<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/NCT01662882</url>
  </required_header>
  <id_info>
    <org_study_id>18F-AV-45-J05</org_study_id>
    <secondary_id>I6E-AV-AVBB</secondary_id>
    <nct_id>NCT01662882</nct_id>
  </id_info>
  <brief_title>A Phase II Trial of Florbetapir (18F) Positron Emission Tomography (PET) Imaging in Japan of Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)</brief_title>
  <official_title>An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of Florbetapir (18F) in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Avid Radiopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Avid Radiopharmaceuticals</source>
  <brief_summary>
    <textblock>
      Evaluate florbetapir (18F) positron emission tomography (PET) imaging for distinguishing&#xD;
      Japanese healthy control subjects, from Japanese subjects with Alzheimer's disease (AD) or&#xD;
      Mild cognitive impairment (MCI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative Amyloid Image Assessment</measure>
    <time_frame>50-60 min after injection</time_frame>
    <description>Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Cortical to Cerebellum SUVR</measure>
    <time_frame>50-60 min after injection</time_frame>
    <description>Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Alzheimer's Disease</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>AD Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MCI (mild cognitive impairment)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>florbetapir (18F)</intervention_name>
    <description>IV injection, 370 MBq(10mCi), single dose</description>
    <arm_group_label>AD Subjects</arm_group_label>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_label>MCI</arm_group_label>
    <other_name>18F-AV-45</other_name>
    <other_name>Amyvid</other_name>
    <other_name>Florbetapir F 18</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects who meet all of the following criteria are eligible to enroll in the arm of this&#xD;
        trial reserved for subjects with AD:&#xD;
&#xD;
          1. Japanese males or females at least 50 years of age, with probable AD according to the&#xD;
             NINCDS-ADRDA criteria (McKhann et al., 1984);&#xD;
&#xD;
          2. Subjects with mild/moderate dementia as evidenced by a MMSE score ranging from 10 to&#xD;
             24, boundaries included, at screening;&#xD;
&#xD;
          3. Subjects whose history of cognitive decline has been gradual in onset and progressive&#xD;
             over a period of at least 6 months. Evidence should be present indicating sustained&#xD;
             memory deterioration in an otherwise cognitively normal subject, plus additional&#xD;
             impairment in another cognitive function such as: orientation, judgment and problem&#xD;
             solving, or functioning in personal care;&#xD;
&#xD;
          4. Subjects who live with or have regular visits from a responsible caregiver willing to&#xD;
             provide information about the subject's cognitive status; and&#xD;
&#xD;
          5. Subjects who signed an Institutional Review Board/Independent Ethics Committee&#xD;
             (IRB/IEC) approved informed consent prior to any study procedures. If the subject is&#xD;
             incapable of giving informed consent, the caregiver may consent on behalf of the&#xD;
             subject (the subject must still confirm assent).&#xD;
&#xD;
        Subjects who meet all of the following criteria are eligible to enroll in the arm of this&#xD;
        trial reserved for subjects with mild cognitive impairment:&#xD;
&#xD;
          1. Japanese males or females at least 50 years of age;&#xD;
&#xD;
          2. Subjects with complaint of memory or cognitive decline corroborated by an informant;&#xD;
&#xD;
          3. Subjects with a Clinical Dementia Rating (CDR) of 0.5;&#xD;
&#xD;
          4. Subjects with objective cognitive impairment or marginally normal cognition with a&#xD;
             documented history of high cognitive performance;&#xD;
&#xD;
          5. Have no obvious causes for their cognitive impairment (e.g., onset coincides with&#xD;
             recent head trauma or stroke);&#xD;
&#xD;
          6. Have sufficiently preserved general cognition and functional performance such that a&#xD;
             diagnosis of AD cannot be made at the time of the screening visit;&#xD;
&#xD;
          7. Subjects with essentially normal ADL;&#xD;
&#xD;
          8. Subjects who are not demented;&#xD;
&#xD;
          9. Subjects with an MMSE score &gt; 24;&#xD;
&#xD;
         10. Subjects who are presenting for initial diagnosis of cognitive impairment or who have&#xD;
             presented for initial diagnosis of cognitive impairment within the past year;&#xD;
&#xD;
         11. Subjects who live with or have regular visits from a responsible caregiver willing to&#xD;
             provide information about the subject's cognitive status; and&#xD;
&#xD;
         12. Subjects who signed an IRB/IEC approved informed consent prior to any study&#xD;
             procedures.&#xD;
&#xD;
        Subjects who meet all of the following criteria are eligible to enroll in the arm of this&#xD;
        trial reserved for cognitively normal volunteers:&#xD;
&#xD;
          1. Japanese males or females at least 50 years of age;&#xD;
&#xD;
          2. Subjects with an MMSE score &gt;= 29, and are cognitively normal based on history and&#xD;
             psychometric test battery at screening;&#xD;
&#xD;
