Validation of α-synuclein biomarkers for Parkinson's disease
Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution (VaMPiRE)
This study is testing new ways to detect Parkinson's disease early by looking for specific proteins in the body, which could help patients get diagnosed more easily and quickly.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Casa di Cura IGEA Academic / other |
| Locations | 4 sites (Thessaloniki and 3 other locations) |
| Trial ID | NCT06941012 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Parkinson's disease according to MDS-UPDRS criteria and those with normal neurological examination findings.
Not a fit: Patients with clinically significant cognitive decline or intellectual disabilities unrelated to Parkinson's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and personalized treatment options for patients with Parkinson's disease.
How similar studies have performed: Other studies have shown promise in using biomarkers for neurodegenerative diseases, but the specific approach of validating α-synuclein modifications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Thessaloniki and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.