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PARKINSON DISEASE (Disorder)BIOMARK-PSNCT07604883

Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes

An observational study of PARKINSON DISEASE (Disorder) and Atypical Parkinsonism, run by International Institute of Molecular and Cell Biology in Warsaw at 2 sites in Poland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
How many people
200 participants
Where
2 sitesPoland
Study dates
30 Oct 2026to 4 Jun 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Poland2 sites

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

    Warsaw, 00-416

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

    Warsaw, 03-242

Other trials in Poland

About this study

Official title: 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.

Read more

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.

Keywords
parkinson disease, atypical parkinsonism, progressive supranuclear palsy, multiple system atrophy, dementia with lewy bodies, biomarker
Medical subject headings
Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive, Lewy Body Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 18 months

  2. Differences in metabolomic profiles

    Identification of metabolomic profiles in peripheral blood enabling the early differentiation between PD and APS.

    Measured: 18 months

Secondary outcomes (2)

  1. 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.

    Measured: 18 months

  2. 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).

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion4 Jan 2029 (estimated)
  4. Study completion4 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07604883
Sponsor's protocol ID
KB/40/2026
Other IDs
KB/40/2026
Acronym
BIOMARK-PS
Status last verified
Nov 2026
First submitted
18 May 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: OSF, anonymised laboratory and clinical data of participants

Publications

  • Chen L, Chen J, Weng W, Wu M, Zhou X, Yan P. Bibliometric analysis of microRNAs and Parkinson's disease from 2014 to 2023. Front Neurol. 2024 Sep 25;15:1466186. doi: 10.3389/fneur.2024.1466186. eCollection 2024.

    PubMed 39385824

  • Eckert T, Tang C, Ma Y, Brown N, Lin T, Frucht S, Feigin A, Eidelberg D. Abnormal metabolic networks in atypical parkinsonism. Mov Disord. 2008 Apr 15;23(5):727-33. doi: 10.1002/mds.21933.

    PubMed 18186116

  • Trupp M, Jonsson P, Ohrfelt A, Zetterberg H, Obudulu O, Malm L, Wuolikainen A, Linder J, Moritz T, Blennow K, Antti H, Forsgren L. Metabolite and peptide levels in plasma and CSF differentiating healthy controls from patients with newly diagnosed Parkinson's disease. J Parkinsons Dis. 2014;4(3):549-560. doi: 10.3233/JPD-140389.

    PubMed 24927756

  • Khoo SK, Petillo D, Kang UJ, Resau JH, Berryhill B, Linder J, Forsgren L, Neuman LA, Tan AC. Plasma-based circulating MicroRNA biomarkers for Parkinson's disease. J Parkinsons Dis. 2012;2(4):321-31. doi: 10.3233/JPD-012144.

    PubMed 23938262

  • Margis R, Margis R, Rieder CR. Identification of blood microRNAs associated to Parkinsonis disease. J Biotechnol. 2011 Mar 20;152(3):96-101. doi: 10.1016/j.jbiotec.2011.01.023. Epub 2011 Feb 3.

    PubMed 21295623

  • Tolosa E, Garrido A, Scholz SW, Poewe W. Challenges in the diagnosis of Parkinson's disease. Lancet Neurol. 2021 May;20(5):385-397. doi: 10.1016/S1474-4422(21)00030-2.

    PubMed 33894193

Questions about this trial

What is this clinical trial studying?

An observational study of PARKINSON DISEASE (Disorder) and Atypical Parkinsonism, run by International Institute of Molecular and Cell Biology in Warsaw at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differential expression of selected microRNAs (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07604883, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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