<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/NCT02208193</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00139-38</org_study_id>
    <nct_id>NCT02208193</nct_id>
  </id_info>
  <brief_title>Alzheimer's Disease, Art and Garden</brief_title>
  <acronym>JAZ ART</acronym>
  <official_title>Alzheimer's Disease and Healing Gardens: Study of the Cognitive and Psycho-behavioral Effects of an Artistic Dimension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gardens and art represent public spaces and support venues of interactions and emotions,&#xD;
      seeking not only a variety of conversational themes but also various cognitive skills such as&#xD;
      mnemonic skills. The cognitive and psycho-behavioral effects of art and the garden, jointly&#xD;
      associated and made available to patients suffering from Alzheimer's disease, need to be&#xD;
      evaluated.&#xD;
&#xD;
      MAIN OBJECTIVE Delineate the psychological scaffolding virtues of art and garden on cognitive&#xD;
      and emotional processes by means of interview analyses in Alzheimer patients and control&#xD;
      subjects based on the &quot; art, memory and life &quot; garden.&#xD;
&#xD;
      SECONDARY OBJECTIVES Adapt eco-psychosocial approaches of care management to Alzheimer&#xD;
      patients:&#xD;
&#xD;
        -  create assessment methods of:&#xD;
&#xD;
        -  the therapeutic efficacy of the design of the &quot; art, memory and life &quot; garden,&#xD;
&#xD;
        -  the perception of an artistic dimension in the living environment of those with&#xD;
           Alzheimer's disease,&#xD;
&#xD;
        -  establish:&#xD;
&#xD;
        -  workshop applications using art and the garden for therapeutic purposes,&#xD;
&#xD;
        -  general recommendations for the layout of the garden. PRIMARY ENDPOINT Quantitative data&#xD;
           of discursive productions stemming from Interlocutory Logic (Trognon and Batt, 2007,&#xD;
           2010, 2011) for the analysis of interactive behaviors and the assessment of parameters&#xD;
           including esthetic appraisals, well-being, mnemonic and emotional processes (frequency&#xD;
           and nature of these processes) as well as spatio-temporal orientation.&#xD;
&#xD;
      SECONDARY ENDPOINTS&#xD;
&#xD;
        -  Scores obtained in standard neuropsychological tests, in particular to assess&#xD;
           spatio-temporal orientation (Folstein MMSE),&#xD;
&#xD;
        -  Scores obtained with the &quot; MemoArtZ &quot; tool (MAZ) to evaluate the memorization of&#xD;
           artistic elements of the garden,&#xD;
&#xD;
        -  Scores from the &quot; General Esthetic Preference &quot; (GEP) tool to evaluate the consistency&#xD;
           of general esthetic appreciations,&#xD;
&#xD;
        -  Score obtained with the specific mood assessment scale (CSDD) for subjects in group A,&#xD;
&#xD;
        -  Score obtained with the specific assessment of emotional events scale (AES) for all&#xD;
           subjects.&#xD;
&#xD;
      RESEARCH METHODOLOGY&#xD;
&#xD;
      Open, monocentric, controlled (group of healthy control subjects) study.&#xD;
&#xD;
      Population: 2 groups:&#xD;
&#xD;
      Group A &quot;Alzheimer group&quot;: patients with mild to severe stages of Alzheimer's disease:&#xD;
      subgroup A1 &quot;Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul&#xD;
      Spillmann, CPS)&quot; (CHU de Nancy, France); subgroup A2 &quot;Alzheimer group monitored at the&#xD;
      Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)&quot;&#xD;
      (CHU de Nancy, France) Group B &quot;healthy control group&quot;: healthy volunteers&#xD;
&#xD;
      Therapeutic fallouts of this study will benefit Alzheimer patients in terms of better care&#xD;
      management, notably: i) by determining the design, conception and layout of the gardens&#xD;
      destined to these patients, ii) by developing the introduction of an artistic dimension to&#xD;
      the design of such healing gardens and in their living environment, iii) by establishing&#xD;
      workshop application perspectives using the contemplation of works of art and the garden for&#xD;
      therapeutic purposes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RESEARCH METHODOLOGY / EXPERIMENTAL DESIGN&#xD;
&#xD;
      Open, monocentric, controlled (group of healthy control subjects) study.&#xD;
&#xD;
      Population: 2 groups:&#xD;
&#xD;
      Group A &quot;Alzheimer group&quot;: patients with mild to severe stages of Alzheimer's disease:&#xD;
      subgroup A1 &quot;Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul&#xD;
      Spillmann, CPS)&quot; (CHU de Nancy, France); subgroup A2 &quot;Alzheimer group monitored at the&#xD;
      Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)&quot;&#xD;
      (CHU de Nancy, France) Group B &quot;healthy control group&quot;: healthy volunteers&#xD;
&#xD;
      SPECIFIC ASSESSMENT PROCEDURES&#xD;
&#xD;
      TASKS SPECIFIC TO THE STUDY: MATERIALS&#xD;
&#xD;
