Parkinson Disease (PD)VaMPiRENCT06941012
Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution
An observational study of Parkinson Disease (PD), run by Casa di Cura IGEA at 4 sites in 4 countries.
Trial 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 progression remains unclear, complicating early diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Blood draw for the laboratory assessment
- How many people
- 1,200 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 12 May 2025to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment will be conducted across five clinical sites, with each site contributing based on its recruitment capacity and resources. PD patients and non-PD controls will be recruited among similar characteristics. A matched case-control approach will be implemented to meet the study's objectives. Matching will be used to control for potential confounding factors. By pairing or grouping participants with PD (cases) and those without PD (non-PD controls) based on shared characteristics-such as age, gender, geographic location, and relevant comorbidities (e.g., type 2 diabetes, hypertension, anemia, gastrointestinal dysfunction, etc.)-we aim to reduce bias and enhance statistical efficiency in adjusted analysis. As it will be difficult to exactly match all cases with equivalent controls, we will use the stratification to cluster PD and non-PD participants so comparative analysis can be performed between PD and non-PD equivalent clusters. Each time a participant is recruited into PD, he/
Who may be able to join
- • 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
Who cannot join
- • 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.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Greece1 site, 1 recruiting
- Recruiting
Aristotle University of Thessaloniki
Thessaloniki, 54124
Savvas Petanidis, 0030 2310999205, spetanid@auth.gr
Italy1 site, 1 recruiting
- Recruiting
Casa di Cura Igea
Milan, Mi, 20144
Elda Judica, MD, 0039 02 48593242, e.judica@casadicuraigea.it
Poland1 site, 1 recruiting
- Recruiting
Instytut Psychiatrii I Neurologii
Warsaw, 02-957
Tomasz Stępień, 0048 22458 25 00, tstepien@ipin.edu.pl
Spain1 site, 1 recruiting
- Recruiting
Asociacion Parkinson Madrid
Madrid, 28014
Mayca Marin Valero, 0034 914 340406, investigacion@parkinsonmadrid.org
About this study
Official title: Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution (VaMPiRE)
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.
Read more
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 around 24 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 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.
Read the 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 (101156370-2) and is designed to validate specific α-synuclein (α-Syn) isoforms and their post-translational modifications as biomarkers for the early detection and progression monitoring of Parkinson's disease (PD). The study addresses the critical unmet need for a cost-effective, non-invasive diagnostic method by combining innovative biochemical analyses, artificial intelligence (AI)-driven data models, and comprehensive clinical assessments. This effort aligns with emerging global priorities to enhance the early diagnosis and personalized treatment of neurodegenerative diseases.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Blood draw for the laboratory assessment
- Keywords
- α-Synuclein
- Medical subject headings
- Parkinson Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for the laboratory assessmentOther
Also called Neurologic evaluation
Participants' clinical histories will be reviewed at T0 (baseline) and T1 (24 months). They will also undergo a clinical assessment at T0 and T1. The assessments will be tailored based on whether the participant belongs to the PD or non-PD group, as outlined below: • MDS-UPDRS + H\&Y: Used to evaluate the neurological domain, applied to the PD group. • BERG: Used to assess balance and performance, applied to both PD and non-PD groups. • CIRS-G: Used to evaluate comorbidities, applied to both PD and non-PD groups. • PD-CRS: Used to assess cognitive function, applied to the PD group. • MMSE (temporal and spatial orientation only): Used to assess cognitive function, applied to both PD and non-PD groups. • PDQ-8: Used to evaluate quality of life, applied to the PD group. • PD-CFRS: Used for functional assessment, applied to the PD group. • GDS: Used to assess depression, applied to both PD and non-PD groups. Blood samples will be collected at T0 and T1, with 20 mL drawn per participant.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson (PD) | Not described Receives: Other: Blood draw for the laboratory assessment | |
| Non-PD controls | Not described Receives: Other: Blood draw for the laboratory assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of α-Synuclein Isoforms (-140, -126, -112, -98) and Their SUMOylated Forms in NDEVs from Blood Samples
The primary outcome measure involves the quantification of α-synuclein (α-Syn) isoforms (-140, -126, -112, -98) and their SUMOylated forms in neuronal-derived extracellular vesicles (NDEVs) isolated from blood samples. Advanced biochemical techniques, including lateral flow immunoassay coupled with digital readers, are employed for precise quantification. AI-driven data analysis evaluates correlations between biomarker levels and Parkinson's Disease (PD) progression.
