<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/NCT01672827</url>
  </required_header>
  <id_info>
    <org_study_id>GE-067-021</org_study_id>
    <nct_id>NCT01672827</nct_id>
  </id_info>
  <brief_title>Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images</brief_title>
  <official_title>A Study to Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GE Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To Evaluate the Effectiveness of an Electronic Training Program for Orienting and&#xD;
      Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.</measure>
    <time_frame>Post flutemetamol administration</time_frame>
    <description>Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.</measure>
    <time_frame>Post flutemetamol administration</time_frame>
    <description>Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inter-Reader Agreement of PET Images Without Anatomic Images</measure>
    <time_frame>Post Flutemetamol Injection</time_frame>
    <description>Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">276</enrollment>
  <condition>Alzheimer's Disease</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>[18F]Flutemetamol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[18F]Flutemetamol</intervention_name>
    <description>No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.</description>
    <arm_group_label>[18F]Flutemetamol</arm_group_label>
    <other_name>Flutemetamol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185&#xD;
             MBq to approximately 370 MBq.&#xD;
&#xD;
          -  The subject was classified as one of the following:&#xD;
&#xD;
               1. End-of-life subject who expired and underwent brain autopsy, with histochemical&#xD;
                  (HC) confirmation of brain amyloid status.&#xD;
&#xD;
               2. Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent&#xD;
                  brain biopsy, with HC confirmation of brain amyloid status.&#xD;
&#xD;
               3. Elderly healthy volunteer (age ≥55).&#xD;
&#xD;
               4. Young healthy volunteer (age ≤40).&#xD;
&#xD;
               5. Subject with probable Alzheimer Disease (pAD).&#xD;
&#xD;
               6. Subject with amnestic Mild Cognitive Impairment (aMCI).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not Applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Sherwin, MD</last_name>
    <role>Study Chair</role>
    <affiliation>GE Healthcare</affiliation>
  </overall_official>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>August 14, 2013</results_first_submitted>
  <results_first_submitted_qc>October 24, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 19, 2013</results_first_posted>
  <last_update_submitted>December 18, 2013</last_update_submitted>
  <last_update_submitted_qc>December 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <keyword>Positron Emission Tomography (PET)</keyword>
  <keyword>PET Images</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flutemetamol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study examined brain PET scans from 276 subjects previously acquired form various GE Healthcare studies (GE-067. The study did not enroll the blinded image Readers.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>[18F]Flutemetamol</title>
          <description>No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to show the PET Image Interpretations among investigators. The study did not enroll the blinded image Readers.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="276"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="276"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>[18F]Flutemetamol</title>
          <description>No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to evaluate the effectiveness of an electronic training program for orienting and interpreting Flutemetamol Positive Emission Tomography (PET) Images.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="276"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="68.2" spread="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.</title>
        <description>Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.</description>
        <time_frame>Post flutemetamol administration</time_frame>
        <population>Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had abnormal Standard of Truth (SoT).</population>
        <group_list>
          <group group_id="O1">
            <title>Sensitivity %</title>
            <description>Sensitivity of the blinded visual PET Image Interpretations without Anatomic Images.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.</title>
          <description>Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.</description>
          <population>Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had abnormal Standard of Truth (SoT).</population>
          <units>Percentage (True Positive)</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="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Reader 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94" lower_limit="84" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" lower_limit="81" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" lower_limit="79" upper_limit="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94" lower_limit="84" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" lower_limit="71" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Majority Read</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94" lower_limit="84" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inter-Reader Agreement of PET Images Without Anatomic Images</title>
        <description>Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.</description>
        <time_frame>Post Flutemetamol Injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Inter-Reader Agreement</title>
            <description>Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images.</description>
          </group>
        </group_list>
        <measure>
          <title>Inter-Reader Agreement of PET Images Without Anatomic Images</title>
          <description>Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.</description>
          <units>Number of inter-reader agreements</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Reader 1 vs Reader 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="248" lower_limit="73" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 1 vs Reader 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="257" lower_limit=".80" upper_limit=".92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 1 vs Reader 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="242" lower_limit=".68" upper_limit=".83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 1 vs Reader 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="251" lower_limit=".75" upper_limit=".89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 2 vs Reader 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="255" lower_limit=".79" upper_limit=".91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 2 vs Reader 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="250" lower_limit=".74" upper_limit=".88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 2 vs Reader 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="251" lower_limit=".75" upper_limit=".89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 3 vs Reader 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="253" lower_limit=".77" upper_limit=".90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 3 vs Reader 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="268" lower_limit=".90" upper_limit=".98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 4 vs Reader 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="245" lower_limit=".71" upper_limit=".85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Readers 1,2,3,4,5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="223" lower_limit=".79" upper_limit=".86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.</title>
        <description>Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.</description>
        <time_frame>Post flutemetamol administration</time_frame>
        <population>Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had normal Standard of Truth (SoT).</population>
        <group_list>
          <group group_id="O1">
            <title>Specificity %</title>
            <description>Specificity of the blinded visual PET Image Interpretations without Anatomic Images.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.</title>
          <description>Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.</description>
          <population>Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had normal Standard of Truth (SoT).</population>
          <units>Percentage (True Negative)</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="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Reader 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79" lower_limit="68" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81" lower_limit="71" upper_limit="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" lower_limit="85" upper_limit="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77" lower_limit="67" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reader 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96" lower_limit="90" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Majority Read</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" lower_limit="84" upper_limit="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>No adverse event data collected because no subjects were dosed in this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>[18F]Flutemetamol</title>
          <description>No adverse event data collected because no subjects were dosed in this study , therefore no subjects were at risk.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
              </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>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Paul Sherwin, M.D.</name_or_title>
      <organization>GE Healthcare</organization>
      <phone>1-609-514-6820</phone>
      <email>paulsherwin@ge.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/NCT01672827
org study id: GE-067-021
nct id: NCT01672827
lead sponsor: 
has dmc: No
To Evaluate the Effectiveness of an Electronic Training Program for Orienting and
      Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.
time frame: Post flutemetamol administration
description: Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.
measure: Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.
time frame: Post flutemetamol administration
description: Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.
measure: Inter-Reader Agreement of PET Images Without Anatomic Images
time frame: Post Flutemetamol Injection
description: Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.
arm group label: [18F]Flutemetamol
arm group type: Experimental
intervention type: Drug
intervention name: [18F]Flutemetamol
description: No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.
arm group label: [18F]Flutemetamol
other name: Flutemetamol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Sherwin, MD
role: Study Chair
affiliation: GE Healthcare
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction
mesh term: Flutemetamol
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 