      Interview methodology: The interrelationships between garden, art, cognition and behavior&#xD;
      will be assessed. The endpoints of these dimensions will be achieved by an analysis of&#xD;
      subject-psychologist interactions via interviews in the garden (in-context) and in&#xD;
      out-of-context mnemonic interviews. These interviews will be recorded and transcribed&#xD;
      verbatim. The interest of juxtaposing these two interview situations, in a comparative&#xD;
      analysis of interactional production, is to be able to access different cognitive skills in&#xD;
      order to analyze these skills. All of the data will be extracted through the quantitative&#xD;
      analysis of discursive productions stemming from Interlocutory Logic (Trognon and Batt, 2007,&#xD;
      2010, 2011). The investigators analyses will consist, on the one hand, of exploring the&#xD;
      public production of private thoughts of the subject (cognition and emotions) and secondly,&#xD;
      to modelize interactive behaviors. The interlocutory space will be both referential and&#xD;
      modal. All in all, the investigators will observe and analyze the eventual discursive&#xD;
      productions of the subject in reference to the &quot;art, memory and life&quot; garden, whether they&#xD;
      are related to the subject's experiences in the garden (in-context), to the narrative&#xD;
      situation in recounting his or her experience in the garden (out-of-context) or to the&#xD;
      spontaneous use of the garden for subjects in group A1. The implemented approach will have a&#xD;
      strong ecological perspective.&#xD;
&#xD;
      Interlocutory logic is an analysis method developed in the INTERPSY laboratory . This&#xD;
      pragmatic-dialogic method analyzes discourse in situations of interaction. This analytical&#xD;
      process is aimed at expliciting the basic components of communication, interlocutory&#xD;
      management and socio-cognitive-discursive events occurring in conversations.&#xD;
&#xD;
      For subjects in Group A:&#xD;
&#xD;
      Mood assessment: Cornell Scale for Depression in Dementia (CSDD, Cornell, 1988), translated&#xD;
      into French.&#xD;
&#xD;
      For subjects in Group A and in Group B&#xD;
&#xD;
        -  Assessment of emotional events: Apathy Scale: Marin's Apathy Evaluation Scale (AES)&#xD;
&#xD;
        -  Questionnaire on artistic and cultural activities (ACA) pertaining to all artistic and&#xD;
           cultural activities that the subject appreciates and/or is engaged in or has engaged in.&#xD;
&#xD;
        -  Assessment of general esthetic preferences: &quot;General Esthetic Preference&quot; (GEP) tool&#xD;
&#xD;
        -  Designed along the lines of those used by Kawabata and Zeki and by Halpern et al. for&#xD;
           their respective studies (Kawabata and Zeki, 2010; Halpern et al., 2008).&#xD;
&#xD;
        -  Materials: photographs representing works of art - paintings and sculptures - belonging&#xD;
           to three styles: figurative, stylized or abstract, each representing categories - living&#xD;
           or non-living.&#xD;
&#xD;
        -  Task to be performed by the subject: for each photograph presented, the subject's task&#xD;
           is to express an esthetic judgment using a visual analogue scale. After collecting the&#xD;
           subject's esthetic judgment, his or her esthetic emotions will be assessed through two&#xD;
           propositional questions.&#xD;
&#xD;
        -  Objective: Document the feelings relative to the person's preference for a certain&#xD;
           artistic style.&#xD;
&#xD;
      Interview-discovery and interview-knowledge of the garden (in-context) (30 min per&#xD;
      interview): During the walk-through, the subject, accompanied by the psychologist, will&#xD;
      observe the entire garden and its artistic elements. The subject will be queried through a&#xD;
      discussion aimed at promoting the expressing of immediate reactions on the artistic&#xD;
      dimensions. The analytical approach will enable to assess:&#xD;
&#xD;
        -  the esthetic preferences of the artistic elements integrated in the garden&#xD;
&#xD;
        -  the mnemonic and emotional processes (nature and frequency) that are mobilized during&#xD;
           the contemplation of the elements of the garden, whether vegetation or artistic.&#xD;
&#xD;
        -  the expressions of well-being and curiosity prompted by the works of art&#xD;
&#xD;
        -  the mnemonic processes referring to temporality and space&#xD;
&#xD;
      Out-of-context assessments (90 min per assessment):&#xD;
&#xD;
        -  Mnemonic interview (about 30 min): in a closed office blinded to the outside, the&#xD;
           psychologist invites the subject to recall what he or she has experienced in the garden.&#xD;
           In other words, the subject is asked to narrate an experience outside of its context. In&#xD;
           this situation, the context must be formalized verbally which leads to the mobilization&#xD;
