<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/NCT04482660</url>
  </required_header>
  <id_info>
    <org_study_id>tau-PET/BBRC2019</org_study_id>
    <nct_id>NCT04482660</nct_id>
  </id_info>
  <brief_title>Characterization of Cerebral Tau Aggregates With 18F-RO6958948 PET in the ALFA Population</brief_title>
  <official_title>Characterization of Cerebral Tau Aggregates With 18F-RO6958948 PET in the ALFA Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barcelonabeta Brain Research Center, Pasqual Maragall Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Barcelonabeta Brain Research Center, Pasqual Maragall Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will characterize tau tracer retention by Positron Emission Tomography (PET) as a&#xD;
      function of amyloid levels transversally and longitudinally.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CROSS-SECTIONAL OBJECTIVES&#xD;
&#xD;
        -  To measure 18F-RO6958948 retention in selected participants of ALFA-related studies as a&#xD;
           function of amyloid levels.&#xD;
&#xD;
        -  To study the relation between 18F-RO6958948 retention and amyloid levels.&#xD;
&#xD;
        -  To characterize imaging correlates as a function of tau and amyloid levels.&#xD;
&#xD;
        -  To study the role of tau retention on cognitive performance.&#xD;
&#xD;
        -  To define predictors of tau retention.&#xD;
&#xD;
      LONGITUDINAL OBJECTIVES&#xD;
&#xD;
        -  To measure tau accumulation and spreading in participants of the ALFA-related studies of&#xD;
           BBRC as a function of baseline amyloid levels.&#xD;
&#xD;
        -  To study the dynamic relation between tau spreading and amyloid levels longitudinally.&#xD;
&#xD;
        -  To define predictors of tau spreading.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">March 29, 2021</start_date>
  <completion_date type="Anticipated">March 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of cerebral tau positivity</measure>
    <time_frame>at inclusion</time_frame>
    <description>Prevalence of cerebral tau positivity assessed by 18F-RO6958948 PET</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tau accumulation and spreading</measure>
    <time_frame>2 years</time_frame>
    <description>To predictors of tau spreading</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Healthy</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>PET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron emission tomography with 18F-RO6958948</intervention_name>
    <description>tau PET ()</description>
    <arm_group_label>PET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. To sign the study informed consent form approved by the corresponding authorities.&#xD;
&#xD;
          2. Men and women that have participated in a BBRC-sponsored study, including the ALFA&#xD;
             project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the ALFA&#xD;
             cognition study (ALFAcognition/BBRC2017) or the BarcelonaBeta Dementia Prevention&#xD;
             Research Clinic study (BBRC-DemPrev-2018).&#xD;
&#xD;
          3. Participants with an available cerebral MRI within the last 12 months not suggestive&#xD;
             of radiological incidental findings constituting an exclusion criterion.&#xD;
&#xD;
          4. Known cognitive status based on the cognitive workup of the BBRC-sponsored studies&#xD;
             specified above. Cognitive status should have been determined within the last 12&#xD;
             months.&#xD;
&#xD;
          5. Known AB and tau status.&#xD;
&#xD;
          6. Good knowledge of the language and being literate.&#xD;
&#xD;
          7. Female participants should be post-menopausal or present a negative pregnancy test at&#xD;
             the moment of PET acquisition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of clinically relevant psychiatric disorder according to the Diagnostic and&#xD;
             Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria: major depressive&#xD;
             disorder, generalized anxiety disorder, schizophrenia and bipolar disorder, as&#xD;
             assessed in the BBRC-sponsored studies specified above.&#xD;
&#xD;
          2. Participants with visual and/or hearing impairment.&#xD;
&#xD;
          3. History of encephalitis, ictus or seizures excluding feverish convulsions during&#xD;
             childhood, as assessed in the BBRC-sponsored studies specified above.&#xD;
&#xD;
          4. Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour&#xD;
             (metastasis/brain cancer) as verified by MRI.&#xD;
&#xD;
          5. Previous participation in a clinical study involving an investigational pharmaceutical&#xD;
             product within 30 days prior to screening and/or administration of a&#xD;
             radiopharmaceutical within 10 radioactive half-lives prior to study drug&#xD;
             administration in this study.&#xD;
&#xD;
          6. Clinically relevant renal or hepatic insufficiency.&#xD;
&#xD;
          7. Any other clinically important condition that may jeopardize the study or be dangerous&#xD;
             for the participant.&#xD;
&#xD;
          8. Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified&#xD;
             above.&#xD;
&#xD;
          9. Previous intolerance to PET studies or known hypersensitivity to 18F-RO6958948.&#xD;
&#xD;
         10. Being pregnant or breast-feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>BarcelonaBeta Brain Research Center</name>
      <address>
        <city>Barcelona</city>
        <zip>08005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</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>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04482660
org study id: tau-PET/BBRC2019
nct id: NCT04482660
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will characterize tau tracer retention by Positron Emission Tomography (PET) as a
      function of amyloid levels transversally and longitudinally.
CROSS-SECTIONAL OBJECTIVES

        -  To measure 18F-RO6958948 retention in selected participants of ALFA-related studies as a
           function of amyloid levels.

        -  To study the relation between 18F-RO6958948 retention and amyloid levels.

        -  To characterize imaging correlates as a function of tau and amyloid levels.

        -  To study the role of tau retention on cognitive performance.

        -  To define predictors of tau retention.

      LONGITUDINAL OBJECTIVES

        -  To measure tau accumulation and spreading in participants of the ALFA-related studies of
           BBRC as a function of baseline amyloid levels.

        -  To study the dynamic relation between tau spreading and amyloid levels longitudinally.

        -  To define predictors of tau spreading.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Prevalence of cerebral tau positivity
time frame: at inclusion
description: Prevalence of cerebral tau positivity assessed by 18F-RO6958948 PET
measure: tau accumulation and spreading
time frame: 2 years
description: To predictors of tau spreading
arm group label: PET
arm group type: Experimental
intervention type: Procedure
intervention name: Positron emission tomography with 18F-RO6958948
description: tau PET ()
arm group label: PET
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No