<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/NCT02221661</url>
  </required_header>
  <id_info>
    <org_study_id>MG/JD/11.830</org_study_id>
    <nct_id>NCT02221661</nct_id>
  </id_info>
  <brief_title>Performance of AclarusDx® a Blood-Based Transcriptomic Test for AD, in French Patients Newly Referred to a Memory Center</brief_title>
  <acronym>DIALOG</acronym>
  <official_title>Non-interventional Longitudinal Study in Alzheimer Disease Diagnosis in Primary Consultants Patients With Cognitive and / or Memory Complaint Requiring Specialized Exploration Using AclarusDx® Blood Test in Memory Centers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diaxonhit</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Olivier SOL, MD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Diaxonhit</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the performance of AclarusDx™, an investigational&#xD;
      blood test detecting gene expression information, and intended to help physicians in making&#xD;
      an Alzheimer's Disease diagnosis in patients having memory complaint and/or cognitive&#xD;
      impairments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to apply AclarusDx™ signature in 600 patients newly referred&#xD;
      in french memory centers. Only AclarusDx™ will be added to the panel of tests usually&#xD;
      performed at the centers to establish diagnosis. AclarusDx™ will be used for investigational&#xD;
      use only, not for diagnostic purpose. The ultimate goal is to define the clinical utility of&#xD;
      AclarusDx™ to provide physicians with a tool that will help them in making the diagnosis of&#xD;
      Alzheimer's Disease (AD).&#xD;
&#xD;
      The primary objective is to estimate the prevalence of positive AclarusDx™ in patients&#xD;
      diagnosed AD in the population of primary consultants. This population of primary consultants&#xD;
      consists of patients with cognitive impairment and / or a memory complaint requiring&#xD;
      specialized exploration using AclarusDx™ blood test and which may be potentially related to&#xD;
      multiple and different etiologies.&#xD;
&#xD;
      The secondary objectives are:&#xD;
&#xD;
        -  Assess the prevalence of positive AclarusDx™ in relation to other diagnoses (MCI,&#xD;
           vascular dementia ...) established by the physician investigator at the end of&#xD;
           specialized assessment.&#xD;
&#xD;
        -  Identify the demographic factors anamnestic, clinical, biological and imaging associated&#xD;
           with positivity of AclarusDx™&#xD;
&#xD;
        -  Identify the demographic factors anamnestic, clinical, biological and imaging associated&#xD;
           with the diagnosis of AD and other diagnoses.&#xD;
&#xD;
        -  Determine the contribution of AclarusDx™ in the usual battery of tests performed for&#xD;
           diagnostic approach to Alzheimer's disease and to identify a possible association of&#xD;
           interest with one or more endpoints (clinical, neuropsychological, brain, biological&#xD;
           imaging).&#xD;
&#xD;
        -  Assess: diagnostic status at 6 and 12 months, and the MMSE and IADL at 6 and 12 months.&#xD;
&#xD;
        -  assess the predictive value of AclarusDx™ achieved during the initial visit to the&#xD;
           diagnosis of AD is 12 months.&#xD;
&#xD;
        -  Evaluate AclarusDx™ predictive value to 12 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Estimation of the prevalence of positive AclarusDx™ among patients clinically AD diagnosed</measure>
    <time_frame>Outcome measured during one single study visit</time_frame>
    <description>The primary outcome is to estimate the prevalence of positive AclarusDx Alzheimer patients diagnosed (excluding MCI).&#xD;
The prevalence is estimated as a percentage calculated among patients being confirmed clinically as having AD at the Memory Center and having a positive or negative AclarusDx™ result</description>
  </primary_outcome>
  <enrollment type="Actual">606</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Memory Complaint</condition>
  <condition>Clinical Investigation in Memory Centers</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood samples collected in PAXgene® blood RNA tubes&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with cognitive impairment and/or memory complaint justifying a first clinical&#xD;
        investigation for diagnosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male and female adult patients&#xD;
&#xD;
          -  suffering from cognitive impairment and/or memory complaint and justifying a first&#xD;
             clinical investigation at the memory center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient already followed up by the memory center&#xD;
&#xD;
          -  patient unable to comply with study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer</keyword>
  <keyword>cognitive impairment</keyword>
  <keyword>blood test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02221661
org study id: MG/JD/11.830
nct id: NCT02221661
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to assess the performance of AclarusDx™, an investigational
      blood test detecting gene expression information, and intended to help physicians in making
      an Alzheimer's Disease diagnosis in patients having memory complaint and/or cognitive
      impairments.
The objective of this study is to apply AclarusDx™ signature in 600 patients newly referred
      in french memory centers. Only AclarusDx™ will be added to the panel of tests usually
      performed at the centers to establish diagnosis. AclarusDx™ will be used for investigational
      use only, not for diagnostic purpose. The ultimate goal is to define the clinical utility of
      AclarusDx™ to provide physicians with a tool that will help them in making the diagnosis of
      Alzheimer's Disease (AD).

      The primary objective is to estimate the prevalence of positive AclarusDx™ in patients
      diagnosed AD in the population of primary consultants. This population of primary consultants
      consists of patients with cognitive impairment and / or a memory complaint requiring
      specialized exploration using AclarusDx™ blood test and which may be potentially related to
      multiple and different etiologies.

      The secondary objectives are:

        -  Assess the prevalence of positive AclarusDx™ in relation to other diagnoses (MCI,
           vascular dementia ...) established by the physician investigator at the end of
           specialized assessment.

        -  Identify the demographic factors anamnestic, clinical, biological and imaging associated
           with positivity of AclarusDx™

        -  Identify the demographic factors anamnestic, clinical, biological and imaging associated
           with the diagnosis of AD and other diagnoses.

        -  Determine the contribution of AclarusDx™ in the usual battery of tests performed for
           diagnostic approach to Alzheimer's disease and to identify a possible association of
           interest with one or more endpoints (clinical, neuropsychological, brain, biological
           imaging).

        -  Assess: diagnostic status at 6 and 12 months, and the MMSE and IADL at 6 and 12 months.

        -  assess the predictive value of AclarusDx™ achieved during the initial visit to the
           diagnosis of AD is 12 months.

        -  Evaluate AclarusDx™ predictive value to 12 months
observational model: Case-Only
time perspective: Cross-Sectional
measure: Estimation of the prevalence of positive AclarusDx™ among patients clinically AD diagnosed
time frame: Outcome measured during one single study visit
description: The primary outcome is to estimate the prevalence of positive AclarusDx Alzheimer patients diagnosed (excluding MCI).
The prevalence is estimated as a percentage calculated among patients being confirmed clinically as having AD at the Memory Center and having a positive or negative AclarusDx™ result
Whole blood samples collected in PAXgene® blood RNA tubes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cognitive Dysfunction