           of cognitive skills other than those mobilized in the first in-context situation.&#xD;
&#xD;
        -  General esthetic preferences (GEP tool): This assessment will reveal the perseverance&#xD;
           for certain esthetic preferences or, conversely, the detachment relative to certain&#xD;
           styles or categories addressed prior to the first walk in the garden.&#xD;
&#xD;
        -  Mnemonic aspects of artistic elements &quot; MémoArtZ &quot; (MAZ) tool:&#xD;
&#xD;
        -  Task to be performed by the subject: view photographs representing the various works of&#xD;
           art discovered in the garden, inserted amidst distractive elements.&#xD;
&#xD;
        -  Instructions: &quot;Show me the photograph that represents an item you saw in the garden&quot;.&#xD;
&#xD;
        -  Aim: the analysis will enable to objectify potential encoded memory recalls referring to&#xD;
           the artistic elements of the garden.&#xD;
&#xD;
        -  The mnemonic processes regarding temporality and space will also be brought to light&#xD;
           through exchanges initiated by open questions, particularly around the theme of the&#xD;
           current season of the year. The investigators will observe whether the fact of having&#xD;
           been in the garden allows the subject to change and readjust his or her eventually&#xD;
           inadequate response given at the MMSE (context aid).&#xD;
&#xD;
        -  Mood assessment (CSDD) for subjects in group A only&#xD;
&#xD;
        -  Assessment of emotional events (AES) for subjects in groups A and B.&#xD;
&#xD;
      ASSESSMENT SCHEDULE SPECIFIC TO THE RESEARCH&#xD;
&#xD;
      Group A &quot; Alzheimer Group &quot;&#xD;
&#xD;
      Subgroup A1 &quot; Alzheimer group hospitalized at the Paul Spillmann Centre &quot;&#xD;
&#xD;
      Inclusion visit With the investigator/physician&#xD;
&#xD;
        -  Explanation of the objective and conduct of the research&#xD;
&#xD;
        -  Upon participation consent: provision of the information document and of the consent&#xD;
           form and signing of the latter&#xD;
&#xD;
        -  Informing of the trusted person or primary caregiver (with provision of an information&#xD;
           document)&#xD;
&#xD;
        -  If patient consent: Informing of the attending physician&#xD;
&#xD;
        -  Validation of inclusion and non-inclusion criteria&#xD;
&#xD;
      With the psychologist: T0:&#xD;
&#xD;
        -  CSDD and AES scales&#xD;
&#xD;
        -  ACA questionnaire&#xD;
&#xD;
        -  GEP assessment&#xD;
&#xD;
      Visit 1 (as soon as possible after the inclusion visit)&#xD;
&#xD;
      Takes place in 2 stages on the same day:&#xD;
&#xD;
        -  T1: Interview-discovery of the garden (in-context)&#xD;
&#xD;
        -  T1+: Out-of-context assessment (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)&#xD;
&#xD;
      Spontaneous use of the garden&#xD;
&#xD;
      Visit 2 (after a three-day period of spontaneous use of the garden, consecutive or not, or&#xD;
      from the 4th day onward within a maximum delay of 10 days after visit 1)&#xD;
&#xD;
        -  T2: Interview-knowledge of the garden (in-context)&#xD;
&#xD;
        -  T2+: out-of-context interview (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)&#xD;
&#xD;
      Subgroup A2 &quot;Alzheimer group monitored at the Resource and Research Memory Centre (CMRR) &quot;&#xD;
&#xD;
      At the CMRR with the investigator/physician:&#xD;
&#xD;
        -  Verification of inclusion and non-inclusion criteria in light of medical records&#xD;
&#xD;
        -  Upon participation consent: provision of the information document and the consent form&#xD;
&#xD;
        -  Informing of the trusted person or primary caregiver (with provision of an information&#xD;
           document)&#xD;
&#xD;
        -  If patient consent: treating physician will be informed&#xD;
&#xD;
        -  Scheduling of an appointment at the CPS&#xD;
&#xD;
      Visit 1 (over a single day, at the CPS)&#xD;
&#xD;
      Inclusion work-up with the investigator/physician of the CPS:&#xD;
&#xD;
        -  Presentation of the study and careful reading of the information document&#xD;
&#xD;
        -  Upon participation consent: signing of the consent form&#xD;
&#xD;
        -  The person of trust or primary caregiver will be informed (an information document will&#xD;
           be delivered)&#xD;
&#xD;
        -  If patient consent: Informing of the attending physician&#xD;
&#xD;
        -  Validation of inclusion and non-inclusion criteria&#xD;
&#xD;
      With the psychologist:&#xD;
&#xD;
      - T0: CSDD and AES scales ACA questionnaire GEP assessment&#xD;
&#xD;
        -  T1: Interview-discovery of the garden (in-context)&#xD;
&#xD;
        -  T1+: Out-of-context assessment (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)&#xD;
&#xD;
      Visit 2 (without use of the garden) within a maximum delay of 10 days after visit 1&#xD;
&#xD;
        -  T2: Interview-knowledge of the garden (in-context)&#xD;
