<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/NCT04468347</url>
  </required_header>
  <id_info>
    <org_study_id>18F-AV-1451-A08</org_study_id>
    <nct_id>NCT04468347</nct_id>
  </id_info>
  <brief_title>Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease</brief_title>
  <official_title>18F-AV-1451 PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Avid Radiopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Avid Radiopharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the&#xD;
      preclinical, prodromal and dementia phases of Alzheimer's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Australian Imaging Biomarkers and Lifestyle Study (AIBL) is a multicenter&#xD;
      multidisciplinary study of Alzheimer's disease and aging funded by the Commonwealth&#xD;
      Scientific and Industrial Research Organisation (CSIRO) Flagship Initiative, involving&#xD;
      research centers in both Victoria and Western Australia. The goal of the A08 protocol was to&#xD;
      further investigate the positron emission tomography (PET) imaging results with flortaucipir&#xD;
      in patients across the AD spectrum from individuals with subjective memory complaints (SMC)&#xD;
      to those with dementia, based on recruitment into the parent AIBL study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flortaucipir PET Imaging (Quantitative)</measure>
    <time_frame>baseline scan</time_frame>
    <description>Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status</measure>
    <time_frame>baseline scan</time_frame>
    <description>Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status</measure>
    <time_frame>baseline scan</time_frame>
    <description>Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Alzheimer's disease (AD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild cognitive impairment (MCI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjective memory complainers (SMC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitively normal (CN)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flortaucipir F18</intervention_name>
    <description>IV injection, 240 megabecquerel (MBq) (6.5 mCi)</description>
    <arm_group_label>Alzheimer's disease (AD)</arm_group_label>
    <arm_group_label>Cognitively normal (CN)</arm_group_label>
    <arm_group_label>Mild cognitive impairment (MCI)</arm_group_label>
    <arm_group_label>Subjective memory complainers (SMC)</arm_group_label>
    <other_name>18F-AV-1451</other_name>
    <other_name>[F-18]T807</other_name>
    <other_name>LY3191748</other_name>
    <other_name>Tauvid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Brain PET scan</intervention_name>
    <description>positron emission tomography (PET) scan of the brain</description>
    <arm_group_label>Alzheimer's disease (AD)</arm_group_label>
    <arm_group_label>Cognitively normal (CN)</arm_group_label>
    <arm_group_label>Mild cognitive impairment (MCI)</arm_group_label>
    <arm_group_label>Subjective memory complainers (SMC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or&#xD;
             planned and MRI available&#xD;
&#xD;
          -  Subjects in the MCI and AD groups required to have a reliable caregiver capable of&#xD;
             providing information about the subjects' symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder&#xD;
&#xD;
          -  history of electroconvulsive therapy&#xD;
&#xD;
          -  MRI contraindicated&#xD;
&#xD;
          -  claustrophobic or, otherwise, unable to tolerate the imaging procedure&#xD;
&#xD;
          -  current clinically significant cardiovascular disease or clinically significant&#xD;
             abnormalities on screening electrocardiogram&#xD;
&#xD;
          -  history of additional risk factors for Torsades de Pointes&#xD;
&#xD;
          -  current clinically significant infectious disease, endocrine or metabolic disease, or&#xD;
             pulmonary, renal, or hepatic impairment that the investigator believes would affect&#xD;
             study participation&#xD;
&#xD;
          -  history of cancer (other than skin or in situ prostate cancer) within the previous 5&#xD;
             years&#xD;
&#xD;
          -  current drug or alcohol abuse/dependence&#xD;
&#xD;
          -  history of alcohol abuse/dependence with 2 years of the onset of the symptoms of&#xD;
             dementia&#xD;
&#xD;
          -  females of childbearing potential who were not surgically sterile, not refraining from&#xD;
             sexual activity, or not using reliable methods of contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 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, Inc.</affiliation>
  </overall_official>
  <link>
    <url>http://aibl.csiro.au/</url>
    <description>Link to the Australian Imaging, Biomarker &amp; Lifestyle Flagship Study of Ageing (AIBL) website</description>
  </link>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <results_first_submitted>July 27, 2020</results_first_submitted>
  <results_first_submitted_qc>September 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 25, 2020</results_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2020</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>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <provided_document_section>
    <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>February 28, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT04468347/Prot_000.pdf</document_url>
    </provided_document>
    <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>June 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT04468347/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment occurred between Oct 2014 and Feb 2018 from the Australian Imaging, Biomarker &amp; Lifestyle Flagship Study of Ageing (AIBL)</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Alzheimer's Disease (AD)</title>
          <description>Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
        <group group_id="P2">
          <title>Mild Cognitive Impairment (MCI)</title>
          <description>Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
        <group group_id="P3">
          <title>Subjective Memory Complainers (SMC)</title>
          <description>Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
        <group group_id="P4">
          <title>Cognitively Normal (CN)</title>
          <description>Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="47"/>
                <participants group_id="P4" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Baseline Flortacuipir PET Scan</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="41"/>
