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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
31
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
CHU de Nantes
Nantes, France
Centre Eugène Marquis
Rennes, France
CHU de Rennes
Rennes, France
CHU de Tours
Tours, France
Coefficient of correlation between level of microglial striatal activation and the And the dopaminergic denervation kinetics
Coefficient of correlation between the striatal microglial activation level measured by PET imaging \[binding potential (BP) of 18F-DPA-714 in the striatum\] and dopaminergic denervation kinetics obtained from two 123I-FP-CIT (DaTscan) scans
Time frame: 24 months
Analyze the relationship between the level of microglial activation in the black substance at the early stage of MP and the dopaminergic denervation kinetics
Will be estimated by imaging PET with \[18F\]DPA-714
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)
The equivalent dose of cumulative L-Dopa
Time frame: baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)
The equivalent dose of cumulative L-Dopa
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)
The equivalent dose of cumulative L-Dopa
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)
MDS-UPDRS scale (part III "OFF" - Part III "ON" and part II)
Time frame: Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)
MDS-UPDRS scale (part III "OFF" - Part III "ON" and part II)
Time frame: 18 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)
MDS-UPDRS scale (part III "OFF" - Part III "ON" and part II)
Time frame: 24 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)
MDS-UPDRS scale (part IV)
Time frame: baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)
MDS-UPDRS scale (part IV)
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)
MDS-UPDRS scale (part IV)
Time frame: 24 months
Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)
QUIP RS
Time frame: baseline
Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)
QUIP RS
Time frame: 18 months
Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)
QUIP RS
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)
MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)
Time frame: baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)
MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)
MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)
MDS-UPDRS scale (part II : 2.13 and part III : 3.11)
Time frame: baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)
MDS-UPDRS scale (part II : 2.13 and part III : 3.11)
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)
MDS-UPDRS scale (part II : 2.13 and part III : 3.11)
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
MDS-UPDRS scale (part I)
Time frame: Baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
MDS-UPDRS scale (part I)
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
MDS-UPDRS scale (part I)
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
NMS SCALE
Time frame: baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
NMS SCALE
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
NMS SCALE
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Scopa-Aut Score
Time frame: baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Scopa-Aut Score
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Scopa-Aut Score
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Evaluation of constipation according to Rome III criteria
Time frame: Baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Evaluation of constipation according to Rome III criteria
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Evaluation of constipation according to Rome III criteria
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Detection of hypotension
Time frame: Baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Detection of hypotension
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Detection of hypotension
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders
Time frame: Baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders
Time frame: 24 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Epworth's Sleepiness Scale
Time frame: Baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Epworth's Sleepiness Scale
Time frame: 18 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Epworth's Sleepiness Scale
Time frame: 24 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
UPSIT test
Time frame: baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
UPSIT test
Time frame: 24 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
MoCA score
Time frame: Baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
MoCA score
Time frame: 18 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
MoCA score
Time frame: 24 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
MATTIS scale
Time frame: Baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
MATTIS scale
Time frame: 18 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
MATTIS scale
Time frame: 24 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Anxiety symptoms assessed using Beck's anxiety inventory
Time frame: Baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Anxiety symptoms assessed using Beck's anxiety inventory
Time frame: 18 months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Anxiety symptoms assessed using Beck's anxiety inventory
Time frame: 24 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Symptoms of depression assessed using the Beck Depression
Time frame: Baseline
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Symptoms of depression assessed using the Beck Depression
Time frame: 18 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)
Symptoms of depression assessed using the Beck Depression
Time frame: 24 Months
Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic denervation at baseline (DaTscan initial)
Dopaminergic denervation at inclusion will be measured by the binding potential (BP) of ioflupane (123I-FP-CIT) by regions of interest in the caudate and putamen of the striatum
Time frame: Baseline
Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57
MDS-UPDRS scale
Time frame: 24 Months
Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57
QUIP questionnaire
Time frame: 24 Months
Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57
NMS questionnaire
Time frame: 24 Months
Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57
Scopa-Aut Score
Time frame: 24 Months
Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57
Rome III criteria
Time frame: 24 Months
Evaluate the link between the level of striatal microglial activation and the level of activation in other brain regions (black substance, bridge and cortex)
The level of cortical microglial activation measured by fixation of the radioligand 18F-DPA-714, on some volumes of interest in the brain
Time frame: 24 months
Assess the relationship between the level of microglial activation in the extra-striatal cortical (cortex and brain stem) regions and the presence of non-motor and axial motor symptoms.
Neurologic Evaluation
Time frame: baseline
Assess the relationship between the level of microglial activation in the extra-striatal cortical (cortex and brain stem) regions and the presence of non-motor and axial motor symptoms.
Neurologic Evaluation
Time frame: 18 months
Assess the relationship between the level of microglial activation in the extra-striatal cortical (cortex and brain stem) regions and the presence of non-motor and axial motor symptoms.
Neurologic Evaluation
Time frame: 24 months
Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation
The serum levels of 13 cytokines will be analyzed
Time frame: Baseline
Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation Evaluate the relationship between the level of nigrostriatal microglial activation
The serum levels of 13 cytokines will be analyzed
Time frame: 18 months
Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation
The serum levels of 13 cytokines will be analyzed
Time frame: 24 months
Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months
Measurement of serum uric acid
Time frame: Baseline
Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months
Measurement of serum uric acid
Time frame: 18 months
Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months
Measurement of serum uric acid
Time frame: 24 months