&#xD;
        -  T2+: out-of-context interview (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)&#xD;
&#xD;
      Group B: &quot; healthy control group &quot;&#xD;
&#xD;
      Visit 1 (over a single day, at the CPS)&#xD;
&#xD;
      With the investigator/physician: inclusion work-up:&#xD;
&#xD;
        -  Presentation of the study and careful reading of the information document&#xD;
&#xD;
        -  Upon participation consent: signing of the consent form&#xD;
&#xD;
        -  Validation of inclusion and non-inclusion criteria&#xD;
&#xD;
      With the psychologist:&#xD;
&#xD;
      -T0: Neuropsychological assessment (90 min): neuropsychological tests used in routine&#xD;
      clinical practice CSDD and AES scale ACA questionnaire GEP assessment&#xD;
&#xD;
        -  T1: Interview-discovery of the garden (in-context)&#xD;
&#xD;
        -  T1+: out-of-context assessment (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)&#xD;
&#xD;
      Visit 2 (without use of the garden) within a maximum delay of 10 days after visit 1&#xD;
&#xD;
        -  T2: Interview-knowledge of the garden (in-context)&#xD;
&#xD;
        -  T2+: out-of-context interview (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES) TOTAL&#xD;
           NUMBER OF PARTICIPANTS Taking into account situations leading to permanent study&#xD;
           discontinuations, 60 subjects will be included: 40 patients (group A) and 20 control&#xD;
           subjects (group B)&#xD;
&#xD;
      DURATION OF THE STUDY Duration of inclusion period: 3 years Duration of participation:&#xD;
      maximum 8 weeks for the patients (including the follow-up period); 11 days for control&#xD;
      subjects Total duration time: 38 months (including analysis period and presentation of data)&#xD;
&#xD;
      STATISTICAL ANALYSIS The descriptive analysis will be performed by computing frequencies for&#xD;
      categorical variables and mean and standard deviation or median and extreme values for&#xD;
      continuous variables. The analysis will include a comparison of the different time periods of&#xD;
      the study. Between-group comparison of frequencies (sick patients versus healthy subjects or&#xD;
      paired series at different study times) will be performed by a Fisher Chi2 test or McNemar&#xD;
      test, comparison of means by a nonparametric test or a paired t-test for paired series&#xD;
      according to the conditions of application of the tests. The alpha risk is set at 5% for all&#xD;
      analyses. An a posteriori power calculation will be performed retrospectively for all&#xD;
      statistical tests. The analysis will be carried out using the SAS version V9.3 software&#xD;
      package.&#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">September 2017</completion_date>
  <primary_completion_date type="Anticipated">October 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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparaison of the number of language acts in each category between AD and controls subjects</measure>
    <time_frame>visit2 ( 10 days maximum after visit 1)</time_frame>
    <description>Each interaction between a subject and the psychologist is distributed into a interlocutory analysis table (Trognon and Batt, 2010 ; Batt, Trognon, Rivasseau-Jonveaux, Vernant and Jonveaux, 2014) where each utterance is noticed by its speech turn and its speech act. The second consists of a force (for example, an assertive force, as when I was eight, I loved the garden my parents owned) and a propositional content (for example, a feeling in its episodic context). Propositional content will be described according to its stimulus (for example, a kind of flower growing in the garden, a sculpture put into some place, etc.), to the interaction where it is produced and, more crucially, to the level of memory (procedural/semantics/episodics) it involves. These are the variables that will be then compared in using usual statistics between paired AD and control subjects at visit 1 and 2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scores obtained in standard neuropsychological tests, in particular to assess spatio-temporal orientation (Folstein MMSE),</measure>
    <time_frame>visit2 ( 10 days maximum after visit 1)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores obtained with the &quot; MemoArtZ &quot; tool (MAZ) to evaluate the memorization of artistic elements of the garden,</measure>
    <time_frame>visit2 ( 10 days maximum after visit 1)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores from the &quot; General Esthetic Preference &quot; (GEP) tool to evaluate the consistency of general esthetic appreciations,</measure>
    <time_frame>visit2 ( 10 days maximum after visit 1)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>obtained with the specific mood assessment scale (CSDD) for subjects in group A</measure>
    <time_frame>visit2 ( 10 days maximum after visit1)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score obtained with the specific assessment of emotional events scale (AES) for all subjects.</measure>
