centre for Postgraduate Education
Conditions	PARKINSON DISEASE (Disorder), Atypical Parkinsonism, Multiple System Atrophy, Progressive Supranuclear Palsy (PSP), Dementia With Lewy Bodies (DLB)
Enrollment	200 participants
Start Date	2026-06-04
Primary Completion	2029-01-04 (estimated)
Study Completion	2029-06-04 (estimated)
Updated on ClinicalTrials.gov	2026-05-28