<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/NCT01692977</url>
  </required_header>
  <id_info>
    <org_study_id>2011-A00993-38</org_study_id>
    <nct_id>NCT01692977</nct_id>
  </id_info>
  <brief_title>What Elements of the Design of a Healing Garden Are Used as Landmarks by Patients With Alzheimer's Disease to Locate?</brief_title>
  <acronym>JAZ-TOP</acronym>
  <official_title>Orienting Oneself in a Healing Garden: What Elements of the Design Are Used as Landmarks by Patients With Alzheimer's Disease ?</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>
      The disruption of spatial orientation is considered the second most common cognitive symptom&#xD;
      of dementia, affecting nearly all activities of daily living. Research in the field of&#xD;
      environmental psychology has helped to highlight the influence of the environment on patients&#xD;
      with Alzheimer's disease or related syndromes. With regard to spatial orientation, it has&#xD;
      been shown that an environment can provide support for cognitive failures in subjects if that&#xD;
      particular space is adapted. While numerous studies have focused on the architectural&#xD;
      environment (hospital, housing facility), none have explored the ability of patients to&#xD;
      orient themselves in a natural environment such as a garden. Yet, in recent years, such&#xD;
      gardens, known as healing gardens, have emerged in housing and care facilities, providing&#xD;
      genuine support for the care management of patients with Alzheimer-type dementia. Various&#xD;
      works have been published outlining recommendations for their management. However, with&#xD;
      regard to spatial orientation, none of the available research has explored the basic&#xD;
      principles on which to rely on in order to organize the elements of outdoor spaces into&#xD;
      itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence of&#xD;
      such data, these authors recommend relying on five elements, identified by Lynch in his&#xD;
      landmark book &quot;Image of the City&quot; (1960), that people use to orient themselves and find their&#xD;
      way. These are &quot; paths &quot;, &quot; edges &quot;, &quot; districts &quot;, &quot; nodes &quot; and &quot; landmarks &quot;. The&#xD;
      hypothesis to verify is that patients with Alzheimer's disease do not rely on the same&#xD;
      elements of the garden as non-Alzheimer's subjects in making orientation decisions and to&#xD;
      mentally picture this environment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analyze nature and frequency of elements of the &quot; art, memory and life &quot; garden used as landmarks by Alzheimer's disease patients</measure>
    <time_frame>Baseline = inclusion visit</time_frame>
    <description>To describe and compare nature and frequency of elements involved in orientation decisions and the cognitive map, between a group of subjects with Alzheimer's disease and a group of healthy control subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.</measure>
    <time_frame>Baseline = inclusion visit</time_frame>
    <description>To identify, through analysis of interviews based on problem solving and interlocutory logic (TROGNON and BATT, 2007,2010, 2011), the characteristics of the elements of the &quot; art, memory and life &quot; garden that contributed to decision-making regarding spatial orientation and the development of a mental representation of the garden, in patients with Alzheimer's disease and healthy elderly subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.</measure>
    <time_frame>Baseline = inclusion visit</time_frame>
    <description>To study the correlation between the degree of success in experimental tasks (route learning, cognitive map) and standard and specific neuropsychological assessment (visuospatial skills) of individuals with Alzheimer's disease and healthy control subjects.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Alzheimer disease patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alzheimer disease patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>healthy control subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>neuropsychological assessment</intervention_name>
    <arm_group_label>Alzheimer disease patients</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All subjects (groups A and B):&#xD;
&#xD;
          -  able to walk autonomously, that is without help, whether human or technical, except&#xD;
             for a walking cane&#xD;
&#xD;
          -  are aged 65 to 90 years&#xD;
&#xD;
          -  have never been in the &quot;art, memory and life&quot; garden at the Paul SPILLMANN Centre&#xD;
             prior to the study&#xD;
&#xD;
          -  have given their written consent after receiving clear and intelligible oral and&#xD;
             written information.&#xD;
&#xD;
        Group A : patients with Alzheimer's disease:&#xD;
&#xD;
          -  diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA diagnostic&#xD;
             criteria (Mc KHANN et al., 1984)&#xD;
&#xD;
          -  score less than or equal to 4 on the Hachinski ischemic scale (Hachinski et al., 1984)&#xD;
&#xD;
          -  Folstein MMSE score between 10 and 24 inclusively&#xD;
&#xD;
          -  score equal to 5 or 6 on the Reisberg Global Deterioration Scale (REISBERG et al.,&#xD;
             1982).&#xD;
&#xD;
          -  stable, specific treatment of Alzheimer's disease (cholinesterase and memantine)&#xD;
&#xD;
          -  taking of psychotropic drugs authorized, but no change in treatment during at least&#xD;