    <time_frame>visit2 ( 10 days maximum after visit 1)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>healthy controls group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alzheimer subjects group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A &quot;Alzheimer group&quot;: patients with mild to severe stages of Alzheimer's disease: subgroup A1 &quot;Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul Spillmann, CPS)&quot; (CHU de Nancy, France); subgroup A2 &quot;Alzheimer group monitored at the Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)&quot; (CHU de Nancy, France)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive and psycho-behavioral effects of an artistic dimension</intervention_name>
    <arm_group_label>Alzheimer subjects group</arm_group_label>
    <arm_group_label>healthy controls group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 60 to 100 years&#xD;
&#xD;
          -  able to walk independently, that is to say without recourse to aid, whether human or&#xD;
             technical, except for a simple cane&#xD;
&#xD;
          -  have never been in the garden &quot; art, memory and life &quot; of the Paul Spillmann Centre&#xD;
&#xD;
          -  gave their written consent after receiving clear and intelligible written and oral&#xD;
             information&#xD;
&#xD;
          -  with a diagnosis of a probable mild to severe stage of Alzheimer's disease according&#xD;
             to NINCDS-ADRDA diagnostic criteria (McKhann et al., 1984) within the last 2 months&#xD;
             prior to inclusion&#xD;
&#xD;
          -  score less than or equal to 4 on the Hachinski Ischemic Scale (Hachinski et al., 1984)&#xD;
             within the last 2 months prior to inclusion&#xD;
&#xD;
          -  Folstein MMSE score between 7 and 24 inclusively within the last 2 months prior to&#xD;
             inclusion&#xD;
&#xD;
          -  score of 4, 5 or 6 on the Reisberg Global Deterioration Scale (Reisberg et al., 1982)&#xD;
             within a 2-month delay prior to inclusion&#xD;
&#xD;
          -  specific drug treatment for Alzheimer's disease, unchanged since at least 2 months&#xD;
             (cholinesterase inhibitor and memantine)&#xD;
&#xD;
          -  no change in psychotropic treatment within 48 hours prior to inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of insurance coverage&#xD;
&#xD;
          -  sensory deficit interfering with the designated tasks in the study&#xD;
&#xD;
          -  phasic disorders interfering with the designated tasks in the study&#xD;
&#xD;
          -  history of head trauma (with loss of consciousness)&#xD;
&#xD;
          -  chronic alcoholism&#xD;
&#xD;
          -  refusal or inability to obtain the informed written consent of the subject&#xD;
&#xD;
          -  persons subject to a legal protection order&#xD;
&#xD;
          -  severe depression: score &gt; 20 on the GDS (Geriatric Depression Scale) scale at&#xD;
             inclusion&#xD;
&#xD;
          -  other neurological or psychiatric disorders potentially affecting the assessment&#xD;
&#xD;
          -  current or planned participation to other research involving neuropsychological&#xD;
             evaluations and/or drug trial, up until the end of the current study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thérèse Rivasseau Jonveaux, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU NANCY</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thérèse Rivasseau Jonveaux, MD</last_name>
    <phone>+33(0)3 83 85 11 31</phone>
    <email>t.jonveaux@chu-nancy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Nancy</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thérèse Rivasseau Jonveaux, MD</last_name>
      <phone>+33(0)3 83 85 11 31</phone>
      <email>t.jonveaux@chu-nancy.fr</email>
    </contact>
    <investigator>
      <last_name>Therese Rivasseau Jonveaux, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Athanase Benetos, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alina Pop, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gabriel Malerba, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>July 29, 2015</last_update_submitted>
  <last_update_submitted_qc>July 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer disease Art Healing gardens Discourse analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer 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/NCT02208193
org study id: 2014-A00139-38
nct id: NCT02208193
lead sponsor: 
has dmc: No
Gardens and art represent public spaces and support venues of interactions and emotions,
      seeking not only a variety of conversational themes but also various cognitive skills such as
      mnemonic skills. The cognitive and psycho-behavioral effects of art and the garden, jointly
      associated and made available to patients suffering from Alzheimer's disease, need to be
      evaluated.