                <participants group_id="P4" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Alzheimer's Disease (AD)</title>
          <description>Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
        <group group_id="B2">
          <title>Mild Cognitive Impairment (MCI)</title>
          <description>Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
        <group group_id="B3">
          <title>Subjective Memory Complainers (SMC)</title>
          <description>Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
        <group group_id="B4">
          <title>Cognitively Normal (CN)</title>
          <description>Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
        <group group_id="B5">
          <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="5"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="45"/>
            <count group_id="B4" value="25"/>
            <count group_id="B5" value="86"/>
          </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="76.2" spread="6.53"/>
                    <measurement group_id="B2" value="74.3" spread="5.82"/>
                    <measurement group_id="B3" value="77" spread="7.43"/>
                    <measurement group_id="B4" value="72.9" spread="4.67"/>
                    <measurement group_id="B5" value="75.4" spread="6.64"/>
                  </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="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="41"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </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>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mini Mental Status Exam (MMSE)</title>
          <description>Mini-mental status exam (MMSE) is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.6" spread="3.21"/>
                    <measurement group_id="B2" value="25.5" spread="2.84"/>
                    <measurement group_id="B3" value="28" spread="1.66"/>
                    <measurement group_id="B4" value="28.6" spread="0.99"/>
                    <measurement group_id="B5" value="27.5" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Flortaucipir PET Imaging (Quantitative)</title>
        <description>Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.</description>
        <time_frame>baseline scan</time_frame>
        <population>Inclusion in this analysis required that the subject's flortaucipir scan was analyzable for SUVr (1 AD, 1 MCI, 5 SMC, and 3 CN were not analyzable)</population>
        <group_list>
          <group group_id="O1">
            <title>Alzheimer's Disease (AD)</title>
            <description>Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
          <group group_id="O2">
            <title>Mild Cognitive Impairment (MCI)</title>
            <description>Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
          <group group_id="O3">
            <title>Objectively Impaired</title>
            <description>Combined AD and MCI group</description>
          </group>
          <group group_id="O4">
            <title>Subjective Memory Complainers (SMC)</title>
            <description>Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
          <group group_id="O5">
            <title>Cognitively Normal (CN)</title>
            <description>Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
          <group group_id="O6">
            <title>Non-objectively Compared</title>
            <description>Combined SMC and CN groups</description>
          </group>
        </group_list>
        <measure>
          <title>Flortaucipir PET Imaging (Quantitative)</title>
          <description>Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.</description>
          <population>Inclusion in this analysis required that the subject's flortaucipir scan was analyzable for SUVr (1 AD, 1 MCI, 5 SMC, and 3 CN were not analyzable)</population>
          <units>standardized uptake value ratio (SUVr)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="40"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.31" spread="0.059"/>
                    <measurement group_id="O2" value="1.13" spread="0.033"/>
                    <measurement group_id="O3" value="1.15" spread="0.031"/>
                    <measurement group_id="O4" value="1.08" spread="0.016"/>
                    <measurement group_id="O5" value="1.04" spread="0.028"/>
                    <measurement group_id="O6" value="1.07" spread="0.015"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
            <method_desc>The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.038</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>ANOVA</method>
            <method_desc>The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.038</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2161</p_value>
            <method>ANOVA</method>
            <method_desc>The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.033</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status</title>
        <description>Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.</description>
        <time_frame>baseline scan</time_frame>
        <population>Rows display flortaucipir scan results by subjects who were amyloid positive and amyloid negative at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Alzheimer's Disease (AD)</title>
            <description>Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
          <group group_id="O2">
            <title>Mild Cognitive Impairment (MCI)</title>
            <description>Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
          <group group_id="O3">
            <title>Subjective Memory Complainers (SMC)</title>
            <description>Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
          <group group_id="O4">
            <title>Cognitively Normal (CN)</title>
            <description>Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status</title>
          <description>Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.</description>
          <population>Rows display flortaucipir scan results by subjects who were amyloid positive and amyloid negative at baseline</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="5"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="45"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Amyloid Positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Advanced AD Scan Pattern (τAD++)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Advanced AD Pattern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amyloid Negative</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="25"/>
