Identification of a Biomarker Predictive of Evolution of Parkinson Disease

• Status: Recruiting
• Trial end date: 2024-10-16
• Target enrollment: 0
• Participant gender: All

Summary

Phase II, Open-labeled, Prospective, Multi-center study of assessing the link between microglial activation and dopaminergic denervation kinetics in the early stage of Parkinson disease, by using the imaging of [18F]DPA-714 a new ligand of Translocator Protein-18 kDa (TSPO) by Positron Emission Tomography (PET).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital

Criteria

Inclusion Criteria:

• Patients having a Parkinson's disease diagnosed according to the criteria UKPDSBB.

• Diagnosis done less than three years before the date the inclusion.

• Patient Age at diagnosis : between 40 and 65 years.

• Absence of clinical arguments for an associated neurovascular pathology.

• Written consent obtained.

• HAB polymorphism in the genotyping of TSPO gene.

• Brain MRI without following abnormalities: cortical or sub-cortical atrophy or hippocampal atrophy (Scheltens score ≥2), vascular encephalopathy (Fazekas score > 2, > 10 microbleed) or showing signs in favour of atypical parkinson syndrome.

Exclusion Criteria:

• Pregnant woman

• Minor

• Adult protected by the law

• Contraindication to PET-scan

• Contraindication to brain MRI

• History of inflammatory or dysimmune chronic disease

• History of psychiatric disease or drug addiction

• History of cognitive disorders (MMS<26)

• Hypersensibility to iodine derivates or one of these components

• Long-term Treatments which can interfere in neuroinflammation process

• Treatments / substances susceptible to interfere with the 18F-DPA-714

• TSPO gene Polymorphisms rs6971 corresponding to groups of affinity of low affinity (LAB=Low Affinity Binder) or moderated MAB = Mixed Affinity Binder)

• Modification of diagnosis of Parkinson disease during follow-up, in particular towards an atypical parkinson-like syndrome