Validation of α-synuclein biomarkers for Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The VαMPiRE project aims to validate specific α-synuclein isoforms and their modifications as biomarkers for early detection and monitoring of Parkinson's disease (PD). This multicenter, longitudinal observational study utilizes innovative biochemical analyses and AI-driven data models to develop a cost-effective, non-invasive diagnostic method. By focusing on the accumulation of misfolded α-synuclein proteins, the study seeks to address the urgent need for reliable early detection tools in PD, which currently rely on subjective assessments and expensive imaging techniques.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • For PD subjects

  * PD diagnosis according to MDS-UPDRS criteria and Hoehn and Yahr scale between I-IV (MED ON) for PD subjects
  * Willing to participate. Participation is always voluntary.
  * Willing and able to provide written informed consent to participate in the study or having a legal representative responsible for signing; the participant (or the legal representative) must understand the purpose, methods, and all information regarding the study.
  * For non-PD subjects
  * Normal neurological examination findings.
  * Medical record (recent and remote medical history) available and reviewable by clinicians during the entire study period.
  * Willing and able to provide written informed consent to participate in the study

Exclusion Criteria:

* • For PD and non-PD subjects

  * Clinically significant and severe cognitive decline and/or intellectual disability which can lead to impairment not caused by Parkinson's disease or any other disease that could better explain the patient's symptoms; The exclusion criteria involve neurological and neurodevelopmental disorders including disorders of the brain, spinal cord, peripheral nerve, and muscle (e.g. cerebral palsy, epilepsy \[seizure disorders\], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury).
  * Fever (Temperature 38.0 °C (tympanic)).
  * Acute infection (such as Flu, COVID-19) which could debilitate the patient and affect the data.
  * Individuals with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations (e.g. HepC, HIV, TB).
  * Life-threatening co-existing disease with life expectancy, which could lead to premature dropout.
  * Any other neurological or systemic conditions that could confound results.

Where it's running

• Aristotle University of Thessaloniki
  Thessaloniki, Greece Recruiting
• Casa di Cura Igea
  Milan, Mi, Italy Recruiting
• Instytut Psychiatrii I Neurologii
  Warsaw, Poland Recruiting
• Asociacion Parkinson Madrid
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Elda Judica, MD — Casa di Cura IGEA
• Study coordinator: Elda Judica, MD
• Email: e.judica@casadicuraigea.it
• Phone: +39 0248593242

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.