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.
Study Type
OBSERVATIONAL
Enrollment
200
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
Differential expression of selected microRNAs
Identification of microRNA in peripheral blood enabling the differentiation of PD and APS at an early stage of the disease.
Time frame: 18 months
Differences in metabolomic profiles
Identification of metabolomic profiles in peripheral blood enabling the early differentiation between PD and APS.
Time frame: 18 months
Ability of biomarkers to differentiate PD and APS
Assessing the diagnostic accuracy of biomarkers in differentiating PD from APS-analysis of receiver operating characteristic curves.
Time frame: 18 months
Changes in molecular (miRNA, metabolomic) profiles over time
Longitudinal analysis comparing molecular characteristics assessed at two distinct time points: T0 (baseline clinical visit) and T2 (follow-up assessment conducted 12-18 months later).
Time frame: 18 months
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