<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/NCT03022968</url>
  </required_header>
  <id_info>
    <org_study_id>PHAO14-CH/TEPTAU</org_study_id>
    <nct_id>NCT03022968</nct_id>
  </id_info>
  <brief_title>Tau Brain Imaging in Typical and Atypical Alzheimer's Disease (AD)</brief_title>
  <acronym>TEPTAU</acronym>
  <official_title>Tau Brain Imaging in Typical and Atypical Alzheimer's Disease (AD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Recently revised Alzheimer Disease (AD) diagnostic1described nonamnestic presentations: 1/&#xD;
      language presentation (logopenic progressive aphasia) 2/ visuospatial presentation (posterior&#xD;
      cortical atrophy or PCA) and 3/ executive dysfunction. AD pathological changes may precede&#xD;
      the clinical diagnosis of dementia of AD type for a while2. Biomarkers have been developed:&#xD;
      biomarkers of brain amyloid-beta (Aß) (CerebroSpinal Fluid CSF concentration ßamyloid,&#xD;
      molecular imaging with amyloid targeted PET ligands), biomarkers of neural degeneration (MRI&#xD;
      hippocampal volume, regional metabolism as assessed by PET with [18F]-FDG) and may be used to&#xD;
      made early detection of the neuropathology associated with AD Even if CSF biomarkers (tau,&#xD;
      p-tau and β amyloïd are interesting to improve diagnosis of AD, they cannot provide&#xD;
      topographic information. PET tau imaging seems to be promise to evaluate quantitative and&#xD;
      spatial assessment of tau lesions both in AD and fronto-temporal lobar dementia.&#xD;
&#xD;
      The hypothesis of the research is that it exists a different regional pattern of tracer&#xD;
      retention across brain regions according to clinical symptoms : temporal for logopenic&#xD;
      aphasia and occipital for posterior cortical atrophy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Actual">November 25, 2019</completion_date>
  <primary_completion_date type="Actual">August 27, 2019</primary_completion_date>
  <phase>Phase 2</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>Tau density on PET imaging</measure>
    <time_frame>3 months</time_frame>
    <description>density pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tau distribution on PET imaging</measure>
    <time_frame>3 months</time_frame>
    <description>distribution pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>p-tau CSF biomarkers</measure>
    <time_frame>inclusion</time_frame>
    <description>p-tau dosing in pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>βamyloid CSF biomarkers</measure>
    <time_frame>inclusion</time_frame>
    <description>βamyloid dosing in pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive profile with Hamilton depression scale (MADRS)</measure>
    <time_frame>inclusion</time_frame>
    <description>neuropsychological score of Hamilton depression scale (MADRS) on 30 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive profile with Mini mental state evaluation (MMSE)</measure>
    <time_frame>inclusion</time_frame>
    <description>neuropsychological score of Mini mental state evaluation (MMSE) on 60 points</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Benson's Disease</condition>
  <arm_group>
    <arm_group_label>Alzheimer disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[18F]T807 PET</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benson disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[18F]T807 PET</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[18F]T807 PET</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[18F]T807 PET</intervention_name>
    <description>Imaging with [18F]T807 PET</description>
    <arm_group_label>Alzheimer disease</arm_group_label>
    <arm_group_label>Benson disease</arm_group_label>
    <arm_group_label>Healthy volunteer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 years old and more&#xD;
&#xD;
          -  native langage: french&#xD;
&#xD;
          -  study level upper (or equal) than 7 year (considering first year of grammar-school as&#xD;
             start)&#xD;
&#xD;
          -  correct sensory abilities (auditive device allowed) for tests&#xD;
&#xD;
          -  affiliation to social security&#xD;
&#xD;
          -  Informed, written consent form&#xD;
&#xD;
          -  for Alzheimer disease group: people with Alzheimer Disease defined as National&#xD;
             Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the&#xD;