          3. Subjects who live with or have a reliable person who can verify their cognitive&#xD;
             status; and&#xD;
&#xD;
          4. Subjects who signed an IRB/IEC approved informed consent prior to any study&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects with any of the following are ineligible to enroll in this trial:&#xD;
&#xD;
          1. A documented diagnosis of MCI for greater than 1 year (for subjects considered for the&#xD;
             MCI group);&#xD;
&#xD;
          2. Neurodegenerative disorders other than AD, including, but not limited to Parkinson's&#xD;
             disease, Pick's disease, frontotemporal dementia, Huntington's chorea, Down's&#xD;
             syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive&#xD;
             supranuclear palsy;&#xD;
&#xD;
          3. Have had or currently have a diagnosis of other dementing / neurodegenerative disease&#xD;
             (e.g. Parkinson's disease, dementia with Lewy bodies, Lewy body variant AD, etc.);&#xD;
&#xD;
          4. Have had or currently have a diagnosis of mixed dementia;&#xD;
&#xD;
          5. Cognitive impairment resulting from:&#xD;
&#xD;
               -  Acute cerebral trauma or post-traumatic brain injury, subdural hematoma, or&#xD;
                  injuries secondary to chronic trauma (e.g. sequela from boxing);&#xD;
&#xD;
               -  Hypoxic cerebral damage regardless of etiology; e.g. cognitive or neurological&#xD;
                  deficits resulting from cardiac arrest or cardiac surgery, anesthesia, or severe&#xD;
                  self-poisoning episode, secondary to severe hypovolemia (orthostatic hypotension&#xD;
                  should not lead to exclusion);&#xD;
&#xD;
               -  Vitamin deficiency states documented by medical history such as folate, vitamin B&#xD;
                  12 and other B complex deficiencies; e.g. thiamin deficiency in Korsakoff's&#xD;
                  syndrome. (Note: subjects taking regular B12 and folate are not necessarily&#xD;
                  excluded);&#xD;
&#xD;
               -  Cerebral infection including abscess, syphilis, meningitis, encephalitis or AIDS;&#xD;
&#xD;
               -  Primary or metastatic cerebral neoplasia;&#xD;
&#xD;
               -  Significant endocrine or metabolic disease; e.g., thyroid, parathyroid, or&#xD;
                  pituitary disease, Cushing's syndrome, or severe renal failure; or&#xD;
&#xD;
               -  Mental retardation. Before enrolling a subject with past or current history of&#xD;
                  any of the above conditions, the investigator must contact the sponsor to discuss&#xD;
                  whether the condition could have contributed to the cognitive impairment.&#xD;
&#xD;
          6. Clinically significant infarct or possible multi-infarct dementia as defined by the&#xD;
             NINCDS criteria, including:&#xD;
&#xD;
               -  A history of a significant cerebrovascular event resulting in a physical or&#xD;
                  neurologic deficit that may confound the assessment of the subject's intellectual&#xD;
                  function;&#xD;
&#xD;
               -  Multiple focal signs on neurologic examination indicative of multiple ischemic&#xD;
                  episodes;&#xD;
&#xD;
               -  One or more of the following findings on a MRI scan:&#xD;
&#xD;
                    -  Multiple (two or more) infarcts or white matter lacunes;&#xD;
&#xD;
                    -  A single large infarct or a strategically placed infarct in the angular&#xD;
                       gyrus, the thalamus, the basal forebrain, the posterior cerebral artery&#xD;
                       (PCA) or anterior cerebral artery (ACA) territory;&#xD;
&#xD;
               -  Extensive periventricular white matter disease. Leukoaraiosis (periventricular&#xD;
                  white matter, low attenuation) should be distinguished from multiple infarctions.&#xD;
                  Leukoaraiosis is common in normal individuals and patients with AD. White matter&#xD;
                  deterioration should not result in exclusion unless it is abnormal and&#xD;
                  widespread, e.g., Binswanger's disease;&#xD;
&#xD;
          7. Any evidence on screening MRI, computed tomography (CT), or other biomarker studies&#xD;
             that suggests an alternate etiology (other than probable AD in subjects with AD) for&#xD;
             cognitive deficit; or in the case of cognitively normal controls any evidence on&#xD;
             screening MRI, CT, or other biomarker studies that suggests the presence of AD&#xD;
             pathology;&#xD;
&#xD;
          8. Current clinically significant psychiatric disease, as judged by Diagnostic and&#xD;
             Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria, particularly&#xD;
             current major depression or schizophrenia. Subjects with dementia who are experiencing&#xD;
             behavioral disturbances that may require treatment with psychotropic medications may&#xD;
             be entered only after discussion and with the approval of the sponsor. The&#xD;
             investigator and sponsor should carefully consider whether subjects with behavioral&#xD;
             dysfunction will be able to complete the imaging session;&#xD;
&#xD;
          9. History of epilepsy or convulsions, except for febrile convulsions during childhood;&#xD;
&#xD;
         10. Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine&#xD;
             disturbances;&#xD;
&#xD;
         11. Current clinically significant cardiovascular disease. Clinically significant&#xD;
