<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/NCT01661660</url>
  </required_header>
  <id_info>
    <org_study_id>12-PP-01</org_study_id>
    <nct_id>NCT01661660</nct_id>
  </id_info>
  <brief_title>Ecological Assessment of Autonomy and Apathy</brief_title>
  <acronym>Dem@Care</acronym>
  <official_title>Ecological Assessment of Autonomy and Apathy in Alzheimer Patients at Mild and Moderate Stages, as Welle as in Healthy Control Particpants</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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive symptoms are the core feature of Alzheimer's disease. Besides these problems,&#xD;
      behavioural and psychological symptoms (BPSD), and an impairment of activities of daily&#xD;
      living (IADL) are frequently encountered and usually show an impact on autonomy maintenance,&#xD;
      prognostic and care during the prodromal and early stages of the disease.&#xD;
&#xD;
      Such symptoms are noticeable before the diagnosis of dementia and their occurrences as well&#xD;
      as their intensity increase with the evolution of the disease.&#xD;
&#xD;
      Apathy, initially defined as a reduction of motivated behaviours, is the most frequently&#xD;
      observed BPSD. Apathy is clinically defined by a significant reduction or complete loss of&#xD;
      interest, initiative capacity and emotional blunting. Accordingly, apathy is characterized by&#xD;
      diminished goal-directed cognitions and behaviours.&#xD;
&#xD;
      Behavioural and psychological assessment relies essentially on neuropsychiatric scales. These&#xD;
      are used to gather precise data regarding patient's clinical state from interviews with the&#xD;
      patient, the career or from clinical impressions during the consultation. From their apparent&#xD;
      simplicity they have made their way into daily clinical practices, yet neuropsychiatric&#xD;
      scales are reportedly biased by the assessors' subjectivity.&#xD;
&#xD;
      However, some tools whose allow simple, fast and objectively valid assessments are not widely&#xD;
      used.&#xD;
&#xD;
      Hence, the use of ICT such as actigraphy (wearable device assessing locomotion activities),&#xD;
      automatized audio-video recognition and signal analysis from events, may be of interest in&#xD;
      addition to current assessment methods.&#xD;
&#xD;
      The aim of this study is to implement an objective assessment of goal directed activities and&#xD;
      autonomy in an experimental design including predefined actions. The setting includes video&#xD;
      cameras, microphones, actigraphic and Galvanic Skin Response sensors for recording and&#xD;
      computer-based recognition of events using audio-video data, locomotion data and sinusal&#xD;
      variability respectively as well as extracting biomarkers for supporting detection of&#xD;
      dementia at early stages and supporting ongoing tracking of the dementia disease state. The&#xD;
      following population will be included: patients with Mild Cognitive Impairment (n=50),&#xD;
      patients with Alzheimer's disease (n=50) and control participants (n=50).&#xD;
&#xD;
      This work will provide further objective information for clinical practitioner in order to&#xD;
      detect behavioral disturbances such as apathy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2012</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the evaluation score of autonomy</measure>
    <time_frame>It will be evaluated at time = 0 for each patient</time_frame>
    <description>The primary outcome used to differentiate patients with Alzheimer's disease in pre-demented control subjects is the evaluation score of autonomy calculated from data collected during the execution of step semi directed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>analyze differences between inter-group patients</measure>
    <time_frame>It will be evaluated at time = 0 for each patient</time_frame>
    <description>The impact of behavioral problems in activities of daily living will be evaluated using the same criteria for evaluating the main objective analysis by an international group in a category between subjects diagnosed patients apathetic and not apathetic. Actigraphy data, recorded from the ecological assessment in experiment room until the end of the final medical examination, will quantify and qualify the motor activity of the subject at its presence on the premises of CMRR to compare these measures during the evaluation phases in experiment room, consulting and outside these two periods.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Predemential Alzheimer Patient</condition>
  <condition>Demential Alzheimer Patient</condition>
  <condition>Witness</condition>
  <arm_group>
    <arm_group_label>Control subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control subjects were people with memory complaints coming for a consultation and prevention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Predementia / MCI patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects at predementia stage or MCI stage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dementia patient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects at demential stage</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observationnal</intervention_name>
    <description>Observation during a physical exercise</description>
