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

25. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differential expression of selected microRNAs
Tidsramme: 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
Tidsramme: 18 months
Identification of metabolomic profiles in peripheral blood enabling the early differentiation between PD and APS.
18 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ability of biomarkers to differentiate PD and APS
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Identification of clinical predictors of atypical parkinsonian syndrome development.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

International Institute of Molecular and Cell Biology in Warsaw

Samarbejdspartnere

Medical University of Warsaw
Medical Centre for Postgraduate Education

Efterforskere

  • Ledende efterforsker: Jacek Kuźnicki, The International Institute of Molecular and Cell Biology in Warsaw

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

4. juni 2026

Primær færdiggørelse (Anslået)

4. januar 2029

Studieafslutning (Anslået)

4. juni 2029

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KB/40/2026 (Anden identifikator: Medical University of Warsaw Bioethical Comittee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

OSF, anonymised laboratory and clinical data of participants

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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