<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/NCT03238001</url>
  </required_header>
  <id_info>
    <org_study_id>DCT032</org_study_id>
    <nct_id>NCT03238001</nct_id>
  </id_info>
  <brief_title>Evaluation of DCTclock™ as a Cognitive Assessment Aid</brief_title>
  <official_title>Evaluation of DCTclock™ as a Cognitive Assessment Aid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Digital Cognition Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Digital Cognition Technologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of this study is to demonstrate the safety and effectiveness of&#xD;
      DCTclock as an adjunctive tool for use by clinicians to evaluate cognitive function in adults&#xD;
      aged 55-95.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2017</start_date>
  <completion_date type="Actual">November 21, 2017</completion_date>
  <primary_completion_date type="Actual">November 21, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This study uses a paired design in which each subject undergoes blinded testing by separate testers administering DCTclock and a battery of reference standard tests to determine cognitive state.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)</measure>
    <time_frame>Visit 1 (day 1)</time_frame>
    <description>The primary analysis will assess agreement between DCTclock and the Montreal Cognitive Assessment (MoCA) and compare it to the agreement between the MMSE and MoCA at visit 1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quadratic Weighted Kappa on Primary Endpoints</measure>
    <time_frame>Visit 1 (day 1)</time_frame>
    <description>Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Agreement on Primary Endpoints</measure>
    <time_frame>Visit 1 (day 1)</time_frame>
    <description>Positive percent agreement, version A (treating the &quot;Indeterminate&quot; group as &quot;Unimpaired&quot;) and version B (removing the &quot;Indeterminate&quot; group from the analysis), and negative percent agreement version A and version B. These were calculated for the DCTclock/MoCA classification table as well as the MMSE/MoCA classification table. 95% CI were also calculated and compared between the two classification tables' calculations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regression Coefficients on Primary Endpoints</measure>
    <time_frame>Visit 1 (day 1)</time_frame>
    <description>Linear and rank-linear regression coefficients (slope, intercept) and 95% CI for DCTclock regressed on MoCA as well as for the MMSE regressed on MoCA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficients on Primary Endpoints</measure>
    <time_frame>Visit 1 (day 1)</time_frame>
    <description>Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)</measure>
    <time_frame>Visit 1 and visit 2, occurring 1-4 weeks apart</time_frame>
    <description>Quadratic weighted Cohen's Kappa statistics were calculated for both DCTclock and MMSE test-retest data (visit 1 vs visit 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Agreement on Secondary Endpoints (Test-retest Reliability)</measure>
    <time_frame>Visit 1 and visit 2, occurring 1-4 weeks apart</time_frame>
    <description>Positive percent agreement version A (treating the &quot;Indeterminate&quot; group as &quot;Unimpaired&quot;) and version B (removing the &quot;Indeterminate&quot; group from the analysis), negative percent agreement version A and version B, indeterminate percent agreement, and unimpaired percent agreement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regression Coefficients on Secondary Endpoints (Test-retest Reliability)</measure>
    <time_frame>Visit 1 and visit 2, occurring 1-4 weeks apart</time_frame>
    <description>Deming, linear, and rank-linear correlation coefficients (intercept, slope) were calculated for visit 1 regressed on visit 2 for both DCTclock and MMSE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)</measure>
    <time_frame>Visit 1 and visit 2, occurring 1-4 weeks apart</time_frame>
    <description>Pearson and Spearman correlation coefficients were calculated between visit 1 and visit 2 for DCTclock and MMSE, along with 95% CI.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments</measure>
    <time_frame>Visit 1 (day 1)</time_frame>
    <description>The goal of this analysis is to assess the construct validity of DCTclock. Specifically, the goal is to compare scores from the administration of DCTclock to the visit 1 administration of a battery of neuropsychological tests, to characterize the psychometric properties of DCTclock, and to compare those properties to the properties of MMSE.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of Serious Device-related Adverse Events [Safety]</measure>
    <time_frame>Visit 1 and visit 2, occuring 1-4 weeks apart</time_frame>
    <description>Incidence of serious device-related adverse events.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">450</enrollment>
  <condition>Cognitive Function</condition>
  <arm_group>
    <arm_group_label>All qualified participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received DCTclock, Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and a battery of other traditional pen and paper neuropsychological assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DCTclock</intervention_name>
    <description>DCTclock is a quick and non-invasive test that measures cognitive function based on a computerized algorithmic analysis of the entire drawing process and output of a well-established cognitive assessment called The Clock Drawing Test (CDT).</description>
    <arm_group_label>All qualified participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women 55 to 95 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ineligible for written informed consent.&#xD;
&#xD;
          -  Physical impairment of the writing hand.&#xD;
&#xD;
          -  Impaired manual dexterity.&#xD;
&#xD;
          -  Impaired vision.&#xD;
&#xD;
          -  Under the influence of recreational drugs or alcohol at the time of the visit.&#xD;
&#xD;
