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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

Description: One PET scan using [18F]DPA-714 is done at M2 between two [123I]FP-CIT scan (DaTscan) done at M1 and M35. Neuropsychological assessment is done at M0, M18 and M36
Type: Drug


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 months

Secondary 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 months

Description: 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: baseline

Description: 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 months

Description: 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 months

Description: 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: Baseline

Description: 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 Months

Description: 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 Months

Description: 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: baseline

Description: 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 months

Description: 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 months

Description: QUIP RS

Measure: Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)

Time: baseline

Description: 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 months

Description: 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 months

Description: 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: baseline

Description: 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 months

Description: 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 months

Description: 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: baseline

Description: 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 months

Description: 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 months

Description: 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: Baseline

Description: 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 months

Description: 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 months

Description: 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: baseline

Description: 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 months

Description: 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 months

Description: 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: baseline

Description: 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 months

Description: 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 months

Description: 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: Baseline

Description: 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 months

Description: 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 months

Description: 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: Baseline

Description: 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 months

Description: 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 months

Description: 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: Baseline

Description: 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 months

Description: 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 months

Description: 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: Baseline

Description: 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 Months

Description: 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 Months

Description: 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: baseline

Description: 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 Months

Description: 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: Baseline

Description: 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 Months

Description: 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 Months

Description: 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: Baseline

Description: 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 Months

Description: 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 Months

Description: 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: Baseline

Description: 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 months

Description: 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 Months

Description: 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: Baseline

Description: 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 Months

Description: 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 Months

Description: 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: Baseline

Description: 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 Months

Description: QUIP questionnaire

Measure: Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57

Time: 36 Months

Description: NMS questionnaire

Measure: Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57

Time: 36 Months

Description: 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 Months

Description: 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 Months

Description: 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 months

Description: 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: baseline

Description: 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 months

Description: 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 months

Description: 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: Baseline

Description: 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 months

Description: 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 months

Description: 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: Baseline

Description: 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 months

Description: 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 months

Purpose: 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.



HPO Nodes