<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03230526</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0012</org_study_id>
    <secondary_id>2017-000411-16</secondary_id>
    <nct_id>NCT03230526</nct_id>
  </id_info>
  <brief_title>Identification of a Biomarker Predictive of Evolution of Parkinson Disease</brief_title>
  <acronym>GLIAPARK</acronym>
  <official_title>Brain Microglial Activation in the Early Stage of the Parkinson's Disease: a Predictive Biomarker of the Evolution?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase II, Open-labeled, Prospective, Multi-center study of assessing the link between&#xD;
      microglial activation and dopaminergic denervation kinetics in the early stage of Parkinson&#xD;
      disease, by using the imaging of [18F]DPA-714 a new ligand of Translocator Protein-18 kDa&#xD;
      (TSPO) by Positron Emission Tomography (PET).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Parkinson's disease ( MP) is a frequent but heterogeneous neurodegenerative disease in&#xD;
      term of clinical presentation(display) and evolutionary profile. The therapeutic&#xD;
      coverage(care) of the patients would thus be personalized Such an approach remains still in&#xD;
      its infancy in 2017. Better know the factors which determine the evolutionary clinical&#xD;
      subcategories is a major question of the current researches on the Parkinson disease.&#xD;
      Nigrostriaial inflammation is an interesting candidate. Microglia activation is closely&#xD;
      associated with the degenerative process.&#xD;
&#xD;
      Development of the molecular imaging allows to study nigrostriatal inflammation in vivo in&#xD;
      human by positron emission tomography (PET) by using the radiotracer of the protein of&#xD;
      translocation of 18KDa ( TSPO), considered as a marker of microglia activation Some studies&#xD;
      showed an increase of the inflammation in the striatum and in the substantia nigra, the sites&#xD;
      of the dopaminergic degeneration (The lesional core of the Parkinson disease is the damage of&#xD;
      the dopaminergic nigrostriatale way). However data remain rare and concern small number of&#xD;
      patients. Some data are inconsistent because of problems of specificity of the ligands used&#xD;
      and variation between populations of studied patients (duration of disease evolution).&#xD;
&#xD;
      In this study, investigators suggest studying by imaging TEP using a ligand new of the TSPO,&#xD;
      [18F]DPA-714, microglial brain activation in the early stage of the Parkinson disease and&#xD;
      determine wether it is predictive of speed of disease progression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 16, 2018</start_date>
  <completion_date type="Anticipated">October 16, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 16, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Coefficient of correlation between level of microglial striatal activation and the And the dopaminergic denervation kinetics</measure>
    <time_frame>36 months</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>36 months</time_frame>
    <description>Will be estimated by imaging PET with [18F]DPA-714</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)</measure>
    <time_frame>baseline</time_frame>
    <description>The equivalent dose of cumulative L-Dopa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)</measure>
    <time_frame>18 months</time_frame>
    <description>The equivalent dose of cumulative L-Dopa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)</measure>
    <time_frame>36 months</time_frame>
    <description>The equivalent dose of cumulative L-Dopa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)</measure>
    <time_frame>Baseline</time_frame>
    <description>MDS-UPDRS scale (part III &quot;OFF&quot; - Part III &quot;ON&quot; and part II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)</measure>
    <time_frame>18 Months</time_frame>
    <description>MDS-UPDRS scale (part III &quot;OFF&quot; - Part III &quot;ON&quot; and part II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)</measure>
    <time_frame>36 Months</time_frame>
    <description>MDS-UPDRS scale (part III &quot;OFF&quot; - Part III &quot;ON&quot; and part II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)</measure>
    <time_frame>baseline</time_frame>
    <description>MDS-UPDRS scale (part IV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)</measure>
    <time_frame>18 months</time_frame>
    <description>MDS-UPDRS scale (part IV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)</measure>
    <time_frame>36 months</time_frame>
    <description>MDS-UPDRS scale (part IV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)</measure>
    <time_frame>baseline</time_frame>
    <description>QUIP RS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)</measure>
    <time_frame>18 months</time_frame>
    <description>QUIP RS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)</measure>
    <time_frame>36 months</time_frame>
    <description>QUIP RS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)</measure>
    <time_frame>baseline</time_frame>
    <description>MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)</measure>
    <time_frame>18 months</time_frame>
    <description>MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)</measure>
    <time_frame>36 months</time_frame>
    <description>MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)</measure>
    <time_frame>baseline</time_frame>
    <description>MDS-UPDRS scale (part II : 2.13 and part III : 3.11)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)</measure>
    <time_frame>18 months</time_frame>
    <description>MDS-UPDRS scale (part II : 2.13 and part III : 3.11)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)</measure>
    <time_frame>36 months</time_frame>
    <description>MDS-UPDRS scale (part II : 2.13 and part III : 3.11)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>Baseline</time_frame>
    <description>MDS-UPDRS scale (part I)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 months</time_frame>