Clinical Implications:
This outcome aims to validate α-Syn biomarkers for early PD diagnosis, offering a non-invasive, cost-effective alternative to current methods like DaT imaging. Reliable identification of α-Syn isoforms could improve early intervention strategies, slow disease progression, and support personalized treatment plans. Additionally, it could provide insights into disease mechanisms, enhancing future therapeutic developments and enabling scalable, accessible diagnostic solutions globally.
Measured: Baseline (T0) and 24 months post-enrollment (T1).
Secondary outcomes (1)
Validation of AI-Generated predictive score for PD diagnosis
Development and validation of artificial intelligence (AI)-powered diagnostic algorithms utilizing multivariate biomarker data, clinical assessments, and demographic variables. The AI model generates a predictive score correlating α-Syn biomarker levels with disease onset, progression, and treatment response. The validation process evaluates the model's sensitivity, specificity, and predictive accuracy for Parkinson's Disease diagnosis.
Measured: Baseline (T0), every 3 months through periodic surveys, and 24 months post-enrollment (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start12 May 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura IGEA
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Parkinson Madrid, Aristotle University Of Thessaloniki, Institute of Psychiatry and Neurology, Warsaw, LINKCARE HEALTH SERVICES SL, ALMAWAVE SPA, European Brain Research Foundation
- Responsible party
- Sponsor
- Investigators
- Marco Feligioni, PHD, Study chair, EBRI-European Brain Research InsituteElda Judica, MD, Principal investigator, Casa di Cura IGEA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941012
- Sponsor's protocol ID
- 101156370
- Acronym
- VaMPiRE
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes, demographic and baseline characteristics will be made available to qualified researchers upon reasonable request, following publication of study results. Data will be shared through appropriate data repositories and in compliance with applicable ethical and legal regulations. Via submission of a data access request to the study sponsor. Data will be shared through a secure institutional repository (e.g., Zenodo, ORE, EOSC).Key Exploitable Results will be disseminated through the Horizon Results Platform.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution (VaMPiRE)
- ClinicalTrials.gov ID
- NCT06941012
- Acronym / sponsor ID
- VaMPiRE / 101156370
- Conditions
- Parkinson Disease (PD)
- Keywords
- α-Synuclein
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Casa di Cura IGEAUniversity, hospital or other
- Collaborators
- Asociación Parkinson Madrid, Aristotle University Of Thessaloniki, Institute of Psychiatry and Neurology, Warsaw, LINKCARE HEALTH SERVICES SL, ALMAWAVE SPA, European Brain Research Foundation
- Study start
- 12 May 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 around 24 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 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.
