What is this study trying to find out about Parkinson's disease?

This study is investigating specific forms of the protein alpha-synuclein in blood samples to help detect Parkinson's disease early and monitor its progression. Researchers aim to develop a non-invasive, cost-effective diagnostic test using AI and clinical assessments. The study is sponsored by Casa di Cura IGEA and involves multiple centers across Europe.

Who may be eligible for this Parkinson's disease clinical trial?

Adults aged 18 to 85 years diagnosed with Parkinson's disease or healthy individuals with normal neurological exams may be eligible. Participants must be willing and able to provide informed consent. Individuals with severe cognitive decline unrelated to Parkinson's or certain infections are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this Parkinson's disease clinical trial?

Study-related care, including blood draws and clinical assessments, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs incurred.

Actively Recruiting

Age: 18Years - 85Years

All Genders

Healthy Volunteers

ID06941012

Validation of -synuclein Modifications in Parkinsons dIsoRder Evolution VaMPiRE

Led by Casa di Cura IGEA · Updated on 2026-03-02

1200

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Parkinsons disease PD is a progressive neurodegenerative disorder affecting multiple body systems, and its exact cause and progression remain unclear, making early diagnosis and treatment difficult. Researchers are investigating the role of specific forms of the protein alpha-synuclein in PD, aiming to develop better diagnostic tools. This study, called VMPiRE, plans a large observational approach involving 600 PD patients and 600 people without PD to explore these protein forms as early markers of the disease. The study will collect blood samples from participants at the start and again 24 months later for PD patients, while non-PD participants will have a baseline sample only. Various clinical assessments will be performed, including neurological, balance, cognitive, depression, and quality of life tests, tailored to each group. The goal is to develop and validate a blood test that can detect early PD and monitor its progression, using AI-driven data analysis and collaboration with specialized laboratories. Participants will be regularly followed over 24 months to monitor disease evolution and treatment. Assessments include clinical history reviews, neurological exams, and several standardized rating scales. The primary outcome is measuring alpha-synuclein forms in neuronal-derived extracellular vesicles from blood at baseline and after 24 months. Secondary outcomes include validating AI-based predictive scores for PD diagnosis. The study aims to improve early detection and disease management, potentially benefiting millions worldwide.

CONDITIONS

Brief Title

Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution

Who Can Participate

Age: 18Years - 85Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

For PD subjects: Diagnosis of Parkinson's disease according to MDS-UPDRS criteria and Hoehn and Yahr scale between I-IV (MED ON)
Willing to participate voluntarily
Able and willing to provide written informed consent or have a legal representative do so
For non-PD subjects: Normal neurological examination findings
Medical records available for review during the study
Able and willing to provide written informed consent

You will not qualify if you...

Severe cognitive decline or intellectual disability not caused by Parkinson's or other diseases
Neurological or neurodevelopmental disorders such as cerebral palsy, epilepsy, stroke, muscular dystrophy, or spinal cord injury
Fever with temperature 38.0 °C (tympanic)
Acute infections like Flu or COVID-19 affecting health
Active infections requiring systemic antimicrobial or antiviral therapy, e.g. Hepatitis C, HIV, tuberculosis
Life-threatening diseases with limited life expectancy
Other neurological or systemic conditions that could affect study results

Research Team

Elda Judica, MD

Annunziata Tramontano

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