Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07604883

Acronym

BIOMARK-PS

Enrollment

200

Registered

2026-05-22

Start date

2026-06-04

Completion date

2029-06-04

Last updated

2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical Parkinsonism, Dementia With Lewy Bodies (DLB), Multiple System Atrophy, PARKINSON DISEASE (Disorder), Progressive Supranuclear Palsy (PSP)

Keywords

parkinson disease, atypical parkinsonism, progressive supranuclear palsy, multiple system atrophy, dementia with lewy bodies, biomarker

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Patients with suspected neurodegenerative parkinsonism in the course of PD or APS, defined according to the 2015 MDS criteria as bradykinesia accompanied by at least one additional symptom: rigidity and/or resting tremor. Age between 40 and 80 years. Written informed consent for participation in the study. Duration of parkinsonian symptoms shorter than 3 years. Abnormal dopamine transporter single-photon emission computed tomography (DaTscan) result confirming presynaptic dopaminergic neuronal degeneration.

Exclusion criteria

Lack of consent to participate in the study. Secondary or drug-induced parkinsonism. Other central nervous system (CNS) disorders (e.g., neoplastic or vascular processes) that could account for the symptoms. Active malignancy, infection, or autoimmune inflammatory disease. Severe systemic diseases, including advanced heart failure (New York Heart Association \[NYHA\] class III-IV), poorly controlled diabetes mellitus, renal failure with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m², or hepatic failure. Presence of a known monogenic mutation causing parkinsonism according to the Online Mendelian Inheritance in Man (OMIM) classification. Antibiotic therapy or use of probiotics within 3 months prior to the study visit. Pregnancy or breastfeeding.

Design outcomes

Primary

Measure	Time frame	Description
Differential expression of selected microRNAs	18 months	Identification of microRNA in peripheral blood enabling the differentiation of PD and APS at an early stage of the disease.
Differences in metabolomic profiles	18 months	Identification of metabolomic profiles in peripheral blood enabling the early differentiation between PD and APS.

Secondary

Measure	Time frame	Description
Ability of biomarkers to differentiate PD and APS	18 months	Assessing the diagnostic accuracy of biomarkers in differentiating PD from APS-analysis of receiver operating characteristic curves.
Changes in molecular (miRNA, metabolomic) profiles over time	18 months	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).

Countries

Poland

Contacts

CONTACTJacek Kuźnicki, Professor

jacek.kuznicki@iimcb.gov.pl+48 22 5970700

PRINCIPAL_INVESTIGATORJacek Kuźnicki

The International Institute of Molecular and Cell Biology in Warsaw

Outcome results