          -  Current or recent participation in a clinical trial that includes the use of a drug or&#xD;
             intervention to alter cognitive function.&#xD;
&#xD;
          -  Recent cognitive testing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonia H Holway, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Digital Cognition Technologies, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Compass Research</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lamar M, Ajilore O, Leow A, Charlton R, Cohen J, GadElkarim J, Yang S, Zhang A, Davis R, Penney D, Libon DJ, Kumar A. Cognitive and connectome properties detectable through individual differences in graphomotor organization. Neuropsychologia. 2016 May;85:301-9. doi: 10.1016/j.neuropsychologia.2016.03.034. Epub 2016 Mar 30.</citation>
    <PMID>27037044</PMID>
  </reference>
  <reference>
    <citation>Souillard-Mandar W, Davis R, Rudin C, Au R, Libon DJ, Swenson R, Price CC, Lamar M, Penney DL. Learning Classification Models of Cognitive Conditions from Subtle Behaviors in the Digital Clock Drawing Test. Mach Learn. 2016 Mar;102(3):393-441. doi: 10.1007/s10994-015-5529-5. Epub 2015 Oct 20.</citation>
    <PMID>27057085</PMID>
  </reference>
  <reference>
    <citation>Cohen J, Penney DL, Davis R, Libon DJ, Swenson RA, Ajilore O, Kumar A, Lamar M. Digital Clock Drawing: differentiating &quot;thinking&quot; versus &quot;doing&quot; in younger and older adults with depression. J Int Neuropsychol Soc. 2014 Oct;20(9):920-8. doi: 10.1017/S1355617714000757. Epub 2014 Sep 15.</citation>
    <PMID>25222513</PMID>
  </reference>
  <reference>
    <citation>Davis R, Libon DJ, Au R, Pitman D, Penney DL. THink: Inferring Cognitive Status from Subtle Behaviors. Proc AAAI Conf Artif Intell. 2014 Jul;2014:2898-2905.</citation>
    <PMID>27066307</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <results_first_submitted>January 24, 2018</results_first_submitted>
  <results_first_submitted_qc>March 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 3, 2018</results_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive assessment</keyword>
  <keyword>Cognition</keyword>
  <keyword>Clock Test</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not plan to share IPD</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03238001/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03238001/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at one site in the US.</recruitment_details>
      <pre_assignment_details>450 participants were enrolled. 14 did not meet screening criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Qualified Participants</title>
          <description>Participants received the DCTclock test and a battery of other traditional, pen and paper, neuropsychological assessments.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Visit 1 (Primary Endpoint Cohort)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="436"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="432"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unanalyzable test result</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Visit 2 (Secondary Endpoint Cohort)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="432"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="403"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unanalyzable test result</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Met exclusion criteria at visit 2</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study completion</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>All participants enrolled in the study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="450"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.94" spread="8.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="405"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="329"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Handedness</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Right handed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="396"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Left handed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ambidextrous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other or unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest education level attained</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>College Degree +</title>
                  <measurement_list>
                    <measurement group_id="B1" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High School and some college</title>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Less than high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)</title>
        <description>The primary analysis will assess agreement between DCTclock and the Montreal Cognitive Assessment (MoCA) and compare it to the agreement between the MMSE and MoCA at visit 1.</description>
        <time_frame>Visit 1 (day 1)</time_frame>
        <population>The Evaluable Population includes all qualified participants undergoing cognitive testing with DCTclock, MMSE, and MoCA who completed visit 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Endpoint (Evaluable) Population</title>
            <description>Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)</title>
          <description>The primary analysis will assess agreement between DCTclock and the Montreal Cognitive Assessment (MoCA) and compare it to the agreement between the MMSE and MoCA at visit 1.</description>
          <population>The Evaluable Population includes all qualified participants undergoing cognitive testing with DCTclock, MMSE, and MoCA who completed visit 1.</population>
          <units>Difference in Quadratic Weighted Kappas</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="432"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.035" lower_limit="-0.12" upper_limit="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A two-one-sided tests approach was taken, where, prior to analysis, it was determined that a delta (equivalence margin) of 0.20 would be considered a significant difference between the DCTclock/MoCA kappa and the MMSE/MoCA kappa. The reasoning behind this determination can be found in the study's statistical analysis plan.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>In order to show non-inferiority, a lower 90% confidence limit (CL) for the difference in kappa scores would need to be greater than or equal to -0.20. The 90% confidence interval was calculated based on 5000 bootstrapped differences in kappa scores.</non_inferiority_desc>