    <arm_group_label>Control subjects</arm_group_label>
    <arm_group_label>Dementia patient</arm_group_label>
    <arm_group_label>Predementia / MCI patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Subjects control Inclusion criteria&#xD;
&#xD;
          -  Male or Female ≥ 65 years&#xD;
&#xD;
          -  Subjects were not accompanied by an Alzheimer subject recruited for the study;&#xD;
&#xD;
          -  Subjects showing no locomotor disability;&#xD;
&#xD;
          -  Subjects with no cognitive impairment overall with a score&gt; 27 on the MMSE.&#xD;
&#xD;
        Special cases:&#xD;
&#xD;
        people with no schooling aged 50 to 79 years we take a MMSE&gt; 22/30 and for over 80 years a&#xD;
        MMSE&gt; 21/30 - by the standards of Kalafat, 2003) (Folstein, Folstein et al. 1975), or&#xD;
        arguments in favor of the following diagnosis: probable Alzheimer's disease according to&#xD;
        the criteria of the NINCDS-ADRDA and / or major depressive episode according to DSM-IV-R;&#xD;
&#xD;
          -  Subjects receiving a social security system;&#xD;
&#xD;
          -  Signature of informed consent.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Failure to perform the protocol due to a mobility impairment;&#xD;
&#xD;
          -  Prescription of a new psychotropic medication (hypnotic, anxiolytic, antidepressant,&#xD;
             antipsychotic) in the week preceding the assessment;&#xD;
&#xD;
          -  Patients implanted with a pacemaker;&#xD;
&#xD;
          -  Patient Trust under curatorship or judicial protection;&#xD;
&#xD;
          -  Detainees (administrative or judicial).&#xD;
&#xD;
        Predementia / MCI Patients Inclusion criteria&#xD;
&#xD;
          -  Men or women ≥ 65 years.&#xD;
&#xD;
          -  Subjects with a diagnosis of MCI according to the criteria of the National Institute&#xD;
             on Ageing and Alzheimer's Association group (Albert MS, 2011, see Appendix B), or&#xD;
             Alzheimer's disease stage prédementiel (B. Dubois, 2010; see Appendix C)&#xD;
&#xD;
          -  Subjects with a score of 0 to items of &quot;tremors&quot; and &quot;muscle stiffness&quot; of the UPDRS&#xD;
             III&#xD;
&#xD;
          -  Subjects with no criteria for major depressive episode according to DSM IV-R;&#xD;
&#xD;
          -  Subjects receiving a social security system;&#xD;
&#xD;
          -  Signature of informed consent. Exclusion Criteria&#xD;
&#xD;
          -  Failure to pass neuropsychological testing because of a sensory or motor deficit;&#xD;
&#xD;
          -  Prescription of a new psychotropic medication (hypnotic, anxiolytic, antidepressant,&#xD;
             antipsychotic) in the week preceding the assessment;&#xD;
&#xD;
          -  Patients implanted with a pacemaker;&#xD;
&#xD;
          -  Patient Trust under curatorship or judicial protection.&#xD;
&#xD;
        dementia subjects Inclusion criteria&#xD;
&#xD;
          -  Men and women older than 65 years&#xD;
&#xD;
          -  Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann,&#xD;
             Drachman et al. 1984) or Alzheimer's typical or atypical (B. Dubois et al. 2007)&#xD;
&#xD;
          -  MMSE score ≥ 16&#xD;
&#xD;
          -  Subjects with a score of 0 to items of &quot;tremors&quot; and &quot;muscle stiffness&quot; of the UPDRS&#xD;
             III&#xD;
&#xD;
          -  Subjects with no criteria for major depressive episode according to DSM IV-R;&#xD;
&#xD;
          -  Subjects receiving drug treatment by acetylcholinesterase inhibitor or memantine in&#xD;
             standard dose and stable for at least 3 months;&#xD;
&#xD;
          -  Subjects receiving a social security system;&#xD;
&#xD;
          -  Signature of informed consent.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Failure to pass neuropsychological testing because of a sensory or motor deficit;&#xD;
&#xD;
          -  Prescription of psychotropic medication (hypnotic, anxiolytic, antidepressant,&#xD;
             antipsychotic) in the week preceding the assessment;&#xD;
&#xD;
          -  Patients implanted with a pacemaker&#xD;
&#xD;
          -  Patient Trust under curatorship or judicial protection.&#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>Philippe ROBERT, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vanina OLIVERI, ARC</last_name>
    <email>oliveri.v@chu-nice.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Nice- Hôpital Cimiez_ CMRR</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe ROBERT, PU-PH</last_name>
    </contact>
    <contact_backup>
      <last_name>Guillaume SACCO, PH</last_name>
    </contact_backup>
    <investigator>
      <last_name>Philippe ROBERT, PU-PH</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guillaume SACCO, PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Renaud DAVID, PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>March 21, 2016</last_update_submitted>
  <last_update_submitted_qc>March 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01661660
org study id: 12-PP-01
nct id: NCT01661660
lead sponsor: 
has dmc: No
Cognitive symptoms are the core feature of Alzheimer's disease. Besides these problems,
      behavioural and psychological symptoms (BPSD), and an impairment of activities of daily
      living (IADL) are frequently encountered and usually show an impact on autonomy maintenance,
      prognostic and care during the prodromal and early stages of the disease.

