<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/NCT03824197</url>
  </required_header>
  <id_info>
    <org_study_id>18-446 MR 1901</org_study_id>
    <nct_id>NCT03824197</nct_id>
  </id_info>
  <brief_title>Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD)</brief_title>
  <acronym>(AU-ROOAD)</acronym>
  <official_title>Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Auburn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Auburn University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Until now there is no medical treatment and/or intervention that can slow, stop or reverse&#xD;
      the underlying neurodegenerative of Alzheimer's disease (AD). The goal of this study is to&#xD;
      demonstrate &quot;Oleocanthal rich-extra-virgin olive oil (EVOO) consumption stops or delay mild&#xD;
      cognitive impairment conversion to AD by restoring the blood-brain barrier (BBB) function in&#xD;
      humans&quot;.&#xD;
&#xD;
      Specific Aims:&#xD;
&#xD;
        1. Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB&#xD;
           function by dynamic contrast-enhanced MRI (DCE-MRI).&#xD;
&#xD;
        2. Evaluate effect of EVOO on cognitive function and on selected biomarkers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of olive oil on the BBB intactness</measure>
    <time_frame>6 months</time_frame>
    <description>Will be evaluated by DCE-MRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of olive oil on the brain activity</measure>
    <time_frame>6 months</time_frame>
    <description>Will be evaluated by fMRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>6 months</time_frame>
    <description>A battery of cognitive tasks to assess memory</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Cerebral Amyloid Angiopathy</condition>
  <arm_group>
    <arm_group_label>EVOO-phenol high</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OO-phenol low</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Olive oil with low phenolic content that will be added to daily diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EVOO</intervention_name>
    <description>Extra-virgin olive oil that is rich with oleocanthal and other phenols.</description>
    <arm_group_label>EVOO-phenol high</arm_group_label>
    <other_name>OC-rich EVOO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OO</intervention_name>
    <description>Olive oil low in oleocanthal and other phenols.</description>
    <arm_group_label>OO-phenol low</arm_group_label>
    <other_name>Olive oil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Men and women, experiencing mild cognitive impairment with:&#xD;
&#xD;
          1. Mini-Mental State Exam (MMSE) scores between 18-30 (based on education level&#xD;
&#xD;
          2. memory complaint, have objective memory loss measured by education adjusted scores on&#xD;
             Wechsler Memory Scale Logical Memory VI&#xD;
&#xD;
          3. Clinical Dementia Rating (CDR) score 0.5.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with contradictions for MRI include: the presence of metal or electronic&#xD;
             devices such as metallic joint prostheses, artificial heart valves, an implantable&#xD;
             heart defibrillator, a pacemaker, metal clips, cochlear implants, a bullet, shrapnel&#xD;
             or any other type of metal fragment; breathing problems or disorders, claustrophobia,&#xD;
             inner ear disorders, vertigo or dizziness, tattoos or permanent makeup that contains&#xD;
             metal, and body piercing jewelry that cannot be removed.&#xD;
&#xD;
          2. Subjects will be excluded if they are smokers&#xD;
&#xD;
          3. Subjects who have have clinically important medical or neuropsychiatric comorbidity.&#xD;
&#xD;
          4. Subjects who have renal problems or are allergic to the MRI contrast agent.&#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>Amal Kaddoumi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Auburn University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Auburn University</name>
      <address>
        <city>Auburn</city>
        <state>Alabama</state>
        <zip>36849</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Auburn University</investigator_affiliation>
    <investigator_full_name>Amal Kaddoumi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Cerebral Amyloid Angiopathy</mesh_term>
    <mesh_term>Cerebral Amyloid Angiopathy, Familial</mesh_term>
  </condition_browse>
  <!-- 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/NCT03824197
org study id: 18-446 MR 1901
nct id: NCT03824197
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Until now there is no medical treatment and/or intervention that can slow, stop or reverse
      the underlying neurodegenerative of Alzheimer's disease (AD). The goal of this study is to
      demonstrate "Oleocanthal rich-extra-virgin olive oil (EVOO) consumption stops or delay mild
      cognitive impairment conversion to AD by restoring the blood-brain barrier (BBB) function in
      humans".

      Specific Aims:

        1. Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB
           function by dynamic contrast-enhanced MRI (DCE-MRI).

        2. Evaluate effect of EVOO on cognitive function and on selected biomarkers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Effect of olive oil on the BBB intactness
time frame: 6 months
description: Will be evaluated by DCE-MRI
measure: Effect of olive oil on the brain activity
time frame: 6 months
description: Will be evaluated by fMRI
measure: Cognitive function
time frame: 6 months
description: A battery of cognitive tasks to assess memory
arm group label: EVOO-phenol high
arm group type: Other
description: Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet
arm group label: OO-phenol low
arm group type: Other
description: Olive oil with low phenolic content that will be added to daily diet
intervention type: Other
intervention name: EVOO
description: Extra-virgin olive oil that is rich with oleocanthal and other phenols.
arm group label: EVOO-phenol high
other name: OC-rich EVOO
intervention type: Other
intervention name: OO
description: Olive oil low in oleocanthal and other phenols.
arm group label: OO-phenol low
other name: Olive oil
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: No
last name: Amal Kaddoumi, PhD
role: Principal Investigator
affiliation: Auburn University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Auburn University
investigator full name: Amal Kaddoumi
investigator title: Professor
mesh term: Alzheimer Disease
mesh term: Cerebral Amyloid Angiopathy
mesh term: Cerebral Amyloid Angiopathy, Familial