<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/NCT02196116</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2013/02</org_study_id>
    <nct_id>NCT02196116</nct_id>
  </id_info>
  <brief_title>Amyloïd Load in Elderly Population: Effect of Cognitive Reserve</brief_title>
  <acronym>EDUMA</acronym>
  <official_title>Amyloïd Load in Elderly Population: Effect of Cognitive Reserve</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation Plan Alzheimer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Electric</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research aim to explore relationships between the presence of amyloid burden and&#xD;
      cognitive performance, and its modulation by educational level. For this purpose we will&#xD;
      combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired&#xD;
      on 3 groups of subjects, from two population-based cohorts &quot;3C&quot; and &quot;AMIMage&quot; The first group&#xD;
      includes cognitively intact participants who will serve as controls, the second group,&#xD;
      subjects with mild cognitive impairments without memory complaint and the third, subjects&#xD;
      with both mild cognitive impairments and memory complaint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Influence of educational level on the relationship between disease-specific lesion&#xD;
      development and cognitive function will be assessed, as measured by amyloid PET imaging and a&#xD;
      battery of neuropsychological tests at the very early stages of the disease, comparatively to&#xD;
      age-matched controls. In addition, this project will explore the influence of cognitive&#xD;
      complaint.&#xD;
&#xD;
      It's assumed that 1) the amyloid-PET measures in age-matched controls and subjects from the&#xD;
      two cohorts will correlate with cognitive performances; 2) the amyloid burden will be higher&#xD;
      in high- than in low-educated subjects with similar cognitive impairment; and 3) similarly&#xD;
      the amyloid burden will be higher in subjects with cognitive complaint compared to subjects&#xD;
      without cognitive complaint.&#xD;
&#xD;
      Considering a longer term, the clinical follow-up of study participants will allow to&#xD;
      investigate the prognosis value of amyloid load for improving the prediction of cognitive&#xD;
      decline and disease progression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2016</primary_completion_date>
  <phase>N/A</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amyloid load</measure>
    <time_frame>at inclusion (day 0)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological scores</measure>
    <time_frame>At inclusion (Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Educational level</measure>
    <time_frame>At inclusion (Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory complaint</measure>
    <time_frame>At inclusion (Day 0)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Plaque, Amyloid</condition>
  <condition>Cognitive Deficits</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Controls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitively-impaired subjects without dementia and without memory</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitively-impaired subjects without dementia and with memory</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PET</intervention_name>
    <description>PET Scan with [18F]-Flutemetamol</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>neuropsychological tests</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participation in the AMI or 3C cohorts Group 1- Controls&#xD;
&#xD;
          -  MMSE &gt; 24 or &gt; 26 for low and high levels of education, respectively.&#xD;
&#xD;
          -  Without memory impairment (for episodic memory) on the Free and Cued Selective&#xD;
             Reminding Test RL/RI-16 items (FCSRT), free recall &gt; 22 and total recall &gt;42,&#xD;
             according to the thresholds for population-based studies&#xD;
&#xD;
          -  Without memory complaint&#xD;
&#xD;
          -  Without dementia Group 2- Cognitively-impaired subjects without dementia and without&#xD;
             memory complaints&#xD;
&#xD;
          -  Mini Mental State Evaluation (MMSE) &lt; 24 or &lt; 26 for low and high levels of education,&#xD;
             respectively&#xD;
&#xD;
          -  With memory impairments according to the RL/RI-16 test (free recall≤22 and/or total&#xD;
             recall ≤42), according to the thresholds for population-based studies defined by&#xD;
             Auriacombe et al., 2010.&#xD;
&#xD;
          -  Without memory complaint&#xD;
&#xD;
          -  Without dementia Group 3- Cognitively-impaired subjects without dementia and with&#xD;
             memory complaints&#xD;
&#xD;
          -  MMSE &lt; 24 or &lt; 26 for low and high levels of education, respectively&#xD;
&#xD;
          -  With memory impairments according to the RL/RI-16 test (same thresholds as above)&#xD;
&#xD;
          -  With memory complaint&#xD;
&#xD;
          -  Without dementia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being left handed&#xD;
&#xD;
          -  Presence of dementia (based on the clinical diagnosis)&#xD;