    <description>MDS-UPDRS scale (part I)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 months</time_frame>
    <description>MDS-UPDRS scale (part I)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>baseline</time_frame>
    <description>NMS SCALE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 months</time_frame>
    <description>NMS SCALE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 months</time_frame>
    <description>NMS SCALE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>baseline</time_frame>
    <description>Scopa-Aut Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 months</time_frame>
    <description>Scopa-Aut Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 months</time_frame>
    <description>Scopa-Aut Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>Baseline</time_frame>
    <description>Evaluation of constipation according to Rome III criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 months</time_frame>
    <description>Evaluation of constipation according to Rome III criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 months</time_frame>
    <description>Evaluation of constipation according to Rome III criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>Baseline</time_frame>
    <description>Detection of hypotension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 months</time_frame>
    <description>Detection of hypotension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 months</time_frame>
    <description>Detection of hypotension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>Baseline</time_frame>
    <description>Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 months</time_frame>
    <description>Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 months</time_frame>
    <description>Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>Baseline</time_frame>
    <description>Epworth's Sleepiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 Months</time_frame>
    <description>Epworth's Sleepiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 Months</time_frame>
    <description>Epworth's Sleepiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>baseline</time_frame>
    <description>UPSIT test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 Months</time_frame>
    <description>UPSIT test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>Baseline</time_frame>
    <description>MoCA score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 Months</time_frame>
    <description>MoCA score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 Months</time_frame>
    <description>MoCA score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>Baseline</time_frame>
    <description>MATTIS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 Months</time_frame>
    <description>MATTIS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 Months</time_frame>
    <description>MATTIS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>Baseline</time_frame>
    <description>Anxiety symptoms assessed using Beck's anxiety inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 months</time_frame>
    <description>Anxiety symptoms assessed using Beck's anxiety inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 Months</time_frame>
    <description>Anxiety symptoms assessed using Beck's anxiety inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>Baseline</time_frame>
    <description>Symptoms of depression assessed using the Beck Depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>18 Months</time_frame>
    <description>Symptoms of depression assessed using the Beck Depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)</measure>
    <time_frame>36 Months</time_frame>
    <description>Symptoms of depression assessed using the Beck Depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic denervation at baseline (DaTscan initial)</measure>
    <time_frame>Baseline</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57</measure>
    <time_frame>36 Months</time_frame>
    <description>MDS-UPDRS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57</measure>
    <time_frame>36 Months</time_frame>
    <description>QUIP questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57</measure>
    <time_frame>36 Months</time_frame>
    <description>NMS questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57</measure>
    <time_frame>36 Months</time_frame>
    <description>Scopa-Aut Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57</measure>
    <time_frame>36 Months</time_frame>
    <description>Rome III criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <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)</measure>
    <time_frame>36 months</time_frame>
    <description>The level of cortical microglial activation measured by fixation of the radioligand 18F-DPA-714, on some volumes of interest in the brain</description>
  </secondary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>baseline</time_frame>
    <description>Neurologic Evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>18 months</time_frame>
    <description>Neurologic Evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>36 months</time_frame>
    <description>Neurologic Evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation</measure>
    <time_frame>Baseline</time_frame>
    <description>The serum levels of 13 cytokines will be analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>18 months</time_frame>
    <description>The serum levels of 13 cytokines will be analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation</measure>
    <time_frame>36 months</time_frame>
    <description>The serum levels of 13 cytokines will be analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months</measure>
    <time_frame>Baseline</time_frame>
    <description>Measurement of serum uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months</measure>
    <time_frame>18 months</time_frame>
    <description>Measurement of serum uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months</measure>
    <time_frame>36 months</time_frame>
    <description>Measurement of serum uric acid</description>