            <param_type>Lower 90% CL for difference in Kappas</param_type>
            <param_value>-0.12</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.12</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
            <estimate_desc>90% CI for Kappa of DCTclock/MoCA - Kappa of MMSE/MoCA (estimated with bootstrap method using 5000 bootstraps).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quadratic Weighted Kappa on Primary Endpoints</title>
        <description>Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA.</description>
        <time_frame>Visit 1 (day 1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DCTclock</title>
            <description>Participants received DCTclock and MoCA on their first visit.</description>
          </group>
          <group group_id="O2">
            <title>MMSE</title>
            <description>Participants received MMSE and MoCA on their first visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Quadratic Weighted Kappa on Primary Endpoints</title>
          <description>Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA.</description>
          <units>Quadratic Weighted Kappa</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="432"/>
                <count group_id="O2" value="432"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" lower_limit="0.32" upper_limit="0.49"/>
                    <measurement group_id="O2" value="0.44" lower_limit="0.36" upper_limit="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Agreement on Primary Endpoints</title>
        <description>Positive percent agreement, version A (treating the &quot;Indeterminate&quot; group as &quot;Unimpaired&quot;) and version B (removing the &quot;Indeterminate&quot; group from the analysis), and negative percent agreement version A and version B. These were calculated for the DCTclock/MoCA classification table as well as the MMSE/MoCA classification table. 95% CI were also calculated and compared between the two classification tables' calculations.</description>
        <time_frame>Visit 1 (day 1)</time_frame>
        <population>Version A treats the &quot;Indeterminate&quot; group as &quot;Unimpaired&quot;, while version B removes the &quot;Indeterminate&quot; group from the analysis. Thus, the analysis population for version B is smaller than the overall analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>DCTclock</title>
            <description>Participants received DCTclock and MoCA on their first visit.</description>
          </group>
          <group group_id="O2">
            <title>MMSE</title>
            <description>Participants received MMSE and MoCA on their first visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Agreement on Primary Endpoints</title>
          <description>Positive percent agreement, version A (treating the &quot;Indeterminate&quot; group as &quot;Unimpaired&quot;) and version B (removing the &quot;Indeterminate&quot; group from the analysis), and negative percent agreement version A and version B. These were calculated for the DCTclock/MoCA classification table as well as the MMSE/MoCA classification table. 95% CI were also calculated and compared between the two classification tables' calculations.</description>
          <population>Version A treats the &quot;Indeterminate&quot; group as &quot;Unimpaired&quot;, while version B removes the &quot;Indeterminate&quot; group from the analysis. Thus, the analysis population for version B is smaller than the overall analysis population.</population>
          <units>Percent Agreement</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="432"/>
                <count group_id="O2" value="432"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive - Version A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" lower_limit="0.57" upper_limit="0.71"/>
                    <measurement group_id="O2" value="0.56" lower_limit="0.49" upper_limit="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive - Version B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="268"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78" lower_limit="0.71" upper_limit="0.84"/>
                    <measurement group_id="O2" value="0.69" lower_limit="0.62" upper_limit="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative - Version A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74" lower_limit="0.69" upper_limit="0.80"/>
                    <measurement group_id="O2" value="0.83" lower_limit="0.78" upper_limit="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative - Version B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="268"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" lower_limit="0.64" upper_limit="0.81"/>
                    <measurement group_id="O2" value="0.88" lower_limit="0.81" upper_limit="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Regression Coefficients on Primary Endpoints</title>
        <description>Linear and rank-linear regression coefficients (slope, intercept) and 95% CI for DCTclock regressed on MoCA as well as for the MMSE regressed on MoCA.</description>
        <time_frame>Visit 1 (day 1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DCTclock</title>
            <description>Participants received DCTclock and MoCA on their first visit.</description>
          </group>
          <group group_id="O2">
            <title>MMSE</title>
            <description>Participants received MMSE and MoCA on their first visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Regression Coefficients on Primary Endpoints</title>
          <description>Linear and rank-linear regression coefficients (slope, intercept) and 95% CI for DCTclock regressed on MoCA as well as for the MMSE regressed on MoCA.</description>
