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

25. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

International Institute of Molecular and Cell Biology in Warsaw

Samarbeidspartnere

Medical University of Warsaw
Medical Centre for Postgraduate Education

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

4. juni 2026

Primær fullføring (Antatt)

4. januar 2029

Studiet fullført (Antatt)

4. juni 2029

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

OSF, anonymised laboratory and clinical data of participants

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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