<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/NCT03273335</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00083288</org_study_id>
    <secondary_id>1K76AG057022</secondary_id>
    <nct_id>NCT03273335</nct_id>
  </id_info>
  <brief_title>Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults</brief_title>
  <acronym>INTUIT</acronym>
  <official_title>Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke 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>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      (From NIH reporter) Each year &gt;16 million older Americans undergo anesthesia and surgery, and&#xD;
      up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of&#xD;
      postoperative thinking and memory deficits. Although distinct from delirium, POCD (like&#xD;
      delirium) is associated with decreased quality of life, long term cognitive decline, early&#xD;
      retirement, increased mortality, and a possible increased risk for developing dementia such&#xD;
      as Alzheimer's disease. Understanding the etiology of POCD will likely help promote&#xD;
      strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes&#xD;
      POCD, but little work has directly tested this theory in humans. The preliminary data of this&#xD;
      team strongly suggest that there is significant postoperative neuro-inflammation in older&#xD;
      adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre-&#xD;
      and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients&#xD;
      over age 65. This will allow the investigators to evaluate the role of specific&#xD;
      neuro-inflammatory processes in POCD and its underlying brain connectivity changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each year &gt;16 million older Americans undergo anesthesia and surgery, and up to 40% of these&#xD;
      patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative&#xD;
      thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is&#xD;
      associated with decreased quality of life, long term cognitive decline, early retirement,&#xD;
      increased mortality, and a possible increased risk for developing dementia such as&#xD;
      Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies&#xD;
      to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but&#xD;
      little work has directly tested this theory in humans. The preliminary data of this team&#xD;
      strongly suggest that there is significant postoperative neuro-inflammation in older adults&#xD;
      who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and&#xD;
      post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over&#xD;
      age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory&#xD;
      processes in POCD and its underlying brain connectivity changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Actual">October 21, 2022</completion_date>
  <primary_completion_date type="Actual">November 11, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between Perioperative changes in CSF Monocytes and perioperative changes in cognition (continuous cognitive index change)</measure>
    <time_frame>from before to 6 weeks after anesthesia/surgery</time_frame>
    <description>as above</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">201</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Surgical patients</arm_group_label>
    <description>Surgical patients will undergo CSF biomarker assays, cognitive testing and fMRI scans.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Millipore biomarker assay plate</intervention_name>
    <description>Millipore biomarker assay plate CSF cytokine assays as well as CSF flow cytometry</description>
    <arm_group_label>Surgical patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      CSF, Blood/Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Surgical patients age 60 and above, as described above.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 60 and above&#xD;
&#xD;
          -  Having surgery scheduled to last &gt; or = to 2 hours at Duke University Medical Center&#xD;
             (ie Duke Hospital, Duke Medicine Pavilion, Duke Regional Hospital, Durham VA, Duke&#xD;
             Raleigh Hospital)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anticoagulants (per ASRA guidelines)&#xD;
&#xD;
          -  Current use of chemotherapeutic agents with known cognitive effects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miles Berger, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>November 15, 2022</last_update_submitted>
  <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 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>Delirium</mesh_term>
    <mesh_term>Neuroinflammatory Diseases</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/NCT03273335
org study id: Pro00083288
secondary id: 1K76AG057022
nct id: NCT03273335
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
(From NIH reporter) Each year >16 million older Americans undergo anesthesia and surgery, and
      up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of
      postoperative thinking and memory deficits. Although distinct from delirium, POCD (like
      delirium) is associated with decreased quality of life, long term cognitive decline, early
      retirement, increased mortality, and a possible increased risk for developing dementia such
      as Alzheimer's disease. Understanding the etiology of POCD will likely help promote
      strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes
      POCD, but little work has directly tested this theory in humans. The preliminary data of this
      team strongly suggest that there is significant postoperative neuro-inflammation in older
      adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre-
      and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients
      over age 65. This will allow the investigators to evaluate the role of specific
      neuro-inflammatory processes in POCD and its underlying brain connectivity changes.
Each year >16 million older Americans undergo anesthesia and surgery, and up to 40% of these
      patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative
      thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is
      associated with decreased quality of life, long term cognitive decline, early retirement,
      increased mortality, and a possible increased risk for developing dementia such as
      Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies
      to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but
      little work has directly tested this theory in humans. The preliminary data of this team
      strongly suggest that there is significant postoperative neuro-inflammation in older adults
      who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and
      post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over
      age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory
      processes in POCD and its underlying brain connectivity changes.
observational model: Cohort
time perspective: Prospective
measure: Correlation between Perioperative changes in CSF Monocytes and perioperative changes in cognition (continuous cognitive index change)
time frame: from before to 6 weeks after anesthesia/surgery
description: as above
arm group label: Surgical patients
description: Surgical patients will undergo CSF biomarker assays, cognitive testing and fMRI scans.
intervention type: Device
intervention name: Millipore biomarker assay plate
description: Millipore biomarker assay plate CSF cytokine assays as well as CSF flow cytometry
arm group label: Surgical patients
CSF, Blood/Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 130 Years
healthy volunteers: No
last name: Miles Berger, MD, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Delirium
mesh term: Neuroinflammatory Diseases
sharing ipd: Undecided