Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: PARKINSON DISEASE (Disorder), Atypical Parkinsonism, Multiple System Atrophy, Progressive Supranuclear Palsy (PSP). Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Primary outcome measures
- Differential expression of selected microRNAs [Time frame: 18 months]
- Differences in metabolomic profiles [Time frame: 18 months]
Secondary outcome measures (2)
- Ability of biomarkers to differentiate PD and APS [Time frame: 18 months]
- Changes in molecular (miRNA, metabolomic) profiles over time [Time frame: 18 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Poland · 2 centers
- Department of Neurology, CMKP Prof. Witold Orłowski Clinical Hospital, Warsaw — Warsaw
- Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw — Warsaw
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33894193
Identifiers
NCT: NCT07604883 · KB/40/2026 · KB/40/2026