          <units>Regression Coefficients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="432"/>
                <count group_id="O2" value="432"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Linear - Intercept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.35" lower_limit="18.64" upper_limit="20.07"/>
                    <measurement group_id="O2" value="-5.03" lower_limit="-8.73" upper_limit="-1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Linear - Slope</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" lower_limit="0.06" upper_limit="0.08"/>
                    <measurement group_id="O2" value="1.03" lower_limit="0.90" upper_limit="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rank-Linear - Intercept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107.75" lower_limit="87.37" upper_limit="128.12"/>
                    <measurement group_id="O2" value="96.45" lower_limit="76.43" upper_limit="116.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rank-Linear - Slope</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" lower_limit="0.42" upper_limit="0.58"/>
                    <measurement group_id="O2" value="0.55" lower_limit="0.47" upper_limit="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficients on Primary Endpoints</title>
        <description>Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA.</description>
        <time_frame>Visit 1 (day 1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DCTclock</title>
            <description>Participants received DCTclock and MoCA on their first visit</description>
          </group>
          <group group_id="O2">
            <title>MMSE</title>
            <description>Participants received MMSE and MoCA on their first visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficients on Primary Endpoints</title>
          <description>Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA.</description>
          <units>Correlation Coefficients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="432"/>
                <count group_id="O2" value="432"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pearson</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" lower_limit="0.46" upper_limit="0.60"/>
                    <measurement group_id="O2" value="0.59" lower_limit="0.53" upper_limit="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spearman</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" lower_limit="0.43" upper_limit="0.57"/>
                    <measurement group_id="O2" value="0.55" lower_limit="0.48" upper_limit="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)</title>
        <description>Quadratic weighted Cohen's Kappa statistics were calculated for both DCTclock and MMSE test-retest data (visit 1 vs visit 2).</description>
        <time_frame>Visit 1 and visit 2, occurring 1-4 weeks apart</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DCTclock</title>
            <description>Participants received DCTclock on their first and second visits, occurring 1-4 weeks apart.</description>
          </group>
          <group group_id="O2">
            <title>MMSE</title>
            <description>Participants received MMSE on their first and second visits, occurring 1-4 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)</title>
          <description>Quadratic weighted Cohen's Kappa statistics were calculated for both DCTclock and MMSE test-retest data (visit 1 vs visit 2).</description>
          <units>Quadratic Weighted Cohen's Kappa</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
                <count group_id="O2" value="403"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" lower_limit="0.45" upper_limit="0.60"/>
                    <measurement group_id="O2" value="0.48" lower_limit="0.39" upper_limit="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Agreement on Secondary Endpoints (Test-retest Reliability)</title>
        <description>Positive percent agreement version A (treating the &quot;Indeterminate&quot; group as &quot;Unimpaired&quot;) and version B (removing the &quot;Indeterminate&quot; group from the analysis), negative percent agreement version A and version B, indeterminate percent agreement, and unimpaired percent agreement.</description>
        <time_frame>Visit 1 and visit 2, occurring 1-4 weeks apart</time_frame>
        <population>Version A treats the &quot;Indeterminate&quot; group as &quot;Unimpaired&quot;, while version B removes the &quot;Indeterminate&quot; group from the analysis. Thus, the analysis population for version B is smaller than the overall analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>DCTclock</title>
            <description>Participants received DCTclock on their first and second visits, occurring 1-4 weeks apart.</description>
          </group>
          <group group_id="O2">
            <title>MMSE</title>
            <description>Participants received MMSE on their first and second visits, occurring 1-4 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Agreement on Secondary Endpoints (Test-retest Reliability)</title>
          <description>Positive percent agreement version A (treating the &quot;Indeterminate&quot; group as &quot;Unimpaired&quot;) and version B (removing the &quot;Indeterminate&quot; group from the analysis), negative percent agreement version A and version B, indeterminate percent agreement, and unimpaired percent agreement.</description>
          <population>Version A treats the &quot;Indeterminate&quot; group as &quot;Unimpaired&quot;, while version B removes the &quot;Indeterminate&quot; group from the analysis. Thus, the analysis population for version B is smaller than the overall analysis population.</population>
          <units>Percent Agreement</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
                <count group_id="O2" value="403"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive - Version A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="403"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" lower_limit="0.66" upper_limit="0.80"/>
                    <measurement group_id="O2" value="0.74" lower_limit="0.65" upper_limit="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive - Version B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="257"/>
                    <count group_id="O2" value="283"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" lower_limit="0.77" upper_limit="0.90"/>
                    <measurement group_id="O2" value="0.84" lower_limit="0.75" upper_limit="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative - Version A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="403"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" lower_limit="0.70" upper_limit="0.81"/>
                    <measurement group_id="O2" value="0.80" lower_limit="0.75" upper_limit="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative - Version B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="257"/>
                    <count group_id="O2" value="283"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" lower_limit="0.74" upper_limit="0.87"/>
                    <measurement group_id="O2" value="0.78" lower_limit="0.72" upper_limit="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="403"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" lower_limit="0.14" upper_limit="0.31"/>
                    <measurement group_id="O2" value="0.27" lower_limit="0.17" upper_limit="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unimpaired</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="403"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" lower_limit="0.54" upper_limit="0.68"/>
                    <measurement group_id="O2" value="0.63" lower_limit="0.57" upper_limit="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Regression Coefficients on Secondary Endpoints (Test-retest Reliability)</title>
        <description>Deming, linear, and rank-linear correlation coefficients (intercept, slope) were calculated for visit 1 regressed on visit 2 for both DCTclock and MMSE.</description>
        <time_frame>Visit 1 and visit 2, occurring 1-4 weeks apart</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DCTclock</title>
            <description>Participants received DCTclock on their first and second visits, occurring 1-4 weeks apart.</description>
          </group>
          <group group_id="O2">
            <title>MMSE</title>
            <description>Participants received MMSE on their first and second visits, occurring 1-4 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Regression Coefficients on Secondary Endpoints (Test-retest Reliability)</title>
          <description>Deming, linear, and rank-linear correlation coefficients (intercept, slope) were calculated for visit 1 regressed on visit 2 for both DCTclock and MMSE.</description>
          <units>Regression Coefficients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
                <count group_id="O2" value="403"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Deming - Intercept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.77" lower_limit="3.07" upper_limit="14.46"/>
                    <measurement group_id="O2" value="2.96" lower_limit="-0.46" upper_limit="6.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deming - Slope</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" lower_limit="0.85" upper_limit="1.00"/>
                    <measurement group_id="O2" value="0.91" lower_limit="0.79" upper_limit="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Linear - Intercept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.03" lower_limit="20.58" upper_limit="29.48"/>
                    <measurement group_id="O2" value="10.88" lower_limit="8.96" upper_limit="12.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Linear - Slope</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" lower_limit="0.60" upper_limit="0.73"/>
                    <measurement group_id="O2" value="0.62" lower_limit="0.55" upper_limit="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rank-Linear - Intercept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.48" lower_limit="49.51" upper_limit="83.46"/>
                    <measurement group_id="O2" value="91.16" lower_limit="72.43" upper_limit="109.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rank-Linear - Slope</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" lower_limit="0.60" upper_limit="0.74"/>
                    <measurement group_id="O2" value="0.55" lower_limit="0.47" upper_limit="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)</title>
        <description>Pearson and Spearman correlation coefficients were calculated between visit 1 and visit 2 for DCTclock and MMSE, along with 95% CI.</description>
        <time_frame>Visit 1 and visit 2, occurring 1-4 weeks apart</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DCTclock</title>
            <description>Participants received DCTclock on their first and second visits, occurring 1-4 weeks apart.</description>
          </group>
          <group group_id="O2">
            <title>MMSE</title>
            <description>Participants received MMSE on their first and second visits, occurring 1-4 weeks apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)</title>
          <description>Pearson and Spearman correlation coefficients were calculated between visit 1 and visit 2 for DCTclock and MMSE, along with 95% CI.</description>
          <units>Correlation Coefficients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
                <count group_id="O2" value="403"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pearson</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" lower_limit="0.64" upper_limit="0.75"/>
                    <measurement group_id="O2" value="0.67" lower_limit="0.61" upper_limit="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spearman</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" lower_limit="0.60" upper_limit="0.73"/>
                    <measurement group_id="O2" value="0.56" lower_limit="0.47" upper_limit="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments</title>