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 (101156370-2) and is designed to validate specific α-synuclein (α-Syn) isoforms and their post-translational modifications as biomarkers for the early detection and progression monitoring of Parkinson's disease (PD). The study addresses the critical unmet need for a cost-effective, non-invasive diagnostic method by combining innovative biochemical analyses, artificial intelligence (AI)-driven data models, and comprehensive clinical assessments. This effort aligns with emerging global priorities to enhance the early diagnosis and personalized treatment of neurodegenerative diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson (PD) | – | Other: Blood draw for the laboratory assessment |
| Non-PD controls | – | Other: Blood draw for the laboratory assessment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be conducted across five clinical sites, with each site contributing based on its recruitment capacity and resources. PD patients and non-PD controls will be recruited among similar characteristics. A matched case-control approach will be implemented to meet the study's objectives. Matching will be used to control for potential confounding factors. By pairing or grouping participants with PD (cases) and those without PD (non-PD controls) based on shared characteristics-such as age, gender, geographic location, and relevant comorbidities (e.g., type 2 diabetes, hypertension, anemia, gastrointestinal dysfunction, etc.)-we aim to reduce bias and enhance statistical efficiency in adjusted analysis. As it will be difficult to exactly match all cases with equivalent controls, we will use the stratification to cluster PD and non-PD participants so comparative analysis can be performed between PD and non-PD equivalent clusters. Each time a participant is recruited into PD, he/
Key inclusion criteria (8 listed)
- • For PD subjects
Key exclusion criteria (7 listed)
- • For PD and non-PD subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw for the laboratory assessmentAlso: Neurologic evaluationParticipants' clinical histories will be reviewed at T0 (baseline) and T1 (24 months). They will also undergo a clinical assessment at T0 and T1. The assessments will be tailored based on whether the participant belongs to the PD or non-PD group, as outlined below: • MDS-UPDRS + H\&Y: Used to evaluate the neurological domain, applied to the PD group. • BERG: Used to assess balance and performance, applied to both PD and non-PD groups. • CIRS-G: Used to evaluate comorbidities, applied to both PD and non-PD groups. • PD-CRS: Used to assess cognitive function, applied to the PD group. • MMSE (temporal and spatial orientation only): Used to assess cognitive function, applied to both PD and non-PD groups. • PDQ-8: Used to evaluate quality of life, applied to the PD group. • PD-CFRS: Used for functional assessment, applied to the PD group. • GDS: Used to assess depression, applied to both PD and non-PD groups. Blood samples will be collected at T0 and T1, with 20 mL drawn per participant. | Other | Non-PD controls, Parkinson (PD) |
Primary outcome
Quantification of α-Synuclein Isoforms (-140, -126, -112, -98) and Their SUMOylated Forms in NDEVs from Blood Samples
Time frame: Baseline (T0) and 24 months post-enrollment (T1).
The primary outcome measure involves the quantification of α-synuclein (α-Syn) isoforms (-140, -126, -112, -98) and their SUMOylated forms in neuronal-derived extracellular vesicles (NDEVs) isolated from blood samples. Advanced biochemical techniques, including lateral flow immunoassay coupled with digital readers, are employed for precise quantification. AI-driven data analysis evaluates correlations between biomarker levels and Parkinson's Disease (PD) progression. Clinical Implications: This outcome aims to validate α-Syn biomarkers for early PD diagnosis, offering a non-invasive, cost-effective alternative to current methods like DaT imaging. Reliable identification of α-Syn isoforms could improve early intervention strategies, slow disease progression, and support personalized treatment plans. Additionally, it could provide insights into disease mechanisms, enhancing future therapeutic developments and enabling scalable, accessible diagnostic solutions globally.
1 secondary outcome
Validation of AI-Generated predictive score for PD diagnosis
Time frame: Baseline (T0), every 3 months through periodic surveys, and 24 months post-enrollment (T1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcomes, demographic and baseline characteristics will be made available to qualified researchers upon reasonable request, following publication of study results. Data will be shared through appropriate data repositories and in compliance with applicable ethical and legal regulations. Via submission of a data access request to the study sponsor. Data will be shared through a secure institutional repository (e.g., Zenodo, ORE, EOSC).Key Exploitable Results will be disseminated through the Horizon Results Platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Feligioni, PHD study chair
EBRI-European Brain Research Insitute
Elda Judica, MD principal investigator
Casa di Cura IGEA
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease (PD), run by Casa di Cura IGEA at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece, Italy, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elda Judica, MD (+39 0248593242, e.judica@casadicuraigea.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of α-Synuclein Isoforms (-140, -126, -112, -98) and Their SUMOylated Forms in NDEVs from Blood Samples (time frame: Baseline (T0) and 24 months post-enrollment (T1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.