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NOT YET RECRUITING
NCT07604883

Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes

Sponsor: International Institute of Molecular and Cell Biology in Warsaw

View on ClinicalTrials.gov

Summary

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.

Official title: Identification of Molecular Biomarkers, Including microRNAs and Metabolites, Enabling Early Differentiation of Parkinson's Disease and Atypical Parkinsonian Syndromes in a Prospective Observational Study.

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-06-04

Completion Date

2029-06-04

Last Updated

2026-05-28

Healthy Volunteers

Yes

Locations (2)

Department of Neurology, CMKP Prof. Witold Orłowski Clinical Hospital, Warsaw

Warsaw, Poland

Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw

Warsaw, Poland