Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes

NCT07604883 | Not Yet Recruiting

• 1 other identifier: KB/40/2026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

This prospective observational study aims to identify and preliminarily validate molecular biomarkers, including microRNAs and metabolites, for early differentiation between Parkinson's disease (PD) and atypical parkinsonian syndromes (APS). The study will enroll up to 100 PD patients, 50 suspected APS patients, and 50 healthy controls. Participants will undergo clinical assessments and provide blood, urine, and stool samples at baseline and after 12-18 months. Molecular analyses (microRNA profiling, metabolomics, RNA-seq, and microbiome analysis) will be performed to identify diagnostic signatures. The primary goal is to detect differences in molecular profiles, while secondary objectives include evaluating the diagnostic accuracy of biomarker panels and their changes over time. Although participants will not receive direct therapeutic benefits, the study may contribute to the development of non-invasive tools for early diagnosis and improved differentiation of parkinsonian disorders

Conditions

PARKINSON DISEASE (Disorder); Atypical Parkinsonism; Multiple System Atrophy; Progressive Supranuclear Palsy (PSP); Dementia With Lewy Bodies (DLB)

Keywords

parkinson disease; atypical parkinsonism; progressive supranuclear palsy; multiple system atrophy; dementia with lewy bodies; biomarker

Outcome Measures

Primary Outcomes (2)

• Differences in the expression of selected microRNAs

  Identification of microRNA in peripheral blood enabling the differentiation of Parkinson's disease and atypical parkinsonian syndromes at an early stage of the disease.

  18 months

• Differences in metabolomic profiles

  Identification of metabolomic profiles in peripheral blood enabling the differentiation of Parkinson's disease and atypical parkinsonian syndromes at an early stage of the disease

  18 months

Secondary Outcomes (2)

• Ability of biomarkers to differentiate Parkinson's disease and atypical parkinsonian syndromes (ROC analyses)

  18 months

• Changes in molecular (miRNA, metabolomic etc) profiles over time

  18 months

Other Outcomes (1)

• Identification of clinical predictors of atypical parkinsonian syndrome development.

  18 months

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with suspected neurodegenerative parkinsonism associated with Parkinson's disease (PD) or atypical parkinsonian syndromes (APS), diagnosed according to the Movement Disorder Society (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. Additional exclusion criteria include

You may qualify if:

• Patients with suspected neurodegenerative parkinsonism in the course of Parkinson's disease (PD) or atypical parkinsonian syndromes (APS), defined according to the MDS 2015 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 DaTscan result confirming presynaptic dopaminergic neuronal degeneration.

You may not qualify if:

• 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 (advanced heart failure NYHA class III-IV, poorly controlled diabetes mellitus, renal failure with GFR ≤ 60, or hepatic failure).
• Presence of a known monogenic mutation causing parkinsonism according to OMIM classification.
• Antibiotic therapy or use of probiotics within 3 months prior to the study visit.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• International Institute of Molecular and Cell Biology in Warsaw: lead
• Medical University of Warsaw: collaborator
• Medical Centre for Postgraduate Education: collaborator

Study Sites (2)

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

Warsaw, 00-416, Poland

Location

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

Warsaw, 03-242, Poland

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood samples for miRNA, DNA

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Supranuclear Palsy, Progressive; Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jacek Kuźnicki

  The International Institute of Molecular and Cell Biology in Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacek Kuźnicki, Professor

CONTACT

+48 22 5970700; jacek.kuznicki@iimcb.gov.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 4, 2026
• Primary Completion (Estimated): January 4, 2029
• Study Completion (Estimated): June 4, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

PL (2)