      Such symptoms are noticeable before the diagnosis of dementia and their occurrences as well
      as their intensity increase with the evolution of the disease.

      Apathy, initially defined as a reduction of motivated behaviours, is the most frequently
      observed BPSD. Apathy is clinically defined by a significant reduction or complete loss of
      interest, initiative capacity and emotional blunting. Accordingly, apathy is characterized by
      diminished goal-directed cognitions and behaviours.

      Behavioural and psychological assessment relies essentially on neuropsychiatric scales. These
      are used to gather precise data regarding patient's clinical state from interviews with the
      patient, the career or from clinical impressions during the consultation. From their apparent
      simplicity they have made their way into daily clinical practices, yet neuropsychiatric
      scales are reportedly biased by the assessors' subjectivity.

      However, some tools whose allow simple, fast and objectively valid assessments are not widely
      used.

      Hence, the use of ICT such as actigraphy (wearable device assessing locomotion activities),
      automatized audio-video recognition and signal analysis from events, may be of interest in
      addition to current assessment methods.

      The aim of this study is to implement an objective assessment of goal directed activities and
      autonomy in an experimental design including predefined actions. The setting includes video
      cameras, microphones, actigraphic and Galvanic Skin Response sensors for recording and
      computer-based recognition of events using audio-video data, locomotion data and sinusal
      variability respectively as well as extracting biomarkers for supporting detection of
      dementia at early stages and supporting ongoing tracking of the dementia disease state. The
      following population will be included: patients with Mild Cognitive Impairment (n=50),
      patients with Alzheimer's disease (n=50) and control participants (n=50).

      This work will provide further objective information for clinical practitioner in order to
      detect behavioral disturbances such as apathy.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: the evaluation score of autonomy
time frame: It will be evaluated at time = 0 for each patient
description: The primary outcome used to differentiate patients with Alzheimer's disease in pre-demented control subjects is the evaluation score of autonomy calculated from data collected during the execution of step semi directed
measure: analyze differences between inter-group patients
time frame: It will be evaluated at time = 0 for each patient
description: The impact of behavioral problems in activities of daily living will be evaluated using the same criteria for evaluating the main objective analysis by an international group in a category between subjects diagnosed patients apathetic and not apathetic. Actigraphy data, recorded from the ecological assessment in experiment room until the end of the final medical examination, will quantify and qualify the motor activity of the subject at its presence on the premises of CMRR to compare these measures during the evaluation phases in experiment room, consulting and outside these two periods.
arm group label: Control subjects
arm group type: Active Comparator
description: Control subjects were people with memory complaints coming for a consultation and prevention.
arm group label: Predementia / MCI patients
arm group type: Experimental
description: Subjects at predementia stage or MCI stage
arm group label: Dementia patient
arm group type: Experimental
description: Subjects at demential stage
intervention type: Other
intervention name: observationnal
description: Observation during a physical exercise
arm group label: Control subjects
arm group label: Dementia patient
arm group label: Predementia / MCI patients
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe ROBERT, PU-PH
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nice
last name: Vanina OLIVERI, ARC
email: oliveri.v@chu-nice.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor