<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/NCT03246269</url>
  </required_header>
  <id_info>
    <org_study_id>MoCA-Norm</org_study_id>
    <nct_id>NCT03246269</nct_id>
  </id_info>
  <brief_title>Normative Values for the German Version of the Montreal Cognitive Assessment (MoCA)</brief_title>
  <acronym>MoCA-Norm</acronym>
  <official_title>Normative Values for the German Version of the Montreal Cognitive Assessment (MoCA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andreas Monsch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational cohort study in healthy volunteers establishes normative data for the&#xD;
      German version of the Montreal Cognitive Assessment (MoCA) and investigates the possible&#xD;
      impacts of demographics on the MoCA total score.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Montreal Cognitive Assessment (MoCA) is a short tool to evaluate a multitude of cognitive&#xD;
      domains (visuospatial / executive functioning, object naming, memory, attention, language,&#xD;
      abstraction, orientation). The original English MoCA consistently showed very high&#xD;
      sensitivity and specificity in distinguishing patients with mild cognitive impairment from&#xD;
      healthy controls. Therefore it is an excellent tool for early recognition of cognitive&#xD;
      disorders. Based on a Canadian sample, the MoCA proposes a cut-off-value of 26/30 points.&#xD;
      However, there is increasing evidence of intercultural differences in terms of the best&#xD;
      cut-off-score. In addition the original version only slightly corrects for possible&#xD;
      influences of education - an adjustment for age- or gender-related effects is missing.&#xD;
      Therefore, the aim of our study was to investigate the possible impacts of demographics on&#xD;
      the MoCA total score and to provide normative values for a German-speaking population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA) - German version</measure>
    <time_frame>Baseline</time_frame>
    <description>Total score of the MoCA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examination (MMSE)</measure>
    <time_frame>Baseline</time_frame>
    <description>Total score of the MMSE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale (GDS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Total score of the GDS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)</measure>
    <time_frame>Baseline</time_frame>
    <description>Total score of the CERAD-NAB</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">334</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Cognitive Decline</condition>
  <condition>Cognition Disorders</condition>
  <condition>Cognitive Symptom</condition>
  <condition>Cognitive Change</condition>
  <condition>Cognitive Deterioration</condition>
  <condition>Cognitive Abnormality</condition>
  <condition>Cognitive Impairment, Mild</condition>
  <condition>Cognition Disorders in Old Age</condition>
  <condition>Dementia</condition>
  <condition>Dementia Alzheimers</condition>
  <condition>Dementia, Alzheimer Type</condition>
  <condition>Dementia, Mild</condition>
  <condition>Dementia of Alzheimer Type</condition>
  <arm_group>
    <arm_group_label>MoCA cohort</arm_group_label>
    <description>The German MoCA is administered once to all study participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MoCA</intervention_name>
    <arm_group_label>MoCA cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥65 years&#xD;
&#xD;
          -  Education ≥7 years&#xD;
&#xD;
          -  Fluency in the German language&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cognitive impairment&#xD;
&#xD;
          -  Depression&#xD;
&#xD;
          -  Severe sensory or motor impairment interfering with cognitive testing&#xD;
&#xD;
          -  Serious somatic disease&#xD;
&#xD;
          -  Disease or event affecting the central nervous system&#xD;
&#xD;
          -  Cerebrovascular disease&#xD;
&#xD;
          -  Regular medication with psychoactive drugs except for benzodiazepines&#xD;
&#xD;
          -  Participation in a cognitive study within the last 3 months&#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>Alessandra Thomann, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Felix Platter Hospital Basel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicolai Goettel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raphael Monsch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manfred Berres, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Applied Sciences Koblenz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andreas Monsch, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Felix Platter Hospital Basel</affiliation>
  </overall_official>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>May 30, 2018</last_update_submitted>
  <last_update_submitted_qc>May 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Basel, Switzerland</investigator_affiliation>
    <investigator_full_name>Andreas Monsch</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Neurobehavioral Manifestations</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Cognition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03246269
org study id: MoCA-Norm
nct id: NCT03246269
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational cohort study in healthy volunteers establishes normative data for the
      German version of the Montreal Cognitive Assessment (MoCA) and investigates the possible
      impacts of demographics on the MoCA total score.
The Montreal Cognitive Assessment (MoCA) is a short tool to evaluate a multitude of cognitive
      domains (visuospatial / executive functioning, object naming, memory, attention, language,
      abstraction, orientation). The original English MoCA consistently showed very high
      sensitivity and specificity in distinguishing patients with mild cognitive impairment from
      healthy controls. Therefore it is an excellent tool for early recognition of cognitive
      disorders. Based on a Canadian sample, the MoCA proposes a cut-off-value of 26/30 points.
      However, there is increasing evidence of intercultural differences in terms of the best
      cut-off-score. In addition the original version only slightly corrects for possible
      influences of education - an adjustment for age- or gender-related effects is missing.
      Therefore, the aim of our study was to investigate the possible impacts of demographics on
      the MoCA total score and to provide normative values for a German-speaking population.
observational model: Cohort
time perspective: Prospective
measure: Montreal Cognitive Assessment (MoCA) - German version
time frame: Baseline
description: Total score of the MoCA
measure: Mini-Mental State Examination (MMSE)
time frame: Baseline
description: Total score of the MMSE
measure: Geriatric Depression Scale (GDS)
time frame: Baseline
description: Total score of the GDS
measure: Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)
time frame: Baseline
description: Total score of the CERAD-NAB
arm group label: MoCA cohort
description: The German MoCA is administered once to all study participants.
intervention type: Diagnostic Test
intervention name: MoCA
arm group label: MoCA cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alessandra Thomann, MSc
role: Principal Investigator
affiliation: Felix Platter Hospital Basel
last name: Nicolai Goettel, MD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
last name: Raphael Monsch, MD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
last name: Manfred Berres, PhD
role: Principal Investigator
affiliation: University of Applied Sciences Koblenz
last name: Andreas Monsch, PhD
role: Study Chair
affiliation: Felix Platter Hospital Basel
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Basel, Switzerland
investigator full name: Andreas Monsch
investigator title: PhD
mesh term: Dementia
mesh term: Alzheimer Disease
mesh term: Neurobehavioral Manifestations
mesh term: Cognitive Dysfunction
mesh term: Cognition Disorders
sharing ipd: Undecided