  </secondary_outcome>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Parkinson Disease</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[18F]DPA-714 PET scan</intervention_name>
    <description>One PET scan using [18F]DPA-714 is done at M2 between two [123I]FP-CIT scan (DaTscan) done at M1 and M35.&#xD;
Neuropsychological assessment is done at M0, M18 and M36</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients having a Parkinson's disease diagnosed according to the criteria UKPDSBB.&#xD;
&#xD;
          -  Diagnosis done less than three years before the date the inclusion.&#xD;
&#xD;
          -  Patient Age at diagnosis : between 40 and 65 years.&#xD;
&#xD;
          -  Absence of clinical arguments for an associated neurovascular pathology.&#xD;
&#xD;
          -  Written consent obtained.&#xD;
&#xD;
          -  HAB polymorphism in the genotyping of TSPO gene.&#xD;
&#xD;
          -  Brain MRI without following abnormalities: cortical or sub-cortical atrophy or&#xD;
             hippocampal atrophy (Scheltens score ≥2), vascular encephalopathy (Fazekas score &gt; 2,&#xD;
             &gt; 10 microbleed) or showing signs in favour of atypical parkinson syndrome.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Minor&#xD;
&#xD;
          -  Adult protected by the law&#xD;
&#xD;
          -  Contraindication to PET-scan&#xD;
&#xD;
          -  Contraindication to brain MRI&#xD;
&#xD;
          -  History of inflammatory or dysimmune chronic disease&#xD;
&#xD;
          -  History of psychiatric disease or drug addiction&#xD;
&#xD;
          -  History of cognitive disorders (MMS&lt;26)&#xD;
&#xD;
          -  Hypersensibility to iodine derivates or one of these components&#xD;
&#xD;
          -  Long-term Treatments which can interfere in neuroinflammation process&#xD;
&#xD;
          -  Treatments / substances susceptible to interfere with the 18F-DPA-714&#xD;
&#xD;
          -  TSPO gene Polymorphisms rs6971 corresponding to groups of affinity of low affinity&#xD;
             (LAB=Low Affinity Binder) or moderated MAB = Mixed Affinity Binder)&#xD;
&#xD;
          -  Modification of diagnosis of Parkinson disease during follow-up, in particular towards&#xD;
             an atypical parkinson-like syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anne-Gaëlle CORBILLE, MD</last_name>
    <phone>+33240165212</phone>
    <email>anne-gaelle.corbille@chu-nantes.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Evelyne SCOTET-CERATO, PhD</last_name>
    <phone>+33253482840</phone>
    <email>evelyne.cerato@chu-nantes.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Gaëlle Corbille</last_name>
    </contact>
    <investigator>
      <last_name>Anne Gaëlle Corbille</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Eugène Marquis</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Florence Lejeune</last_name>
    </contact>
    <investigator>
      <last_name>Florence Lejeune</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marc Verin</last_name>
    </contact>
    <investigator>
      <last_name>Marc Verin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Luc HOUETO</last_name>
    </contact>
    <investigator>
      <last_name>Jean-Luc HOUETO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>September 17, 2021</last_update_submitted>
  <last_update_submitted_qc>September 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03230526
org study id: RC17_0012
secondary id: 2017-000411-16
nct id: NCT03230526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Coefficient of correlation between level of microglial striatal activation and the And the dopaminergic denervation kinetics
time frame: 36 months
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: 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 frame: 36 months
description: Will be estimated by imaging PET with [18F]DPA-714
measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)
time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 36 months
description: MDS-UPDRS scale (part IV)
measure: Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)
time frame: 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 frame: 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 frame: 36 months
description: QUIP RS
measure: Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)
time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 (non-motor)
time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 dopaminergic denervation at baseline (DaTscan initial)
time frame: Baseline
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 link between the level of microglial activation in the black substance and outcome 3 to outcome 57
time frame: 36 Months
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 frame: 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 frame: 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 frame: 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 frame: 36 Months
description: Rome III criteria
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 frame: 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: 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 frame: 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 frame: 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 frame: 36 months
description: Neurologic Evaluation
measure: Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation
time frame: 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 frame: 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 frame: 36 months
description: The serum levels of 13 cytokines will be analyzed
measure: Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months
time frame: 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 frame: 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 frame: 36 months
description: Measurement of serum uric acid
intervention type: Drug
intervention 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
criteria: 
gender: All
minimum age: 40 Years
maximum age: 67 Years
healthy volunteers: No
last name: Anne-Gaëlle CORBILLE, MD
phone: +33240165212
email: anne-gaelle.corbille@chu-nantes.fr
last name: Evelyne SCOTET-CERATO, PhD
phone: +33253482840
email: evelyne.cerato@chu-nantes.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease