<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/NCT03279835</url>
  </required_header>
  <id_info>
    <org_study_id>16-PP-09</org_study_id>
    <nct_id>NCT03279835</nct_id>
  </id_info>
  <brief_title>Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients</brief_title>
  <acronym>NEURACog</acronym>
  <official_title>Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this prospective study is to evaluate the prevalence of neurocognitive&#xD;
      impairments in HIV infected patients comparing patients with and without HAART. Recent&#xD;
      studies have demonstrated a specific HIV infected patients neurocognitive disorders profile.&#xD;
      These cognitive disorders concern primarily information processing speed, memory recall,&#xD;
      attentional abilities, work related memory, executive functions, and psychometrical speed.&#xD;
      This cognitive profile is similar to another highly documented one, described for another&#xD;
      central nervous system disease (CNS): multiple sclerosis. In both CNS diseases, the earliest&#xD;
      and most severe disorder is the one related to the information processing speed. For the&#xD;
      multiple sclerosis patients, a short cognitive test (SDMT) is actually used not only to&#xD;
      identify cognitive disorders presence, but also in order to predict a long term disability&#xD;
      worsening. A digital version of this test (CSCT), has recently been developed in order to&#xD;
      make this early evaluation easier. We hypothesize that CSCT alteration would also predict&#xD;
      HAND, in HIV infected patients. A complete neuropsychological assessment is highly time and&#xD;
      personal consuming. This short (approximatively 2 minutes) digital test would be highly&#xD;
      helpful to identify patients, who will need a more extensive neuropsychological assessment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2017</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive Speed Computerized Test (CSCT) score</measure>
    <time_frame>at patient inclusion</time_frame>
    <description>allows the evaluation of the speed of the processing of the information</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA) Score</measure>
    <time_frame>at patient inclusion</time_frame>
    <description>allows the evaluation of the overall cognitive functioning</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Paced Auditory Serial Addition Test (PASAT) score</measure>
    <time_frame>at patient inclusion</time_frame>
    <description>allows to evaluate the concentration capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Memory (WAIS-III location and back)</measure>
    <time_frame>at patient inclusion</time_frame>
    <description>short-term memory evaluation and verbal working memory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score RL-RI16</measure>
    <time_frame>at patient inclusion</time_frame>
    <description>allows the evaluation of episodic and long-term verbal memory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rey figure</measure>
    <time_frame>at patient inclusion</time_frame>
    <description>allows the evaluation of the long-term capacities of visio-construction (wealth score) and planning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TMTB - TMTA Time Score</measure>
    <time_frame>at patient inclusion</time_frame>
    <description>Assessment of Mental Flexibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal fluency test</measure>
    <time_frame>at patient inclusion</time_frame>
    <description>allows the evaluation of the verbal initiation and verbal language capacities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IADL score</measure>
    <time_frame>at patient inclusion</time_frame>
    <description>allows to evaluate the symptomatic character of the disorders</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">86</enrollment>
  <condition>HIV-1</condition>
  <arm_group>
    <arm_group_label>Absence of cognitive disorder</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Asymptomatic cognitive disorder</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Symptomatic cognitive impairment</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV associated dementia</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Classic evaluation of neurocognitive functions</intervention_name>
    <description>Symbol Digit Modalities Test (SDMT)</description>
    <arm_group_label>Absence of cognitive disorder</arm_group_label>
    <arm_group_label>Asymptomatic cognitive disorder</arm_group_label>
    <arm_group_label>HIV associated dementia</arm_group_label>
    <arm_group_label>Symptomatic cognitive impairment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>New evaluation of neurocognitive functions</intervention_name>
    <description>Cognitive Speed Computerized Test (CSCT)</description>
    <arm_group_label>Absence of cognitive disorder</arm_group_label>
    <arm_group_label>Asymptomatic cognitive disorder</arm_group_label>
    <arm_group_label>HIV associated dementia</arm_group_label>
    <arm_group_label>Symptomatic cognitive impairment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients infected with HIV-1&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients infected with HIV-1&#xD;
&#xD;
          -  Patients followed in outpatient service, over 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients infected with HIV-2&#xD;
&#xD;
          -  Patients with difficulty understanding the French language&#xD;
&#xD;
          -  Patients present with progressive opportunistic infection&#xD;
&#xD;
          -  Patients for whom a change of psychotropic treatment was performed in the last 3 weeks&#xD;
&#xD;
          -  Patients with drug and / or alcohol addiction&#xD;
&#xD;
          -  Patients with a history of psychiatric disorder&#xD;
&#xD;
          -  Patients with stroke, endocarditis or meningoencephalitis with severe neurological&#xD;
             sequelae&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Pasteur 2 - Service de Neurologie</name>
      <address>
        <city>Nice</city>
        <zip>06001</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>May 17, 2019</last_update_submitted>
  <last_update_submitted_qc>May 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2019</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>Cognitive Dysfunction</mesh_term>
    <mesh_term>Cognition Disorders</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/NCT03279835
org study id: 16-PP-09
nct id: NCT03279835
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this prospective study is to evaluate the prevalence of neurocognitive
      impairments in HIV infected patients comparing patients with and without HAART. Recent
      studies have demonstrated a specific HIV infected patients neurocognitive disorders profile.