&#xD;
          -  Presence of stroke&#xD;
&#xD;
          -  Presence of Parkinson's disease&#xD;
&#xD;
          -  Presence of a counter-indication for MRI&#xD;
&#xD;
          -  Presence of a counter-indication for PET Scan with [18F]-Flutemetamol&#xD;
&#xD;
          -  Presence of any health problem preventing travel to the imaging service of the&#xD;
             University Hospital&#xD;
&#xD;
          -  Being under the legal guardianship of another person or being unable to provide&#xD;
             consent to participate&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michèle ALLARD, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michèle ALLARD, MD-PhD</last_name>
    <email>Michele.allard@chu-bordeaux.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Caroline BUISSON, CRA</last_name>
    <email>caroline.buisson@chu-bordeaux.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michele ALLARD, MD</last_name>
      <email>michele.allard@chu-bordeaux.fr</email>
    </contact>
    <investigator>
      <last_name>Michèle ALLARD, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-François DARTIGUES, Md, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philippe FERNANDEZ, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Simon ARNOULD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Henri De CLERMONT GALLERANDE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paolo ZANOTTI FREGONARA, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Igor SIBON, MD,PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexandra FOUBERT, Md</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>February 11, 2015</last_update_submitted>
  <last_update_submitted_qc>February 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer disease</keyword>
  <keyword>amyloid load</keyword>
  <keyword>educational level</keyword>
  <keyword>cognitive performances</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amyloidosis</mesh_term>
    <mesh_term>Plaque, Amyloid</mesh_term>
    <mesh_term>Cognition Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT02196116
org study id: CHUBX 2013/02
nct id: NCT02196116
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This research aim to explore relationships between the presence of amyloid burden and
      cognitive performance, and its modulation by educational level. For this purpose we will
      combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired
      on 3 groups of subjects, from two population-based cohorts "3C" and "AMIMage" The first group
      includes cognitively intact participants who will serve as controls, the second group,
      subjects with mild cognitive impairments without memory complaint and the third, subjects
      with both mild cognitive impairments and memory complaint.
Influence of educational level on the relationship between disease-specific lesion
      development and cognitive function will be assessed, as measured by amyloid PET imaging and a
      battery of neuropsychological tests at the very early stages of the disease, comparatively to
      age-matched controls. In addition, this project will explore the influence of cognitive
      complaint.

      It's assumed that 1) the amyloid-PET measures in age-matched controls and subjects from the
      two cohorts will correlate with cognitive performances; 2) the amyloid burden will be higher
      in high- than in low-educated subjects with similar cognitive impairment; and 3) similarly
      the amyloid burden will be higher in subjects with cognitive complaint compared to subjects
      without cognitive complaint.

      Considering a longer term, the clinical follow-up of study participants will allow to
      investigate the prognosis value of amyloid load for improving the prediction of cognitive
      decline and disease progression.
allocation: Non-Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Amyloid load
time frame: at inclusion (day 0)
measure: Neuropsychological scores
time frame: At inclusion (Day 0)
measure: Educational level
time frame: At inclusion (Day 0)
measure: Memory complaint
time frame: At inclusion (Day 0)
arm group label: Group 1
arm group type: Active Comparator
description: Controls
arm group label: Group 2
arm group type: Experimental
description: Cognitively-impaired subjects without dementia and without memory
arm group label: Group 3
arm group type: Experimental
description: Cognitively-impaired subjects without dementia and with memory
intervention type: Other
intervention name: PET
description: PET Scan with [18F]-Flutemetamol
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
intervention type: Other
intervention name: MRI
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
intervention type: Other
intervention name: neuropsychological tests
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michèle ALLARD, MD-PhD
role: Principal Investigator
affiliation: University Hospital, Bordeaux
last name: Michèle ALLARD, MD-PhD
email: Michele.allard@chu-bordeaux.fr
last name: Caroline BUISSON, CRA
email: caroline.buisson@chu-bordeaux.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Amyloidosis
mesh term: Plaque, Amyloid
mesh term: Cognition Disorders
mesh term: Cognitive Dysfunction