             the last 48 hours&#xD;
&#xD;
        Group B: healthy control subjects:&#xD;
&#xD;
          -  absence of dementia according to NINCDS-ADRDA criteria (Mc KHANN et al., 1984)&#xD;
&#xD;
          -  normal performance on Folstein MMSE, according to the GRECO (en français : Groupe de&#xD;
             REflexions sur les Evaluations Cognitives) standards (Reflection Group on Cognitive&#xD;
             Assessments)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For all subjects (groups A and B):&#xD;
&#xD;
          -  Absence of social security coverage&#xD;
&#xD;
          -  sensory deficit interfering with the task&#xD;
&#xD;
          -  aphasia interfering with the task&#xD;
&#xD;
          -  history of head trauma (with loss of consciousness)&#xD;
&#xD;
          -  chronic alcoholism&#xD;
&#xD;
          -  refusal or inability to obtain written informed consent form from the patient&#xD;
&#xD;
          -  legally protected person&#xD;
&#xD;
          -  severe depression: score higher than 20 on the 30-item Geriatric Depression Scale&#xD;
             (GDS)&#xD;
&#xD;
        Group A : patients with Alzheimer's disease:&#xD;
&#xD;
          -  other neurological or psychiatric diseases that may affect the assessment Group B:&#xD;
             healthy control subjects&#xD;
&#xD;
          -  neurological or psychiatric diseases that may affect the assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thérèse Rivasseau Jonveaux, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Nancy, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Nancy , Saint Julien Hospital, France</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</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>
  <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/NCT01692977
org study id: 2011-A00993-38
nct id: NCT01692977
lead sponsor: 
has dmc: No
The disruption of spatial orientation is considered the second most common cognitive symptom
      of dementia, affecting nearly all activities of daily living. Research in the field of
      environmental psychology has helped to highlight the influence of the environment on patients
      with Alzheimer's disease or related syndromes. With regard to spatial orientation, it has
      been shown that an environment can provide support for cognitive failures in subjects if that
      particular space is adapted. While numerous studies have focused on the architectural
      environment (hospital, housing facility), none have explored the ability of patients to
      orient themselves in a natural environment such as a garden. Yet, in recent years, such
      gardens, known as healing gardens, have emerged in housing and care facilities, providing
      genuine support for the care management of patients with Alzheimer-type dementia. Various
      works have been published outlining recommendations for their management. However, with
      regard to spatial orientation, none of the available research has explored the basic
      principles on which to rely on in order to organize the elements of outdoor spaces into
      itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence of
      such data, these authors recommend relying on five elements, identified by Lynch in his
      landmark book "Image of the City" (1960), that people use to orient themselves and find their
      way. These are " paths ", " edges ", " districts ", " nodes " and " landmarks ". The
      hypothesis to verify is that patients with Alzheimer's disease do not rely on the same
      elements of the garden as non-Alzheimer's subjects in making orientation decisions and to
      mentally picture this environment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Analyze nature and frequency of elements of the " art, memory and life " garden used as landmarks by Alzheimer's disease patients
time frame: Baseline = inclusion visit
description: To describe and compare nature and frequency of elements involved in orientation decisions and the cognitive map, between a group of subjects with Alzheimer's disease and a group of healthy control subjects.
measure: Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.
time frame: Baseline = inclusion visit
description: To identify, through analysis of interviews based on problem solving and interlocutory logic (TROGNON and BATT, 2007,2010, 2011), the characteristics of the elements of the " art, memory and life " garden that contributed to decision-making regarding spatial orientation and the development of a mental representation of the garden, in patients with Alzheimer's disease and healthy elderly subjects.
measure: Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.
time frame: Baseline = inclusion visit
description: To study the correlation between the degree of success in experimental tasks (route learning, cognitive map) and standard and specific neuropsychological assessment (visuospatial skills) of individuals with Alzheimer's disease and healthy control subjects.
arm group label: Alzheimer disease patients
arm group type: Experimental
description: Alzheimer disease patients
arm group label: control
arm group type: Active Comparator
description: healthy control subjects.
intervention type: Other
intervention name: neuropsychological assessment
arm group label: Alzheimer disease patients
arm group label: control
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thérèse Rivasseau Jonveaux, PhD
role: Principal Investigator
affiliation: University Hospital of Nancy, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Alzheimer Disease