Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes (BIOMARK-PS)
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.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Jacek Kuźnicki, Professor
- Telefonnummer: +48 22 5970700
- E-Mail: jacek.kuznicki@iimcb.gov.pl
Studienorte
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Warsaw, Polen, 03-242
- Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw
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Kontakt:
- Dariusz Koziorowski, Professor
- E-Mail: dariusz.koziorowski@wum.edu.pl
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Warsaw, Polen, 00-416
- Department of Neurology, CMKP Prof. Witold Orłowski Clinical Hospital, Warsaw
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Kontakt:
- Urszula Fiszer, Professor
- E-Mail: ufiszer@cmkp.edu.pl
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Differential expression of selected microRNAs
Zeitfenster: 18 months
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Identification of microRNA in peripheral blood enabling the differentiation of PD and APS at an early stage of the disease.
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18 months
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Differences in metabolomic profiles
Zeitfenster: 18 months
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Identification of metabolomic profiles in peripheral blood enabling the early differentiation between PD and APS.
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18 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Ability of biomarkers to differentiate PD and APS
Zeitfenster: 18 months
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Assessing the diagnostic accuracy of biomarkers in differentiating PD from APS-analysis of receiver operating characteristic curves.
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18 months
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Changes in molecular (miRNA, metabolomic) profiles over time
Zeitfenster: 18 months
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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).
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18 months
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Identification of clinical predictors of atypical parkinsonian syndrome development.
Zeitfenster: 18 months
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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
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Jacek Kuźnicki, The International Institute of Molecular and Cell Biology in Warsaw
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Synucleinopathien
- Neurologische Manifestationen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Psychische Störungen
- Neurokognitive Störungen
- Augenkrankheiten
- Demenz
- Tauopathien
- Neurodegenerative Krankheiten
- Bewegungsstörungen
- Parkinsonsche Störungen
- Erkrankungen der Basalganglien
- Erkrankungen der Hirnnerven
- Primäre Dysautonomien
- Erkrankungen des autonomen Nervensystems
- Ophthalmoplegie
- Augenmotilitätsstörungen
- Lähmung
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Parkinson Krankheit
- Multiple Systematrophie
- Supranukleäre Lähmung, progressiv
- Lewy-Körper-Krankheit
Andere Studien-ID-Nummern
- KB/40/2026 (Andere Kennung: Medical University of Warsaw Bioethical Comittee)
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