      These cognitive disorders concern primarily information processing speed, memory recall,
      attentional abilities, work related memory, executive functions, and psychometrical speed.
      This cognitive profile is similar to another highly documented one, described for another
      central nervous system disease (CNS): multiple sclerosis. In both CNS diseases, the earliest
      and most severe disorder is the one related to the information processing speed. For the
      multiple sclerosis patients, a short cognitive test (SDMT) is actually used not only to
      identify cognitive disorders presence, but also in order to predict a long term disability
      worsening. A digital version of this test (CSCT), has recently been developed in order to
      make this early evaluation easier. We hypothesize that CSCT alteration would also predict
      HAND, in HIV infected patients. A complete neuropsychological assessment is highly time and
      personal consuming. This short (approximatively 2 minutes) digital test would be highly
      helpful to identify patients, who will need a more extensive neuropsychological assessment.
observational model: Other
time perspective: Prospective
measure: Cognitive Speed Computerized Test (CSCT) score
time frame: at patient inclusion
description: allows the evaluation of the speed of the processing of the information
measure: Montreal Cognitive Assessment (MoCA) Score
time frame: at patient inclusion
description: allows the evaluation of the overall cognitive functioning
measure: Paced Auditory Serial Addition Test (PASAT) score
time frame: at patient inclusion
description: allows to evaluate the concentration capacity
measure: Numeric Memory (WAIS-III location and back)
time frame: at patient inclusion
description: short-term memory evaluation and verbal working memory
measure: Score RL-RI16
time frame: at patient inclusion
description: allows the evaluation of episodic and long-term verbal memory
measure: Rey figure
time frame: at patient inclusion
description: allows the evaluation of the long-term capacities of visio-construction (wealth score) and planning
measure: TMTB - TMTA Time Score
time frame: at patient inclusion
description: Assessment of Mental Flexibility
measure: Verbal fluency test
time frame: at patient inclusion
description: allows the evaluation of the verbal initiation and verbal language capacities
measure: IADL score
time frame: at patient inclusion
description: allows to evaluate the symptomatic character of the disorders
arm group label: Absence of cognitive disorder
arm group label: Asymptomatic cognitive disorder
arm group label: Symptomatic cognitive impairment
arm group label: HIV associated dementia
intervention type: Other
intervention name: Classic evaluation of neurocognitive functions
description: Symbol Digit Modalities Test (SDMT)
arm group label: Absence of cognitive disorder
arm group label: Asymptomatic cognitive disorder
arm group label: HIV associated dementia
arm group label: Symptomatic cognitive impairment
intervention type: Other
intervention name: New evaluation of neurocognitive functions
description: Cognitive Speed Computerized Test (CSCT)
arm group label: Absence of cognitive disorder
arm group label: Asymptomatic cognitive disorder
arm group label: HIV associated dementia
arm group label: Symptomatic cognitive impairment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
mesh term: Cognition Disorders