<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/NCT03024944</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR1419</org_study_id>
    <secondary_id>3R01AG050440</secondary_id>
    <nct_id>NCT03024944</nct_id>
  </id_info>
  <brief_title>TAU PET Imaging in Northern Manhattan Study of Metabolism and Mind</brief_title>
  <acronym>TAUPET</acronym>
  <official_title>TAU PET Imaging in Northern Manhattan Study of Metabolism and Mind</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to study brain imaging of a substance called tau, which is&#xD;
      found in brains of persons with Alzheimer's disease, using the Tau binder, 18F-THK-5351, for&#xD;
      live imaging of tau in the brain. The main goal of this proposal is to study whether diabetes&#xD;
      status (type 2 diabetes [referred to as diabetes] and pre-diabetes, compared with normal&#xD;
      glucose tolerance [NGT]), is associated with increased tau accumulation in the brain, one of&#xD;
      the culprits of Alzheimer's disease, in a community-based group of middle aged&#xD;
      Caribbean-Hispanics with a mean age of 63 years. The investigators propose to conduct tau&#xD;
      positron emission tomography (PET) imaging in 30 middle aged Hispanics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The burden of late onset Alzheimer's dementia (LOAD) and its antecedents is increasing&#xD;
      without known prevention or cure, and diabetes seems to be one of the strongest risk factors.&#xD;
      The predominating causal model in Alzheimer's disease (AD) research is based on the amyloid&#xD;
      hypothesis, which posits that amyloid (A) deposition in the brain causes synaptic dysfunction&#xD;
      resulting in early memory deficits and progression to mild cognitive impairment (MCI) and&#xD;
      dementia. Tau has also gained increasing interest as an AD pathology feature, biomarker, and&#xD;
      treatment target.&#xD;
&#xD;
      There are no known curative or preventive measures for LOAD. One of the strongest potential&#xD;
      LOAD risk factors is type 2 diabetes, an abnormal elevation of blood glucose associated with&#xD;
      microvascular and macrovascular complications including cerebrovascular disease. Many studies&#xD;
      have reported an association of diabetes with dementia, including LOAD and vascular dementia&#xD;
      (VD). Most studies have found that diabetes is associated with an increased risk of both LOAD&#xD;
      and VD, with a stronger association for VD compared with LOAD. Thus, this study focuses on&#xD;
      the relation of diabetes, pre-diabetes, and elevated glucose, with AD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    18F-THK5351 was reported non-specific binding of MAO receptors.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of Tau Accumulation by Measuring Standardized Uptake Value Ratio (SUVR)</measure>
    <time_frame>2 Years</time_frame>
    <description>The primary aim is to measure 18THK-5351 binding (SUVR) in medial temporal and inferior temporal cortex, cross-sectionally and longitudinally.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Alzheimer Dementia</condition>
  <arm_group>
    <arm_group_label>Brain Imaging with 18F-THK-5351</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group consists of 30 adult subjects: 10 with Type 2 diabetes, 10 with pre-diabetes, and 10 with normal glucose tolerance. Each subject will receive a baseline scan and a follow-up PET scan with 18F-THK-5351.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-THK-5351</intervention_name>
    <description>Intravenous (IV) catheter (tube) placed in participant arm. A small amount of 18F-THK-5351 will be injected into the IV enough time has passed for this contrast to collect in the tissue in the brain (approximately one half-hour), and participant will lie on a bed which slides into a PET Scanner to complete Tau imaging.</description>
    <arm_group_label>Brain Imaging with 18F-THK-5351</arm_group_label>
    <other_name>THK</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All persons who have undergone magnetic resonance imaging (MRI) and amyloid PET&#xD;
             already, or those who prospectively are deemed eligible for the parent study covered&#xD;
             under protocol AAAQ2950, will be approached for participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person who are not participating in the MRI and amyloid PET under protocol AAAQ2950&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose A Luchsinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>December 27, 2017</last_update_submitted>
  <last_update_submitted_qc>December 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>José A. Luchsinger</investigator_full_name>
    <investigator_title>Associate Professor of Medicine and Epidemiology</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>Dementia</keyword>
  <keyword>THK</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03024944
org study id: AAAR1419
secondary id: 3R01AG050440
nct id: NCT03024944
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this project is to study brain imaging of a substance called tau, which is
      found in brains of persons with Alzheimer's disease, using the Tau binder, 18F-THK-5351, for
      live imaging of tau in the brain. The main goal of this proposal is to study whether diabetes
      status (type 2 diabetes [referred to as diabetes] and pre-diabetes, compared with normal
      glucose tolerance [NGT]), is associated with increased tau accumulation in the brain, one of
      the culprits of Alzheimer's disease, in a community-based group of middle aged
      Caribbean-Hispanics with a mean age of 63 years. The investigators propose to conduct tau
      positron emission tomography (PET) imaging in 30 middle aged Hispanics.
The burden of late onset Alzheimer's dementia (LOAD) and its antecedents is increasing
      without known prevention or cure, and diabetes seems to be one of the strongest risk factors.
      The predominating causal model in Alzheimer's disease (AD) research is based on the amyloid
      hypothesis, which posits that amyloid (A) deposition in the brain causes synaptic dysfunction
      resulting in early memory deficits and progression to mild cognitive impairment (MCI) and
      dementia. Tau has also gained increasing interest as an AD pathology feature, biomarker, and
      treatment target.

      There are no known curative or preventive measures for LOAD. One of the strongest potential
      LOAD risk factors is type 2 diabetes, an abnormal elevation of blood glucose associated with
      microvascular and macrovascular complications including cerebrovascular disease. Many studies
      have reported an association of diabetes with dementia, including LOAD and vascular dementia
      (VD). Most studies have found that diabetes is associated with an increased risk of both LOAD
      and VD, with a stronger association for VD compared with LOAD. Thus, this study focuses on
      the relation of diabetes, pre-diabetes, and elevated glucose, with AD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Amount of Tau Accumulation by Measuring Standardized Uptake Value Ratio (SUVR)
time frame: 2 Years
description: The primary aim is to measure 18THK-5351 binding (SUVR) in medial temporal and inferior temporal cortex, cross-sectionally and longitudinally.
arm group label: Brain Imaging with 18F-THK-5351
arm group type: Experimental
description: This group consists of 30 adult subjects: 10 with Type 2 diabetes, 10 with pre-diabetes, and 10 with normal glucose tolerance. Each subject will receive a baseline scan and a follow-up PET scan with 18F-THK-5351.
intervention type: Drug
intervention name: 18F-THK-5351
description: Intravenous (IV) catheter (tube) placed in participant arm. A small amount of 18F-THK-5351 will be injected into the IV enough time has passed for this contrast to collect in the tissue in the brain (approximately one half-hour), and participant will lie on a bed which slides into a PET Scanner to complete Tau imaging.
arm group label: Brain Imaging with 18F-THK-5351
other name: THK
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jose A Luchsinger, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: José A. Luchsinger
investigator title: Associate Professor of Medicine and Epidemiology
mesh term: Dementia
mesh term: Alzheimer Disease
mesh term: Diabetes Mellitus
sharing ipd: Undecided