      MAIN OBJECTIVE Delineate the psychological scaffolding virtues of art and garden on cognitive
      and emotional processes by means of interview analyses in Alzheimer patients and control
      subjects based on the " art, memory and life " garden.

      SECONDARY OBJECTIVES Adapt eco-psychosocial approaches of care management to Alzheimer
      patients:

        -  create assessment methods of:

        -  the therapeutic efficacy of the design of the " art, memory and life " garden,

        -  the perception of an artistic dimension in the living environment of those with
           Alzheimer's disease,

        -  establish:

        -  workshop applications using art and the garden for therapeutic purposes,

        -  general recommendations for the layout of the garden. PRIMARY ENDPOINT Quantitative data
           of discursive productions stemming from Interlocutory Logic (Trognon and Batt, 2007,
           2010, 2011) for the analysis of interactive behaviors and the assessment of parameters
           including esthetic appraisals, well-being, mnemonic and emotional processes (frequency
           and nature of these processes) as well as spatio-temporal orientation.

      SECONDARY ENDPOINTS

        -  Scores obtained in standard neuropsychological tests, in particular to assess
           spatio-temporal orientation (Folstein MMSE),

        -  Scores obtained with the " MemoArtZ " tool (MAZ) to evaluate the memorization of
           artistic elements of the garden,

        -  Scores from the " General Esthetic Preference " (GEP) tool to evaluate the consistency
           of general esthetic appreciations,

        -  Score obtained with the specific mood assessment scale (CSDD) for subjects in group A,

        -  Score obtained with the specific assessment of emotional events scale (AES) for all
           subjects.

      RESEARCH METHODOLOGY

      Open, monocentric, controlled (group of healthy control subjects) study.

      Population: 2 groups:

      Group A "Alzheimer group": patients with mild to severe stages of Alzheimer's disease:
      subgroup A1 "Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul
      Spillmann, CPS)" (CHU de Nancy, France); subgroup A2 "Alzheimer group monitored at the
      Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)"
      (CHU de Nancy, France) Group B "healthy control group": healthy volunteers

      Therapeutic fallouts of this study will benefit Alzheimer patients in terms of better care
      management, notably: i) by determining the design, conception and layout of the gardens
      destined to these patients, ii) by developing the introduction of an artistic dimension to
      the design of such healing gardens and in their living environment, iii) by establishing
      workshop application perspectives using the contemplation of works of art and the garden for
      therapeutic purposes.
RESEARCH METHODOLOGY / EXPERIMENTAL DESIGN

      Open, monocentric, controlled (group of healthy control subjects) study.

      Population: 2 groups:

      Group A "Alzheimer group": patients with mild to severe stages of Alzheimer's disease:
      subgroup A1 "Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul
      Spillmann, CPS)" (CHU de Nancy, France); subgroup A2 "Alzheimer group monitored at the
      Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)"
      (CHU de Nancy, France) Group B "healthy control group": healthy volunteers

      SPECIFIC ASSESSMENT PROCEDURES

      TASKS SPECIFIC TO THE STUDY: MATERIALS

      Interview methodology: The interrelationships between garden, art, cognition and behavior
      will be assessed. The endpoints of these dimensions will be achieved by an analysis of
      subject-psychologist interactions via interviews in the garden (in-context) and in
      out-of-context mnemonic interviews. These interviews will be recorded and transcribed
      verbatim. The interest of juxtaposing these two interview situations, in a comparative
      analysis of interactional production, is to be able to access different cognitive skills in
      order to analyze these skills. All of the data will be extracted through the quantitative
      analysis of discursive productions stemming from Interlocutory Logic (Trognon and Batt, 2007,
      2010, 2011). The investigators analyses will consist, on the one hand, of exploring the
      public production of private thoughts of the subject (cognition and emotions) and secondly,
      to modelize interactive behaviors. The interlocutory space will be both referential and
      modal. All in all, the investigators will observe and analyze the eventual discursive
      productions of the subject in reference to the "art, memory and life" garden, whether they
      are related to the subject's experiences in the garden (in-context), to the narrative
      situation in recounting his or her experience in the garden (out-of-context) or to the
      spontaneous use of the garden for subjects in group A1. The implemented approach will have a
      strong ecological perspective.

      Interlocutory logic is an analysis method developed in the INTERPSY laboratory . This
      pragmatic-dialogic method analyzes discourse in situations of interaction. This analytical
      process is aimed at expliciting the basic components of communication, interlocutory
      management and socio-cognitive-discursive events occurring in conversations.

      For subjects in Group A:

      Mood assessment: Cornell Scale for Depression in Dementia (CSDD, Cornell, 1988), translated
      into French.

      For subjects in Group A and in Group B

        -  Assessment of emotional events: Apathy Scale: Marin's Apathy Evaluation Scale (AES)

        -  Questionnaire on artistic and cultural activities (ACA) pertaining to all artistic and
           cultural activities that the subject appreciates and/or is engaged in or has engaged in.

        -  Assessment of general esthetic preferences: "General Esthetic Preference" (GEP) tool

        -  Designed along the lines of those used by Kawabata and Zeki and by Halpern et al. for
           their respective studies (Kawabata and Zeki, 2010; Halpern et al., 2008).