             cardiovascular disease usually includes one or more of the following:&#xD;
&#xD;
               -  cardiac surgery or myocardial infarction within the last 6 months;&#xD;
&#xD;
               -  unstable angina;&#xD;
&#xD;
               -  coronary artery disease that required an increase in medication within the last 3&#xD;
                  months;&#xD;
&#xD;
               -  decompensated congestive heart failure;&#xD;
&#xD;
               -  significant cardiac arrhythmia or conduction disturbance, particularly those&#xD;
                  resulting in atrial or ventricular fibrillation, or causing syncope, near&#xD;
                  syncope, or other alterations in mental status;&#xD;
&#xD;
               -  severe mitral or aortic valvular disease;&#xD;
&#xD;
               -  uncontrolled high blood pressure;&#xD;
&#xD;
               -  congenital heart disease;&#xD;
&#xD;
               -  clinically significant abnormal result on ECG, including but not limited to QTc &gt;&#xD;
                  450 msec. Before enrolling a subject with any of the above conditions, the&#xD;
                  investigator must contact the sponsor.&#xD;
&#xD;
         12. History of drug or alcohol abuse within the last year, or prior prolonged history of&#xD;
             abuse;&#xD;
&#xD;
         13. Clinically significant infectious disease, including Acquired Immune Deficiency&#xD;
             Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection or previous positive&#xD;
             test for hepatitis;&#xD;
&#xD;
         14. Females of childbearing potential who are not surgically sterile, not refraining from&#xD;
             sexual activity or not using reliable methods of contraception. Females of&#xD;
             childbearing potential must not be pregnant (negative serum beta-hCG at the time of&#xD;
             screening and negative urine beta-hCG on the day of imaging) or breastfeeding at&#xD;
             screening. Females must agree to avoid becoming pregnant, and must agree to refrain&#xD;
             from sexual activity or to use reliable contraceptive methods such as prescribed birth&#xD;
             control or IUD for 24 hours following administration of florbetapir (18F);&#xD;
&#xD;
         15. Subjects who, in the opinion of the investigator, are otherwise unsuitable for a study&#xD;
             of this type;&#xD;
&#xD;
         16. History of relevant severe drug allergy or hypersensitivity;&#xD;
&#xD;
         17. Subjects who have received an investigational medication within the last 30 days.&#xD;
&#xD;
             Additionally, the time between the last dose of the previous experimental medication&#xD;
             and enrollment (completion of screening assessments) must be at least equal to 5 times&#xD;
             the terminal half-life of the previous experimental medication. Subjects who have ever&#xD;
             participated in an experimental study with an amyloid targeting therapy (e.g.,&#xD;
             immunotherapy, secretase inhibitor) may not be enrolled unless it can be demonstrated&#xD;
             that the subject received only placebo in the course of the trial;&#xD;
&#xD;
         18. Subjects with current clinically significant medical comorbidities, as indicated by&#xD;
             history, physical exam, ECG (including but not limited to QTc&gt;450 msec) or laboratory&#xD;
             evaluations, that might pose a potential safety risk, interfere with the absorption or&#xD;
             metabolism of the study medication or limit interpretation of the trial results. These&#xD;
             include but are not limited to clinically significant hepatic, renal, pulmonary,&#xD;
             metabolic or endocrine disease, cancer, HIV infection and AIDS;&#xD;
&#xD;
         19. Subjects who have known hypersensitivity to alcohol; and&#xD;
&#xD;
         20. Subjects who received a radiopharmaceutical for imaging or therapy within the past 7&#xD;
             days prior to the imaging session for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chief Medical Officer</last_name>
    <role>Study Director</role>
    <affiliation>Avid Radiopharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kobe</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>July 16, 2013</results_first_submitted>
  <results_first_submitted_qc>July 16, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 19, 2013</results_first_posted>
  <last_update_submitted>July 16, 2013</last_update_submitted>
  <last_update_submitted_qc>July 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AD Subjects</title>
          <description>florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
        </group>
        <group group_id="P2">
          <title>Healthy Controls</title>
          <description>florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
        </group>
        <group group_id="P3">
          <title>MCI Subjects</title>
          <description>MCI (mild cognitive impairment)&#xD;
florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AD Subjects</title>
          <description>florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
        </group>
        <group group_id="B2">
          <title>Healthy Controls</title>
          <description>florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
        </group>
        <group group_id="B3">
          <title>MCI Subjects</title>
          <description>MCI (mild cognitive impairment)&#xD;
florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>participants</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.3" spread="7.80"/>
                    <measurement group_id="B2" value="70.0" spread="11.15"/>
                    <measurement group_id="B3" value="73.3" spread="5.09"/>
                    <measurement group_id="B4" value="72.1" spread="8.57"/>
                  </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="14"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="18"/>
                  </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>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Qualitative Amyloid Image Assessment</title>
        <description>Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.</description>
        <time_frame>50-60 min after injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AD Subjects</title>
            <description>florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
          </group>
          <group group_id="O2">
            <title>MCI Subjects</title>
            <description>MCI (mild cognitive impairment)&#xD;
florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
          </group>
          <group group_id="O3">
            <title>Healthy Controls</title>
            <description>florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
          </group>
        </group_list>
        <measure>
          <title>Qualitative Amyloid Image Assessment</title>
          <description>Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive for amyloid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative for amyloid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0253</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0004</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4184</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Cortical to Cerebellum SUVR</title>
        <description>Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.</description>
        <time_frame>50-60 min after injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AD Subjects</title>
            <description>florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
          </group>
          <group group_id="O2">
            <title>MCI Subjects</title>
            <description>MCI (mild cognitive impairment)&#xD;
florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
          </group>
          <group group_id="O3">
            <title>Healthy Controls</title>
            <description>florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Cortical to Cerebellum SUVR</title>
          <description>Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.</description>
          <units>SUVR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.271" spread="0.182"/>
                    <measurement group_id="O2" value="1.112" spread="0.197"/>
                    <measurement group_id="O3" value="1.022" spread="0.220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0039</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis of variance contrast P value testing for difference in the mean cortical SUVR</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0357</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis of variance contrast P value testing for difference in the mean cortical SUVR</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0010</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis of variance contrast P value testing for difference in the mean cortical SUVR</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2118</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>AD Subjects</title>
          <description>florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
        </group>
        <group group_id="E2">
          <title>MCI Subjects</title>
          <description>MCI (mild cognitive impairment)&#xD;
florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</description>
        </group>
        <group group_id="E3">
          <title>Healthy Controls</title>
          <description>florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Avid Radiopharmaceuticals, Inc.</organization>
      <phone>215-298-0700</phone>
      <email>clinicaloperations@avidrp.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/NCT01662882
org study id: 18F-AV-45-J05
secondary id: I6E-AV-AVBB
nct id: NCT01662882
lead sponsor: 
collaborator: 
Evaluate florbetapir (18F) positron emission tomography (PET) imaging for distinguishing
      Japanese healthy control subjects, from Japanese subjects with Alzheimer's disease (AD) or
      Mild cognitive impairment (MCI).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Qualitative Amyloid Image Assessment
time frame: 50-60 min after injection
description: Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
measure: Mean Cortical to Cerebellum SUVR
time frame: 50-60 min after injection
description: Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
arm group label: AD Subjects
arm group type: Experimental
arm group label: MCI
arm group type: Experimental
description: MCI (mild cognitive impairment)
arm group label: Healthy Controls
arm group type: Experimental
intervention type: Drug
intervention name: florbetapir (18F)
description: IV injection, 370 MBq(10mCi), single dose
arm group label: AD Subjects
arm group label: Healthy Controls
arm group label: MCI
other name: 18F-AV-45
other name: Amyvid
other name: Florbetapir F 18
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chief Medical Officer
role: Study Director
affiliation: Avid Radiopharmaceuticals
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 