Blood test tracks Parkinson progression

Trial ID
NCT06941012
Official Title
Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution (VaMPiRE)
Goal
Blood test tracks Parkinson progression
Status
RECRUITING
Sponsor
Casa di Cura IGEA
Study Type
OBSERVATIONAL
Enrollment
1200 participants
Conditions
Parkinson Disease (PD)
Interventions
Blood draw for the laboratory assessment

Summary For Families

VaMPiRE aims to find whether specific chemical modifications of the α-synuclein protein in blood track Parkinson's progression or can help tell people with PD apart from those without. The team will collect blood samples to measure modified forms of α-synuclein, the protein that misfolds and clumps in Parkinson's, looking for patterns linked to symptom severity or disease stage; this is observational only and does not change medications or interact with levodopa. Adults 18 to 85 are eligible, including people with PD diagnosed by MDS-UPDRS and Hoehn and Yahr stages I,IV while on meds, plus neurologically normal controls, with exclusions for severe cognitive decline, active infections, other confounding neurological conditions, or life‑threatening illnesses.

Locations

  • Aristotle University of Thessaloniki, Thessaloniki, Greece
  • Casa di Cura Igea, Milan, Mi, Italy
  • Instytut Psychiatrii I Neurologii, Warsaw, Poland
  • Asociacion Parkinson Madrid, Madrid, Spain

Frequently Asked Questions

What is this trial testing?
This trial is studying Blood draw for the laboratory assessment. VaMPiRE aims to find whether specific chemical modifications of the α-synuclein protein in blood track Parkinson's progression or can help tell people with PD apart from those without. The team will collect blood samples to measure modified forms of α-synuclein, the protein that misfolds and clumps in Parkinson's, looking for patterns linked to symptom severity or disease stage; this is observational only and does not change medications or interact with levodopa. Adults 18 to 85 are eligible, including people with PD diagnosed by MDS-UPDRS and Hoehn and Yahr stages I,IV while on meds, plus neurologically normal controls, with exclusions for severe cognitive decline, active infections, other confounding neurological conditions, or life‑threatening illnesses.
Who can participate?
Participants must be between 18 Years and 85 Years.
Where is this trial located?
This trial is recruiting at 4 locations.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 3 years and 7 months.
Will I get the real drug or a placebo?
It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
How often will I need to visit the study site?
Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
Can I leave the trial if I change my mind?
Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
Will travel or parking be reimbursed?
Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
Can my spouse or care partner come with me to visits?
In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.

Related Reading

View on ClinicalTrials.gov