        -  Materials: photographs representing works of art - paintings and sculptures - belonging
           to three styles: figurative, stylized or abstract, each representing categories - living
           or non-living.

        -  Task to be performed by the subject: for each photograph presented, the subject's task
           is to express an esthetic judgment using a visual analogue scale. After collecting the
           subject's esthetic judgment, his or her esthetic emotions will be assessed through two
           propositional questions.

        -  Objective: Document the feelings relative to the person's preference for a certain
           artistic style.

      Interview-discovery and interview-knowledge of the garden (in-context) (30 min per
      interview): During the walk-through, the subject, accompanied by the psychologist, will
      observe the entire garden and its artistic elements. The subject will be queried through a
      discussion aimed at promoting the expressing of immediate reactions on the artistic
      dimensions. The analytical approach will enable to assess:

        -  the esthetic preferences of the artistic elements integrated in the garden

        -  the mnemonic and emotional processes (nature and frequency) that are mobilized during
           the contemplation of the elements of the garden, whether vegetation or artistic.

        -  the expressions of well-being and curiosity prompted by the works of art

        -  the mnemonic processes referring to temporality and space

      Out-of-context assessments (90 min per assessment):

        -  Mnemonic interview (about 30 min): in a closed office blinded to the outside, the
           psychologist invites the subject to recall what he or she has experienced in the garden.
           In other words, the subject is asked to narrate an experience outside of its context. In
           this situation, the context must be formalized verbally which leads to the mobilization
           of cognitive skills other than those mobilized in the first in-context situation.

        -  General esthetic preferences (GEP tool): This assessment will reveal the perseverance
           for certain esthetic preferences or, conversely, the detachment relative to certain
           styles or categories addressed prior to the first walk in the garden.

        -  Mnemonic aspects of artistic elements " MémoArtZ " (MAZ) tool:

        -  Task to be performed by the subject: view photographs representing the various works of
           art discovered in the garden, inserted amidst distractive elements.

        -  Instructions: "Show me the photograph that represents an item you saw in the garden".

        -  Aim: the analysis will enable to objectify potential encoded memory recalls referring to
           the artistic elements of the garden.

        -  The mnemonic processes regarding temporality and space will also be brought to light
           through exchanges initiated by open questions, particularly around the theme of the
           current season of the year. The investigators will observe whether the fact of having
           been in the garden allows the subject to change and readjust his or her eventually
           inadequate response given at the MMSE (context aid).

        -  Mood assessment (CSDD) for subjects in group A only

        -  Assessment of emotional events (AES) for subjects in groups A and B.

      ASSESSMENT SCHEDULE SPECIFIC TO THE RESEARCH

      Group A " Alzheimer Group "

      Subgroup A1 " Alzheimer group hospitalized at the Paul Spillmann Centre "

      Inclusion visit With the investigator/physician

        -  Explanation of the objective and conduct of the research

        -  Upon participation consent: provision of the information document and of the consent
           form and signing of the latter

        -  Informing of the trusted person or primary caregiver (with provision of an information
           document)

        -  If patient consent: Informing of the attending physician

        -  Validation of inclusion and non-inclusion criteria

      With the psychologist: T0:

        -  CSDD and AES scales

        -  ACA questionnaire

        -  GEP assessment

      Visit 1 (as soon as possible after the inclusion visit)

      Takes place in 2 stages on the same day:

        -  T1: Interview-discovery of the garden (in-context)

        -  T1+: Out-of-context assessment (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)

      Spontaneous use of the garden

      Visit 2 (after a three-day period of spontaneous use of the garden, consecutive or not, or
      from the 4th day onward within a maximum delay of 10 days after visit 1)

        -  T2: Interview-knowledge of the garden (in-context)

        -  T2+: out-of-context interview (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)

      Subgroup A2 "Alzheimer group monitored at the Resource and Research Memory Centre (CMRR) "

      At the CMRR with the investigator/physician:

        -  Verification of inclusion and non-inclusion criteria in light of medical records

        -  Upon participation consent: provision of the information document and the consent form

        -  Informing of the trusted person or primary caregiver (with provision of an information
           document)

        -  If patient consent: treating physician will be informed

        -  Scheduling of an appointment at the CPS

      Visit 1 (over a single day, at the CPS)

      Inclusion work-up with the investigator/physician of the CPS:

        -  Presentation of the study and careful reading of the information document

        -  Upon participation consent: signing of the consent form

        -  The person of trust or primary caregiver will be informed (an information document will
           be delivered)

        -  If patient consent: Informing of the attending physician

        -  Validation of inclusion and non-inclusion criteria

      With the psychologist:

