Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes (BIOMARK-PS)

May 25, 2026 updated by: Jacek Kuznicki, International Institute of Molecular and Cell Biology in Warsaw

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

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland, 03-242
        • Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw
        • Contact:
      • Warsaw, Poland, 00-416
        • Department of Neurology, CMKP Prof. Witold Orłowski Clinical Hospital, Warsaw
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients with suspected neurodegenerative parkinsonism associated with PD or APS, diagnosed according to the MDS 2015 criteria. Eligible participants must present with bradykinesia accompanied by at least one additional cardinal motor symptom, including rigidity and/or resting tremor. Patients aged between 40 and 80 years, with a duration of parkinsonian symptoms shorter than 3 years, and an abnormal DaTscan confirming presynaptic dopaminergic neuronal degeneration will be included. All participants must provide written informed consent prior to enrollment.

Participants will be excluded if they have secondary or drug-induced parkinsonism, other central nervous system disorders that could explain parkinsonian symptoms (including neoplastic or vascular conditions), active malignancy, infection, or autoimmune inflammatory disease.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of clinical predictors of atypical parkinsonian syndrome development.
Time Frame: 18 months

Comprehensive clinical characterization of participants at baseline (T0) and follow-up (T2) to identify clinical features associated with PD and APS, and to support final diagnostic classification according to Movement Disorder Society (MDS) criteria.

At the baseline visit (T0), detailed clinical data will be collected, including the severity of motor symptoms assessed using the MDS-UPDRS scale in both ON and OFF states (following a 12-hour withdrawal of dopaminergic medication), as well as non-motor symptoms evaluated with the MDS-NMS, RBDSQ, and GIDS-PD scales. Demographic data, family history of neurological disorders, and information regarding known PD-associated genetic mutations will also be recorded. Cognitive function and mood disturbances will be assessed using the MoCA, Beck Depression Inventory, Beck Anxiety Inventory, and Frontal Assessment Battery. In all patients examined in the OFF state, blood pressure and heart rate.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Institute of Molecular and Cell Biology in Warsaw

Collaborators

Medical University of Warsaw
Medical Centre for Postgraduate Education

Investigators

  • Principal Investigator: Jacek Kuźnicki, The International Institute of Molecular and Cell Biology in Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 4, 2026

Primary Completion (Estimated)

January 4, 2029

Study Completion (Estimated)

June 4, 2029

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/40/2026 (Other Identifier: Medical University of Warsaw Bioethical Comittee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

OSF, anonymised laboratory and clinical data of participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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