The VαMPiRE project

The challenge

α-Synuclein isoforms.
The potential for Parkinson’s disease detection

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 progression remains unclear, complicating early diagnosis and treatment. Recent advances in PD pathophysiology suggest promising treatments to slow disease progression, yet reversing cellular degeneration remains elusive. With novel therapies emerging, the need for early detection tools is urgent. However, validated biomarkers for PD diagnosis are lacking, relying on subjective scales like Hoehn and Yahr or costly medical imaging techniques. The accumulation of misfolded α-Synuclein (α-Syn) proteins in PD pathology has sparked interest, but defining diagnostic roles requires further investigation. Recent findings of α-Syn in neuronal-derived extracellular vesicles (NDEVs) from PD patients suggest a potential for novel diagnostic methods. Our proposed project, VαMPiRE, aims to conduct a longitudinal study involving 600 PD and 600 non-PD participants using a cluster-adjusted case-control methodology, to explore α-Syn isoforms and related biomarkers in NDEVs for early PD detection.

We plan to develop and validate an innovative in-vitro diagnostic (IVD) test capable of detecting PD’s earliest stages and estimating disease prognosis and progression. Utilizing AI models to generate data analysis algorithms and collaboration with leading analytical laboratories and IVD manufacturers, we aim to ensure the reliability and feasibility of the developed prototype. Through consortium efforts, we envision licensing the generated intellectual property to drive the commercialization of our results. 
Two round of blood sample extractions will be performed within a 24-month gap to PD participants and a single baseline for non-PD controls. All participants will be regularly followed up during this 24-month period to monitor disease evolution and treatment, and non-PD controls developing the disease will be part of a third cohort (expected to be around24 subjects according to 4% incidence) that will confirm the sensitivity of the test in asymptomatic subjects. The unique aspect of the project is that we anticipate being able to detect theses 4% of non-PD participants that will go on to develop the disease, therefore demonstrating the value of these biomarkers to identify PD early.

The PLAN

Developing a Cutting-Edge IVD Test for Early Parkinson’s Detection and Prognosis

The RESULT

Validating a Breakthrough IVD Test to Transform Parkinson’s Detection and Management


The prototype will be validated for its discriminative capacity, using the first baseline set of PD and non-PD samples, and for its ability to detect the PD-progression comparing baseline and 24-months data plus blood samples.
Improved early screening could allow for 270,000 new cases of PD to be detected earlier, improve the disease management of 9.4 M people currently diagnosed of PD and avoid losing a total of 5.8 million disability adjusted life years (DALYs) by 2028 leading also the development of better treatments.

A Groundbreaking Initiative for Early Diagnosis and Improved Management of Parkinson’s Disease

Parkinson’s disease (PD) represents a significant challenge due to its progressive neurodegenerative nature, impacting multiple body systems and affecting over 1.2 million Europeans. Despite decades of research, our understanding of the disease’s onset and progression remains limited, hindering early diagnosis and effective treatment.
Recent advances in PD physiopathology offer hope for slowing disease progression; however, reversing cellular degeneration remains out of reach. This underscores the urgent need for innovative diagnostic tools to detect PD at its earliest stages. Currently, diagnosis relies on subjective scales, such as Hoehn and Yahr, or expensive imaging technologies, with no validated biomarkers available for widespread clinical use
VαMPiRE seeks to revolutionize PD diagnostics through a longitudinal matched case-control study involving 600 PD patients and 600 non-PD participants. By investigating α-Syn isoforms and related biomarkers in NDEVs, our project aims to develop and validate an in vitro diagnostic (IVD) test capable of:

  • Detecting PD at its earliest stages, when interventions can be most impactful.
  • Estimating disease prognosis and monitoring progression.
  • Guiding treatment strategies based on individualized disease profiles.

Exploring the Potential of α-Synuclein and NDEVs

The accumulation of misfolded α-synuclein (α-Syn) proteins is a hallmark of PD pathology and a promising avenue for diagnostic innovation. Recent findings have identified α-Syn in neuronal-derived extracellular vesicles (NDEVs) from PD patients, highlighting its potential for novel diagnostic methods

Innovative Approach

To ensure the reliability and feasibility of the IVD prototype:

  • AI-driven algorithms will analyze biomarker data, ensuring precision and scalability.
  • Partnerships with leading analytical laboratories and IVD manufacturers will support robust test development.
  • The consortium will pursue intellectual property licensing to drive commercialisation and accessibility.

Study Design and Validation

  • Two blood samples will be collected from PD participants over 24 months, alongside baseline samples from non-PD controls.
  • Monthly follow-ups will track disease progression, and any non-PD controls developing PD (approximately 4%, or 24 participants) will join a third cohort to validate test sensitivity in symptom-free individuals.
  • The prototype will undergo rigorous validation, comparing detection capabilities at baseline and after 24 months to predict disease evolution and treatment response.

Transformational Impact

By 2028, VαMPiRE has the potential to:

  • Enable early detection of 270,000 new PD cases annually.
  • Improve disease management for the 9.4 million people currently living with PD worldwide.
  • Prevent the loss of 5.8 million disability-adjusted life years (DALYs).
  • Lay the groundwork for developing and implementing better treatments

This project has received funding from the European Union’s HORIZON-HLTH-2024-DISEASE-03-two-stage program under grant agreement No 101156370.
Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HORIZON-RIA. Neither the European Union nor the granting authority can be held responsible for them.

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