Status:
RECRUITING
Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution
Lead Sponsor:
Casa di Cura IGEA
Collaborating Sponsors:
Asociación Parkinson Madrid
Aristotle University Of Thessaloniki
Conditions:
Parkinson Disease (PD)
Eligibility:
All Genders
18-85 years
Brief Summary
Parkinson's disease (PD) presents a complex challenge due to its progressive neurodegenerative nature, affecting various bodily systems. Despite decades of research, understanding its onset and progre...
Detailed Description
The VαMPiRE study (Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution) is a multicenter, longitudinal observational study in the context of European Grant Horizon Europe (101156...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
May 12 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06941012
Start Date
May 12 2025
End Date
April 30 2029
Last Update
May 29 2025
Active Locations (4)
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1
Aristotle University of Thessaloniki
Thessaloniki, Greece, 54124
2
Casa di Cura Igea
Milan, Mi, Italy, 20144
3
Instytut Psychiatrii I Neurologii
Warsaw, Poland, 02-957
4
Asociacion Parkinson Madrid
Madrid, Spain, 28014