             Alzheimer's Disease and Related Disorders Association (ADRDA) standards: Light to mild&#xD;
             AD defined by Mini-Mental State Examination (MMSE) score between 15 and 25 (included)&#xD;
&#xD;
          -  for Benson disease group: Benson disease following Mendez et al (2002) and Tang Wai et&#xD;
             al (2004) criteria&#xD;
&#xD;
          -  for healthy volunteer group: normal MMS score (more than 26 for bachelor level)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of disease with consequances on cognitive functioning (tumor, stroke, head&#xD;
             trauma, etc.), cerebral surgery&#xD;
&#xD;
          -  use of alchohol and/or drug&#xD;
&#xD;
          -  anormalies in neurological exam (focal deficit) not included in the classic symptoms&#xD;
&#xD;
          -  contraindication to magnetic resonance imaging (RMI)&#xD;
&#xD;
          -  contraindication to PET: people with prolongation of QT interval or taking medication&#xD;
             that can lead to &quot;torsades de pointe&quot;.&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  person with legal protection&#xD;
&#xD;
          -  exclusion period because of participation to another experimental protocol and actual&#xD;
             participation to an experimental protocol&#xD;
&#xD;
          -  pregnant or lactating woman or able to procreate and without contraception&#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>
  <location>
    <facility>
      <name>University Hospital of Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 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>Alzheimer Disease</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/NCT03022968
org study id: PHAO14-CH/TEPTAU
nct id: NCT03022968
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Recently revised Alzheimer Disease (AD) diagnostic1described nonamnestic presentations: 1/
      language presentation (logopenic progressive aphasia) 2/ visuospatial presentation (posterior
      cortical atrophy or PCA) and 3/ executive dysfunction. AD pathological changes may precede
      the clinical diagnosis of dementia of AD type for a while2. Biomarkers have been developed:
      biomarkers of brain amyloid-beta (Aß) (CerebroSpinal Fluid CSF concentration ßamyloid,
      molecular imaging with amyloid targeted PET ligands), biomarkers of neural degeneration (MRI
      hippocampal volume, regional metabolism as assessed by PET with [18F]-FDG) and may be used to
      made early detection of the neuropathology associated with AD Even if CSF biomarkers (tau,
      p-tau and β amyloïd are interesting to improve diagnosis of AD, they cannot provide
      topographic information. PET tau imaging seems to be promise to evaluate quantitative and
      spatial assessment of tau lesions both in AD and fronto-temporal lobar dementia.

      The hypothesis of the research is that it exists a different regional pattern of tracer
      retention across brain regions according to clinical symptoms : temporal for logopenic
      aphasia and occipital for posterior cortical atrophy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Tau density on PET imaging
time frame: 3 months
description: density pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)
measure: Tau distribution on PET imaging
time frame: 3 months
description: distribution pattern of aggregated tau using tau targeting PET imaging with [18F]-T807, in Standardized uptake value (SUV)
measure: p-tau CSF biomarkers
time frame: inclusion
description: p-tau dosing in pg/mL
measure: βamyloid CSF biomarkers
time frame: inclusion
description: βamyloid dosing in pg/mL
measure: Cognitive profile with Hamilton depression scale (MADRS)
time frame: inclusion
description: neuropsychological score of Hamilton depression scale (MADRS) on 30 points.
measure: Cognitive profile with Mini mental state evaluation (MMSE)
time frame: inclusion
description: neuropsychological score of Mini mental state evaluation (MMSE) on 60 points
arm group label: Alzheimer disease
arm group type: Experimental
description: [18F]T807 PET
arm group label: Benson disease
arm group type: Experimental
description: [18F]T807 PET
arm group label: Healthy volunteer
arm group type: Experimental
description: [18F]T807 PET
intervention type: Drug
intervention name: [18F]T807 PET
description: Imaging with [18F]T807 PET
arm group label: Alzheimer disease
arm group label: Benson disease
arm group label: Healthy volunteer
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: No