<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/NCT02263287</url>
  </required_header>
  <id_info>
    <org_study_id>RC14_0007</org_study_id>
    <nct_id>NCT02263287</nct_id>
  </id_info>
  <brief_title>LESCOD: &quot;Lewy Body Screening in Cognitive Disorders&quot;</brief_title>
  <acronym>LESCOD</acronym>
  <official_title>LESCOD: &quot;A Single Center, Prospective Study Aimed at Validating a Clinical Scale, Screening for Symptoms of Lewy Body Disease in Patients Incipient Dementia of the Alzheimer's and/or Lewy Body Type&quot;</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in autopsy&#xD;
      series. However, DLB represents a small proportion of the clinical diagnoses in epidemiology&#xD;
      registries. Indeed Alzheimer disease (AD) and DLB are often concomitant, they share many&#xD;
      symptoms and only a small weight is given to non-motor symptoms in DLB diagnosis. DLB is at&#xD;
      the end of a pathological spectrum overlapping with AD, explaining the poor diagnostic value&#xD;
      of both diagnostic criteria. To date there is still a need for a tool able to discriminate&#xD;
      patients with pure DLB from those expressing common signs with both AD and DLB and those with&#xD;
      pure AD. The purpose of this study is to validate a semi quantitative scale designed to&#xD;
      reflect the Lewy Bodies burden in patients with mild to moderate cognitive decline. The&#xD;
      investigators hypothesized that the score obtained may differentiate between AD, DLB and&#xD;
      patients fulfilling clinical criteria for both DLB an AD. This score could also be correlated&#xD;
      with dopaminergic depletion assessed with [18F]fluorodopa PET/computed tomography and/or with&#xD;
      potential biomarkers of ADD measured in cerebrospinal fluid. This clinical validation is a&#xD;
      preliminary work preceding further studies correlating the LeSCoD score with functional&#xD;
      imaging features, prognosis and therapeutic response. Thus, the expected outcomes involve an&#xD;
      improvement in demented patients' care, as well as a better patient selection for further&#xD;
      therapeutic studies&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitment problems&#xD;
  </why_stopped>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Construct validity of the LeSCoD scale with a factorial analysis</measure>
    <time_frame>Day 0 (during the inclusion visit)</time_frame>
    <description>The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic validity of the Lescod scale by measuring the sensitivity and the specificity</measure>
    <time_frame>Day 0 (During the inclusion visit)</time_frame>
    <description>The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intergroup variance will be used to assess the quality of the patient denomination</measure>
    <time_frame>Day 0 (during the inclusion visit)</time_frame>
    <description>The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concurrent validity will be assessed by the measurement of the striatal dopaminergic depletion and its correlation with the Lescod score</measure>
    <time_frame>Day 0 (during the inclusion visit)</time_frame>
    <description>The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Lewy Body Disease</condition>
  <arm_group>
    <arm_group_label>Alzheimer disease (AD)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with AD according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria Intervention: LeSCoD scale</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dementia with Lewy Bodies (DLB)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with probable DLB according to McKeith criteria. Intervention: LeSCoD scale</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probable AD and possible DLB</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with clinical criteria for possible or probable AD and possible DLB Intervention: LeSCoD scale</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LeSCoD scale</intervention_name>
    <description>LeSCoD is a clinical scale</description>
    <arm_group_label>Alzheimer disease (AD)</arm_group_label>
    <arm_group_label>Dementia with Lewy Bodies (DLB)</arm_group_label>
    <arm_group_label>Probable AD and possible DLB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be a woman or a male &gt;60 to &lt; 90 years&#xD;
&#xD;
          -  Have sufficient visual and auditory acuity&#xD;
&#xD;
          -  Be able to speak, read, hear and understand french language&#xD;
&#xD;
          -  Be covered by health care insurance&#xD;
&#xD;
          -  Have a reliable help/partner/informant/caregiver&#xD;
&#xD;
          -  Have a mild to severe cognitive decline based on MMSE (Mini-Mental State Examination)&#xD;
             score ( From 18 to 26)&#xD;
&#xD;
          -  Give oral agreement to the assessment of the LEsCoD scale during routine consultation&#xD;
&#xD;
          -  Have performed neuropsychology tests and MRI respectively within 6 and 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has evidence of neurological or psychiatric disorder other than AD or DLB explaining&#xD;
             cognitive decline&#xD;
&#xD;
          -  Has received previously or currently neuroleptic treatment&#xD;
&#xD;
          -  Has no reliable help/caregiver the day of the visit&#xD;
&#xD;
          -  Refuses to give his/her oral agreement to the assessment of the LeSCoD scale&#xD;
&#xD;
          -  Has presence on MRI of radiologic evidence of cerebrovascular disease (score Fazekas&#xD;
             2)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah EVAIN, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Nantes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>December 5, 2017</last_update_submitted>
  <last_update_submitted_qc>December 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer Disease</keyword>
  <keyword>Lewy Body Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Lewy Body 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/NCT02263287
org study id: RC14_0007
nct id: NCT02263287
lead sponsor: 
has dmc: No
Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in autopsy
      series. However, DLB represents a small proportion of the clinical diagnoses in epidemiology
      registries. Indeed Alzheimer disease (AD) and DLB are often concomitant, they share many
      symptoms and only a small weight is given to non-motor symptoms in DLB diagnosis. DLB is at
      the end of a pathological spectrum overlapping with AD, explaining the poor diagnostic value
      of both diagnostic criteria. To date there is still a need for a tool able to discriminate
      patients with pure DLB from those expressing common signs with both AD and DLB and those with
      pure AD. The purpose of this study is to validate a semi quantitative scale designed to
      reflect the Lewy Bodies burden in patients with mild to moderate cognitive decline. The
      investigators hypothesized that the score obtained may differentiate between AD, DLB and
      patients fulfilling clinical criteria for both DLB an AD. This score could also be correlated
      with dopaminergic depletion assessed with [18F]fluorodopa PET/computed tomography and/or with
      potential biomarkers of ADD measured in cerebrospinal fluid. This clinical validation is a
      preliminary work preceding further studies correlating the LeSCoD score with functional
      imaging features, prognosis and therapeutic response. Thus, the expected outcomes involve an
      improvement in demented patients' care, as well as a better patient selection for further
      therapeutic studies
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Construct validity of the LeSCoD scale with a factorial analysis
time frame: Day 0 (during the inclusion visit)
description: The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
measure: Diagnostic validity of the Lescod scale by measuring the sensitivity and the specificity
time frame: Day 0 (During the inclusion visit)
description: The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
measure: Intergroup variance will be used to assess the quality of the patient denomination
time frame: Day 0 (during the inclusion visit)
description: The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
measure: Concurrent validity will be assessed by the measurement of the striatal dopaminergic depletion and its correlation with the Lescod score
time frame: Day 0 (during the inclusion visit)
description: The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
arm group label: Alzheimer disease (AD)
arm group type: Other
description: Patients with AD according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria Intervention: LeSCoD scale
arm group label: Dementia with Lewy Bodies (DLB)
arm group type: Other
description: Patients with probable DLB according to McKeith criteria. Intervention: LeSCoD scale
arm group label: Probable AD and possible DLB
arm group type: Other
description: Patients with clinical criteria for possible or probable AD and possible DLB Intervention: LeSCoD scale
intervention type: Other
intervention name: LeSCoD scale
description: LeSCoD is a clinical scale
arm group label: Alzheimer disease (AD)
arm group label: Dementia with Lewy Bodies (DLB)
arm group label: Probable AD and possible DLB
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sarah EVAIN, Doctor
role: Study Chair
affiliation: Nantes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Lewy Body Disease