Blood, Urine and Stool Markers to Tell Parkinson's Disease from Related Conditions
Looks for body-sample markers separating Parkinson's disease from atypical parkinsonian syndromes in adults.
Plain-language title generated from the registry record
Registry title: Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
Key facts
- Where
- Warsaw, PolandSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 to 80 with new parkinsonism (slowness of movement plus stiffness and/or resting tremor) and an abnormal DaTscan. It also enrols healthy controls.
- Age
- 40 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Suspected Parkinson's disease or atypical parkinsonian syndrome, with symptoms for less than 3 years.
- Earlier treatment
- No antibiotics or probiotics in the 3 months before the study visit.
- Biomarker or test result
- An abnormal dopamine transporter SPECT scan (DaTscan) showing loss of dopamine nerve cells.
Main reasons for not taking part
- Parkinsonism caused by another illness or by drugs
- Other brain disorders that could explain the symptoms, such as tumours or vascular problems
- Active cancer, infection or autoimmune inflammatory disease
- Severe heart, kidney, liver disease or poorly controlled diabetes
- Known single-gene mutation causing parkinsonism, pregnancy or breastfeeding
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT07604883, who can take part
Where in Poland
- Department of Neurology, CMKP Prof. Witold Orłowski Clinical Hospital, WarsawWarsaw, PolandNo longer taking part
- Department of Neurology, Faculty of Health Sciences, Medical University of WarsawWarsaw, PolandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- International Institute of Molecular and Cell Biology in Warsaw
- Trial code
- NCT07604883
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Antibiotic therapy or use of probiotics within 3 months prior to the study visit; 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; Pregnancy or breastfeeding.