NCT03230526

Identification of a Biomarker Predictive of Evolution of Parkinson Disease

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 67 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The Parkinson's disease ( MP) is a frequent but heterogeneous neurodegenerative disease in term of clinical presentation(display) and evolutionary profile. The therapeutic coverage(care) of the patients would thus be personalized Such an approach remains still in its infancy in 2017. Better know the factors which determine the evolutionary clinical subcategories is a major question of the current researches on the Parkinson disease. Nigrostriaial inflammation is an interesting candidate. Microglia activation is closely associated with the degenerative process. Development of the molecular imaging allows to study nigrostriatal inflammation in vivo in human by positron emission tomography (PET) by using the radiotracer of the protein of translocation of 18KDa ( TSPO), considered as a marker of microglia activation Some studies showed an increase of the inflammation in the striatum and in the substantia nigra, the sites of the dopaminergic degeneration (The lesional core of the Parkinson disease is the damage of the dopaminergic nigrostriatale way). However data remain rare and concern small number of patients. Some data are inconsistent because of problems of specificity of the ligands used and variation between populations of studied patients (duration of disease evolution). In this study, investigators suggest studying by imaging TEP using a ligand new of the TSPO, \[18F\]DPA-714, microglial brain activation in the early stage of the Parkinson disease and determine wether it is predictive of speed of disease progression.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	[18F]DPA-714 PET scan	One PET scan using \[18F\]DPA-714 is done at M2 between two \[123I\]FP-CIT scan (DaTscan) done at M1 and M23. Neuropsychological assessment is done at M0, M18 and M24

Timeline

• Start date: 2018-04-16
• Primary completion: 2024-05-06
• Completion: 2024-05-06
• First posted: 2017-07-26
• Last updated: 2024-04-25

Locations

4 sites across 1 country: France