      - T0: CSDD and AES scales ACA questionnaire GEP assessment

        -  T1: Interview-discovery of the garden (in-context)

        -  T1+: Out-of-context assessment (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)

      Visit 2 (without use of the garden) within a maximum delay of 10 days after visit 1

        -  T2: Interview-knowledge of the garden (in-context)

        -  T2+: out-of-context interview (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)

      Group B: " healthy control group "

      Visit 1 (over a single day, at the CPS)

      With the investigator/physician: inclusion work-up:

        -  Presentation of the study and careful reading of the information document

        -  Upon participation consent: signing of the consent form

        -  Validation of inclusion and non-inclusion criteria

      With the psychologist:

      -T0: Neuropsychological assessment (90 min): neuropsychological tests used in routine
      clinical practice CSDD and AES scale ACA questionnaire GEP assessment

        -  T1: Interview-discovery of the garden (in-context)

        -  T1+: out-of-context assessment (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)

      Visit 2 (without use of the garden) within a maximum delay of 10 days after visit 1

        -  T2: Interview-knowledge of the garden (in-context)

        -  T2+: out-of-context interview (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES) TOTAL
           NUMBER OF PARTICIPANTS Taking into account situations leading to permanent study
           discontinuations, 60 subjects will be included: 40 patients (group A) and 20 control
           subjects (group B)

      DURATION OF THE STUDY Duration of inclusion period: 3 years Duration of participation:
      maximum 8 weeks for the patients (including the follow-up period); 11 days for control
      subjects Total duration time: 38 months (including analysis period and presentation of data)

      STATISTICAL ANALYSIS The descriptive analysis will be performed by computing frequencies for
      categorical variables and mean and standard deviation or median and extreme values for
      continuous variables. The analysis will include a comparison of the different time periods of
      the study. Between-group comparison of frequencies (sick patients versus healthy subjects or
      paired series at different study times) will be performed by a Fisher Chi2 test or McNemar
      test, comparison of means by a nonparametric test or a paired t-test for paired series
      according to the conditions of application of the tests. The alpha risk is set at 5% for all
      analyses. An a posteriori power calculation will be performed retrospectively for all
      statistical tests. The analysis will be carried out using the SAS version V9.3 software
      package.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Comparaison of the number of language acts in each category between AD and controls subjects
time frame: visit2 ( 10 days maximum after visit 1)
description: Each interaction between a subject and the psychologist is distributed into a interlocutory analysis table (Trognon and Batt, 2010 ; Batt, Trognon, Rivasseau-Jonveaux, Vernant and Jonveaux, 2014) where each utterance is noticed by its speech turn and its speech act. The second consists of a force (for example, an assertive force, as when I was eight, I loved the garden my parents owned) and a propositional content (for example, a feeling in its episodic context). Propositional content will be described according to its stimulus (for example, a kind of flower growing in the garden, a sculpture put into some place, etc.), to the interaction where it is produced and, more crucially, to the level of memory (procedural/semantics/episodics) it involves. These are the variables that will be then compared in using usual statistics between paired AD and control subjects at visit 1 and 2
measure: Scores obtained in standard neuropsychological tests, in particular to assess spatio-temporal orientation (Folstein MMSE),
time frame: visit2 ( 10 days maximum after visit 1)
measure: Scores obtained with the " MemoArtZ " tool (MAZ) to evaluate the memorization of artistic elements of the garden,
time frame: visit2 ( 10 days maximum after visit 1)
measure: Scores from the " General Esthetic Preference " (GEP) tool to evaluate the consistency of general esthetic appreciations,
time frame: visit2 ( 10 days maximum after visit 1)
measure: obtained with the specific mood assessment scale (CSDD) for subjects in group A
time frame: visit2 ( 10 days maximum after visit1)
measure: Score obtained with the specific assessment of emotional events scale (AES) for all subjects.
time frame: visit2 ( 10 days maximum after visit 1)
arm group label: healthy controls group
arm group type: Experimental
description: Healthy volunteers
arm group label: Alzheimer subjects group
arm group type: Experimental
description: Group A "Alzheimer group": patients with mild to severe stages of Alzheimer's disease: subgroup A1 "Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul Spillmann, CPS)" (CHU de Nancy, France); subgroup A2 "Alzheimer group monitored at the Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)" (CHU de Nancy, France)
intervention type: Behavioral
intervention name: Cognitive and psycho-behavioral effects of an artistic dimension
arm group label: Alzheimer subjects group
arm group label: healthy controls group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thérèse Rivasseau Jonveaux, MD
role: Principal Investigator
affiliation: CHU NANCY
last name: Thérèse Rivasseau Jonveaux, MD
phone: +33(0)3 83 85 11 31
email: t.jonveaux@chu-nancy.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Alzheimer Disease