        <description>The goal of this analysis is to assess the construct validity of DCTclock. Specifically, the goal is to compare scores from the administration of DCTclock to the visit 1 administration of a battery of neuropsychological tests, to characterize the psychometric properties of DCTclock, and to compare those properties to the properties of MMSE.</description>
        <time_frame>Visit 1 (day 1)</time_frame>
        <population>Includes all qualified participants who completed testing at visit 1 and had evaluable data for each test analyzed. Roughly half of the population was administered the full neuropsychological battery. The remainder completed a partial battery (see protocol for details).</population>
        <group_list>
          <group group_id="O1">
            <title>DCTclock</title>
            <description>Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.</description>
          </group>
          <group group_id="O2">
            <title>MMSE</title>
            <description>Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments</title>
          <description>The goal of this analysis is to assess the construct validity of DCTclock. Specifically, the goal is to compare scores from the administration of DCTclock to the visit 1 administration of a battery of neuropsychological tests, to characterize the psychometric properties of DCTclock, and to compare those properties to the properties of MMSE.</description>
          <population>Includes all qualified participants who completed testing at visit 1 and had evaluable data for each test analyzed. Roughly half of the population was administered the full neuropsychological battery. The remainder completed a partial battery (see protocol for details).</population>
          <units>Correlation Coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="432"/>
                <count group_id="O2" value="432"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MMSE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" lower_limit="0.42" upper_limit="0.57"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Row = Column (correlation of MMSE to MMSE)</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MoCA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" lower_limit="0.46" upper_limit="0.60"/>
                    <measurement group_id="O2" value="0.59" lower_limit="0.53" upper_limit="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Benton Judgment of Line Orientation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" lower_limit="0.21" upper_limit="0.46"/>
                    <measurement group_id="O2" value="0.36" lower_limit="0.23" upper_limit="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Delis-Kaplan Executive Function- Letter Fluency</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="195"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" lower_limit="0.23" upper_limit="0.48"/>
                    <measurement group_id="O2" value="0.34" lower_limit="0.21" upper_limit="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Delis-Kaplan Executive Function-Category Fluency</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" lower_limit="0.27" upper_limit="0.50"/>
                    <measurement group_id="O2" value="0.37" lower_limit="0.24" upper_limit="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Delis-Kaplan Executive Function-Category Switching</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" lower_limit="0.16" upper_limit="0.42"/>
                    <measurement group_id="O2" value="0.38" lower_limit="0.25" upper_limit="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Delis-Kaplan Executive Function- Switch Accuracy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" lower_limit="0.13" upper_limit="0.39"/>
                    <measurement group_id="O2" value="0.36" lower_limit="0.24" upper_limit="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rey-Osterrieth Complex Figure- Copy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="182"/>
                    <count group_id="O2" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44" lower_limit="0.31" upper_limit="0.55"/>
                    <measurement group_id="O2" value="0.43" lower_limit="0.31" upper_limit="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rey-Osterrieth Complex Figure- Immediate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" lower_limit="0.31" upper_limit="0.54"/>
                    <measurement group_id="O2" value="0.31" lower_limit="0.17" upper_limit="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rey-Osterrieth Complex Figure- Delayed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" lower_limit="0.26" upper_limit="0.50"/>
                    <measurement group_id="O2" value="0.28" lower_limit="0.14" upper_limit="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rey-Osterrieth Complex Figure- Immediate Retention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" lower_limit="0.08" upper_limit="0.35"/>
                    <measurement group_id="O2" value="0.08" lower_limit="-0.06" upper_limit="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rey-Osterrieth Complex Figure- Delayed Retention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                    <count group_id="O2" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" lower_limit="-0.20" upper_limit="0.09"/>
                    <measurement group_id="O2" value="0.03" lower_limit="-0.11" upper_limit="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rey-Osterrieth Complex Figure- Organization</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" lower_limit="0.16" upper_limit="0.42"/>
                    <measurement group_id="O2" value="0.25" lower_limit="0.11" upper_limit="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WAIS-IV Digit Span</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="431"/>
                    <count group_id="O2" value="431"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" lower_limit="0.23" upper_limit="0.40"/>
