ClinicalTrials.gov record NCT07604883

Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age40 years old to 80 years old
SexAll
LocationPoland
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational study enrolling people with early parkinsonian symptoms (Parkinson's disease or atypical parkinsonism) and healthy controls. Participants give blood, urine, and stool samples at the first visit and again 12–18 months later. The study looks for molecular differences—including microRNAs and metabolites—that could help tell Parkinson's disease apart from atypical parkinsonian syndromes.

What it is studying. The study is testing whether molecular measurements (microRNA profiles, metabolomic patterns, RNA sequencing data, and microbiome features) in blood, urine, and stool differ between people with Parkinson's disease, people with atypical parkinsonian syndromes, and healthy controls. It also assesses whether combinations of these molecular markers can distinguish these conditions early and how these markers change over a 12–18 month period.

What the researchers hope to learn. Scientific goals: identify molecular biomarker signatures (microRNAs, metabolites, RNA, microbiome) that differentiate Parkinson's disease from atypical parkinsonian syndromes; evaluate diagnostic accuracy of biomarker panels; examine longitudinal changes in these markers.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants have a baseline clinical assessment and provide blood, urine, and stool samples, then return for a follow-up visit 12–18 months later for repeat assessments and samples. Collected samples will be analysed for molecular signatures (including microRNA profiling, metabolomics, RNA sequencing, and microbiome analysis). The study does not assign any treatments; it is observational and focused on identifying and comparing biomarkers over time.

How the study is structured. A prospective observational cohort study. Planned enrollment includes people with early parkinsonian symptoms and healthy control participants. Participants have clinical assessments and provide blood, urine, and stool at baseline and at a 12–18 month follow-up. Collected samples undergo molecular analyses (microRNA profiling, metabolomics, RNA sequencing, microbiome analysis) to compare groups and track changes over time.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Poland. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on progressive supranuclear palsy

This trial is also listed on this site under multiple system atrophy.

Clinical trials45 trials listed for progressive supranuclear palsyEvery trial the registry lists for progressive supranuclear palsy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in progressive supranuclear palsy researchLatest monthly update: September 2026. Includes: PSP vs Parkinsons. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 4, 2026 (estimated)
Primary completion
Jan 4, 2029 (estimated)
Study completion
Jun 4, 2029 (estimated)
Target enrollment
200 participants (estimated)
Last updated on registry
May 28, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
International Institute of Molecular and Cell Biology in Warsaw
Principal investigator
Jacek Kuznicki, Professor
International Institute of Molecular and Cell Biology in Warsaw
Collaborators
  • Medical University of Warsaw
  • Medical Centre for Postgraduate Education

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

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

    Warsaw, 00-416 · Poland

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

    Warsaw, 03-242 · Poland

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
Written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
glomerular filtration rate
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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