Brain Microglial Activation in the Early Stage of the Parkinson's Disease: a Predictive Biomarker of the Evolution?

RC17_0012

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).

2018-04-16

2024-05-06

2024-05-06

Active (not recruiting)

Early phase I

31

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}

2024-04-25