                    <measurement group_id="O2" value="0.48" lower_limit="0.40" upper_limit="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WAIS-IV Block Design</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                    <count group_id="O2" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" lower_limit="0.27" upper_limit="0.51"/>
                    <measurement group_id="O2" value="0.42" lower_limit="0.29" upper_limit="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trail Making Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="431"/>
                    <count group_id="O2" value="431"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.48" lower_limit="0.40" upper_limit="0.55"/>
                    <measurement group_id="O2" value="0.45" lower_limit="0.38" upper_limit="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trail Making Part B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="420"/>
                    <count group_id="O2" value="420"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" lower_limit="0.41" upper_limit="0.56"/>
                    <measurement group_id="O2" value="0.51" lower_limit="0.44" upper_limit="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Geriatric Depression Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" lower_limit="-0.24" upper_limit="0.03"/>
                    <measurement group_id="O2" value="-0.04" lower_limit="-0.18" upper_limit="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symbol Digit Modalities</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="195"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51" lower_limit="0.39" upper_limit="0.60"/>
                    <measurement group_id="O2" value="0.49" lower_limit="0.37" upper_limit="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hamilton-Veale Contrast Sensitivity - Left</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" lower_limit="0.03" upper_limit="0.22"/>
                    <measurement group_id="O2" value="0.10" lower_limit="0.01" upper_limit="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hamilton-Veale Contrast Sensitivity- Right</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" lower_limit="-0.00" upper_limit="0.18"/>
                    <measurement group_id="O2" value="0.17" lower_limit="0.08" upper_limit="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hamilton-Veale Contrast Sensitivity- Binocular</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" lower_limit="0.14" upper_limit="0.32"/>
                    <measurement group_id="O2" value="0.21" lower_limit="0.11" upper_limit="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Purdue Peg Board- Left hand</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" lower_limit="0.24" upper_limit="0.41"/>
                    <measurement group_id="O2" value="0.16" lower_limit="0.07" upper_limit="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Purdue Peg Board- Right hand</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" lower_limit="0.27" upper_limit="0.43"/>
                    <measurement group_id="O2" value="0.22" lower_limit="0.12" upper_limit="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Purdue Peg Board- Bimanual</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" lower_limit="0.28" upper_limit="0.44"/>
                    <measurement group_id="O2" value="0.25" lower_limit="0.16" upper_limit="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence of Serious Device-related Adverse Events [Safety]</title>
        <description>Incidence of serious device-related adverse events.</description>
        <time_frame>Visit 1 and visit 2, occuring 1-4 weeks apart</time_frame>
        <population>All qualified participants who completed at least one DCTclock test.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Serious Device-related Adverse Events [Safety]</title>
          <description>Incidence of serious device-related adverse events.</description>
          <population>All qualified participants who completed at least one DCTclock test.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="432"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected at each study visit. The second (final) study visit occurred one to four weeks after the first visit, therefore, adverse event data was collected for a period of one to four weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>Participants received DCTclock, MMSE, MoCA, and a battery of other traditional, pen and paper neuropsychological assessments.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="436"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="436"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bone fracture</sub_title>
                <description>Accidental fall resulting in bone fracture.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="436"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="436"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>SVP, Clinical Affairs</name_or_title>
      <organization>Digital Cognition Technologies</organization>
      <phone>6174331777</phone>
      <email>aholway@digitalcogtech.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03238001
org study id: DCT032
nct id: NCT03238001
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The overall objective of this study is to demonstrate the safety and effectiveness of
      DCTclock as an adjunctive tool for use by clinicians to evaluate cognitive function in adults
      aged 55-95.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study uses a paired design in which each subject undergoes blinded testing by separate testers administering DCTclock and a battery of reference standard tests to determine cognitive state.
primary purpose: Screening
masking: None (Open Label)
measure: Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)
time frame: Visit 1 (day 1)
description: The primary analysis will assess agreement between DCTclock and the Montreal Cognitive Assessment (MoCA) and compare it to the agreement between the MMSE and MoCA at visit 1.
measure: Quadratic Weighted Kappa on Primary Endpoints
time frame: Visit 1 (day 1)
description: Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA.