                    <count group_id="O4" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Advanced AD Scan Pattern (τAD++)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Advanced AD Pattern</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="20"/>
                  </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>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1998</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status</title>
        <description>Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.</description>
        <time_frame>baseline scan</time_frame>
        <population>Rows display flortaucipir scan results by subjects who were amyloid positive and amyloid negative at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Alzheimer's Disease (AD)</title>
            <description>Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
          <group group_id="O2">
            <title>Mild Cognitive Impairment (MCI)</title>
            <description>Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
          <group group_id="O3">
            <title>Subjective Memory Complainers (SMC)</title>
            <description>Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
          <group group_id="O4">
            <title>Cognitively Normal (CN)</title>
            <description>Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status</title>
          <description>Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.</description>
          <population>Rows display flortaucipir scan results by subjects who were amyloid positive and amyloid negative at baseline.</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="5"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="45"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Amyloid Positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>AD Pattern Scan (Advanced or Moderate)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not AD Pattern Scan</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amyloid Negative</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="25"/>
                    <count group_id="O4" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>AD Pattern Scan (Advanced or Moderate)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not AD Pattern Scan</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="20"/>
                  </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>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0646</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.</time_frame>
      <desc>Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.</desc>
      <group_list>
        <group group_id="E1">
          <title>Alzheimer's Disease (AD)</title>
          <description>Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
        <group group_id="E2">
          <title>Mild Cognitive Impairment (MCI)</title>
          <description>Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
        <group group_id="E3">
          <title>Subjective Memory Complainers (SMC)</title>
          <description>Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
        <group group_id="E4">
          <title>Cognitively Normal (CN)</title>
          <description>Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months</description>
        </group>
      </group_list>
      <serious_events>
        <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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.5</frequency_threshold>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </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="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </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>Medical Director</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/NCT04468347
org study id: 18F-AV-1451-A08
nct id: NCT04468347
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the
      preclinical, prodromal and dementia phases of Alzheimer's disease.
The Australian Imaging Biomarkers and Lifestyle Study (AIBL) is a multicenter
      multidisciplinary study of Alzheimer's disease and aging funded by the Commonwealth
      Scientific and Industrial Research Organisation (CSIRO) Flagship Initiative, involving
      research centers in both Victoria and Western Australia. The goal of the A08 protocol was to
      further investigate the positron emission tomography (PET) imaging results with flortaucipir
      in patients across the AD spectrum from individuals with subjective memory complaints (SMC)
      to those with dementia, based on recruitment into the parent AIBL study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Flortaucipir PET Imaging (Quantitative)
time frame: baseline scan
description: Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
measure: Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
time frame: baseline scan
description: Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.
measure: Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
time frame: baseline scan
description: Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.
arm group label: Alzheimer's disease (AD)
arm group type: Experimental
description: Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
arm group label: Mild cognitive impairment (MCI)
arm group type: Experimental
description: Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
arm group label: Subjective memory complainers (SMC)
arm group type: Experimental
description: Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
arm group label: Cognitively normal (CN)
arm group type: Experimental
description: Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
intervention type: Drug
intervention name: Flortaucipir F18
description: IV injection, 240 megabecquerel (MBq) (6.5 mCi)
arm group label: Alzheimer's disease (AD)
arm group label: Cognitively normal (CN)
arm group label: Mild cognitive impairment (MCI)
arm group label: Subjective memory complainers (SMC)
other name: 18F-AV-1451
other name: [F-18]T807
other name: LY3191748
other name: Tauvid
intervention type: Procedure
intervention name: Brain PET scan
description: positron emission tomography (PET) scan of the brain
arm group label: Alzheimer's disease (AD)
arm group label: Cognitively normal (CN)
arm group label: Mild cognitive impairment (MCI)
arm group label: Subjective memory complainers (SMC)
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chief Medical Officer
role: Study Director
affiliation: Avid Radiopharmaceuticals, Inc.
url: http://aibl.csiro.au/
description: Link to the Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL) website
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Cognitive Dysfunction
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 