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Report for Clinical Trial NCT03230526
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Brain Microglial Activation in the Early Stage of the Parkinson's Disease: a Predictive Biomarker of the Evolution?
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).
NCT03230526 Parkinson Disease MeSH:Parkinson Disease
1 Interventions
Name: [18F]DPA-714 PET scan
Primary Outcomes
Description: 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
Measure: Coefficient of correlation between level of microglial striatal activation and the And the dopaminergic denervation kinetics Time: 36 monthsSecondary Outcomes
Description: Will be estimated by imaging PET with [18F]DPA-714
Measure: Analyze the relationship between the level of microglial activation in the black substance at the early stage of MP and the dopaminergic denervation kinetics Time: 36 monthsDescription: The equivalent dose of cumulative L-Dopa
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors) Time: baselineDescription: The equivalent dose of cumulative L-Dopa
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors) Time: 18 monthsDescription: The equivalent dose of cumulative L-Dopa
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors) Time: 36 monthsDescription: MDS-UPDRS scale (part III "OFF" - Part III "ON" and part II)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors) Time: BaselineDescription: MDS-UPDRS scale (part III "OFF" - Part III "ON" and part II)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors) Time: 18 MonthsDescription: MDS-UPDRS scale (part III "OFF" - Part III "ON" and part II)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors) Time: 36 MonthsDescription: MDS-UPDRS scale (part IV)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors) Time: baselineDescription: MDS-UPDRS scale (part IV)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors) Time: 18 monthsDescription: MDS-UPDRS scale (part IV)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors) Time: 36 monthsDescription: QUIP RS
Measure: Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors) Time: baselineDescription: QUIP RS
Measure: Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors) Time: 18 monthsDescription: QUIP RS
Measure: Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors) Time: 36 monthsDescription: MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor) Time: baselineDescription: MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor) Time: 18 monthsDescription: MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor) Time: 36 monthsDescription: MDS-UPDRS scale (part II : 2.13 and part III : 3.11)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor) Time: baselineDescription: MDS-UPDRS scale (part II : 2.13 and part III : 3.11)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor) Time: 18 monthsDescription: MDS-UPDRS scale (part II : 2.13 and part III : 3.11)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor) Time: 36 monthsDescription: MDS-UPDRS scale (part I)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: BaselineDescription: MDS-UPDRS scale (part I)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 monthsDescription: MDS-UPDRS scale (part I)
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 monthsDescription: NMS SCALE
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: baselineDescription: NMS SCALE
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 monthsDescription: NMS SCALE
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 monthsDescription: Scopa-Aut Score
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: baselineDescription: Scopa-Aut Score
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 monthsDescription: Scopa-Aut Score
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 monthsDescription: Evaluation of constipation according to Rome III criteria
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: BaselineDescription: Evaluation of constipation according to Rome III criteria
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 monthsDescription: Evaluation of constipation according to Rome III criteria
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 monthsDescription: Detection of hypotension
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: BaselineDescription: Detection of hypotension
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 monthsDescription: Detection of hypotension
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 monthsDescription: Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: BaselineDescription: Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 monthsDescription: Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 monthsDescription: Epworth's Sleepiness Scale
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: BaselineDescription: Epworth's Sleepiness Scale
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 MonthsDescription: Epworth's Sleepiness Scale
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 MonthsDescription: UPSIT test
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: baselineDescription: UPSIT test
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 MonthsDescription: MoCA score
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: BaselineDescription: MoCA score
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 MonthsDescription: MoCA score
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 MonthsDescription: MATTIS scale
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: BaselineDescription: MATTIS scale
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 MonthsDescription: MATTIS scale
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 MonthsDescription: Anxiety symptoms assessed using Beck's anxiety inventory
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: BaselineDescription: Anxiety symptoms assessed using Beck's anxiety inventory
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 monthsDescription: Anxiety symptoms assessed using Beck's anxiety inventory
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 MonthsDescription: Symptoms of depression assessed using the Beck Depression
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: BaselineDescription: Symptoms of depression assessed using the Beck Depression
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 18 MonthsDescription: Symptoms of depression assessed using the Beck Depression
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor) Time: 36 MonthsDescription: 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
Measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic denervation at baseline (DaTscan initial) Time: BaselineDescription: MDS-UPDRS scale
Measure: Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57 Time: 36 MonthsDescription: QUIP questionnaire
Measure: Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57 Time: 36 MonthsDescription: NMS questionnaire
Measure: Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57 Time: 36 MonthsDescription: Scopa-Aut Score
Measure: Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57 Time: 36 MonthsDescription: Rome III criteria
Measure: Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57 Time: 36 MonthsDescription: The level of cortical microglial activation measured by fixation of the radioligand 18F-DPA-714, on some volumes of interest in the brain
Measure: Evaluate the link between the level of striatal microglial activation and the level of activation in other brain regions (black substance, bridge and cortex) Time: 36 monthsDescription: Neurologic Evaluation
Measure: 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. Time: baselineDescription: Neurologic Evaluation
Measure: 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. Time: 18 monthsDescription: Neurologic Evaluation
Measure: 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. Time: 36 monthsDescription: The serum levels of 13 cytokines will be analyzed
Measure: Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation Time: BaselineDescription: The serum levels of 13 cytokines will be analyzed
Measure: 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 Time: 18 monthsDescription: The serum levels of 13 cytokines will be analyzed
Measure: Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation Time: 36 monthsDescription: Measurement of serum uric acid
Measure: Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months Time: BaselineDescription: Measurement of serum uric acid
Measure: Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months Time: 18 monthsDescription: Measurement of serum uric acid
Measure: Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months Time: 36 monthsPurpose: Diagnostic
Allocation: Non-Randomized
Single Group Assignment
There is one SNP
SNPs
1 rs6971
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 Inclusion Criteria: - Patients having a Parkinson's disease diagnosed according to the criteria UKPDSBB.
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 Parkinson Disease Parkinson Disease The Parkinson's disease ( MP) is a frequent but heterogeneous neurodegenerative disease in term of clinical presentation(display) and evolutionary profile.