measure: Percent Agreement on Primary Endpoints
time frame: Visit 1 (day 1)
description: Positive percent agreement, version A (treating the "Indeterminate" group as "Unimpaired") and version B (removing the "Indeterminate" group from the analysis), and negative percent agreement version A and version B. These were calculated for the DCTclock/MoCA classification table as well as the MMSE/MoCA classification table. 95% CI were also calculated and compared between the two classification tables' calculations.
measure: Regression Coefficients on Primary Endpoints
time frame: Visit 1 (day 1)
description: Linear and rank-linear regression coefficients (slope, intercept) and 95% CI for DCTclock regressed on MoCA as well as for the MMSE regressed on MoCA.
measure: Correlation Coefficients on Primary Endpoints
time frame: Visit 1 (day 1)
description: Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA.
measure: Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)
time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
description: Quadratic weighted Cohen's Kappa statistics were calculated for both DCTclock and MMSE test-retest data (visit 1 vs visit 2).
measure: Percent Agreement on Secondary Endpoints (Test-retest Reliability)
time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
description: Positive percent agreement version A (treating the "Indeterminate" group as "Unimpaired") and version B (removing the "Indeterminate" group from the analysis), negative percent agreement version A and version B, indeterminate percent agreement, and unimpaired percent agreement.
measure: Regression Coefficients on Secondary Endpoints (Test-retest Reliability)
time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
description: Deming, linear, and rank-linear correlation coefficients (intercept, slope) were calculated for visit 1 regressed on visit 2 for both DCTclock and MMSE.
measure: Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)
time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
description: Pearson and Spearman correlation coefficients were calculated between visit 1 and visit 2 for DCTclock and MMSE, along with 95% CI.
measure: Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments
time frame: Visit 1 (day 1)
description: The goal of this analysis is to assess the construct validity of DCTclock. Specifically, the goal is to compare scores from the administration of DCTclock to the visit 1 administration of a battery of neuropsychological tests, to characterize the psychometric properties of DCTclock, and to compare those properties to the properties of MMSE.
measure: Incidence of Serious Device-related Adverse Events [Safety]
time frame: Visit 1 and visit 2, occuring 1-4 weeks apart
description: Incidence of serious device-related adverse events.
arm group label: All qualified participants
arm group type: Experimental
description: Participants received DCTclock, Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and a battery of other traditional pen and paper neuropsychological assessments.
intervention type: Device
intervention name: DCTclock
description: DCTclock is a quick and non-invasive test that measures cognitive function based on a computerized algorithmic analysis of the entire drawing process and output of a well-established cognitive assessment called The Clock Drawing Test (CDT).
arm group label: All qualified participants
criteria: 
gender: All
minimum age: 55 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Antonia H Holway, Ph.D.
role: Study Director
affiliation: Digital Cognition Technologies, Inc.
facility: 
country: United States
citation: Lamar M, Ajilore O, Leow A, Charlton R, Cohen J, GadElkarim J, Yang S, Zhang A, Davis R, Penney D, Libon DJ, Kumar A. Cognitive and connectome properties detectable through individual differences in graphomotor organization. Neuropsychologia. 2016 May;85:301-9. doi: 10.1016/j.neuropsychologia.2016.03.034. Epub 2016 Mar 30.
PMID: 27037044
citation: Souillard-Mandar W, Davis R, Rudin C, Au R, Libon DJ, Swenson R, Price CC, Lamar M, Penney DL. Learning Classification Models of Cognitive Conditions from Subtle Behaviors in the Digital Clock Drawing Test. Mach Learn. 2016 Mar;102(3):393-441. doi: 10.1007/s10994-015-5529-5. Epub 2015 Oct 20.
PMID: 27057085
citation: Cohen J, Penney DL, Davis R, Libon DJ, Swenson RA, Ajilore O, Kumar A, Lamar M. Digital Clock Drawing: differentiating "thinking" versus "doing" in younger and older adults with depression. J Int Neuropsychol Soc. 2014 Oct;20(9):920-8. doi: 10.1017/S1355617714000757. Epub 2014 Sep 15.
PMID: 25222513
citation: Davis R, Libon DJ, Au R, Pitman D, Penney DL. THink: Inferring Cognitive Status from Subtle Behaviors. Proc AAAI Conf Artif Intell. 2014 Jul;2014:2898-2905.
PMID: 27066307
responsible party type: Sponsor
sharing ipd: No
ipd description: We do not plan to share IPD
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 