<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/NCT03761381</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#00017045</org_study_id>
    <nct_id>NCT03761381</nct_id>
  </id_info>
  <brief_title>OCT Angiography and NRAI in Dementia</brief_title>
  <official_title>Using Optical Coherence Tomography and Noninvasive Retinal Amyloid Imaging to Capture Retinal Changes Associated With Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</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>
      The primary goals of this study are to use optical coherence tomography (OCT) angiography&#xD;
      (blood vessel mapping) to:&#xD;
&#xD;
        1. Detect retinal blood vessel and blood flow changes in participants with dementia.&#xD;
&#xD;
        2. Detect amyloid protein deposits in the retinas of participants with dementia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 14, 2018</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Retinal amyloid protein detection</measure>
    <time_frame>1 day</time_frame>
    <description>OCT and OCT angiography will be used to detect levels of amyloid proteins deposits within the retina layers on the single enrollment visit only. An increase in the protein detection is expected in the dementia group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decreased blood flow</measure>
    <time_frame>1 day</time_frame>
    <description>OCT and OCT angiography will be used to detect blood flow in dementia vs dementia-free controls. OCT and OCTA imaging will be taken on the single enrollment visit only. Decreased blood flow is expected in the dementia group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decreased retinal perfusion</measure>
    <time_frame>1 day</time_frame>
    <description>OCT and OCT angiography will be used to detect retinal perfusion deficits in dementia vs dementia-free controls. OCT and OCTA imaging will be taken on a single enrollment visit only. Decreased retinal perfusion is expected in the dementia group.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Dementia</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Early Dementia</arm_group_label>
    <description>This group will consist of adults with suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dementia-Free Controls</arm_group_label>
    <description>This group will consist of adults without suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optical Coherence Tomography Angiography (OCTA) Imaging</intervention_name>
    <description>Optical coherence tomography is a non-invasive imaging technology that provides cross-sectional images of tissues in micron-scale resolution. The angiography component of this device allows for evaluation of blood vessel and blood flow changes in the eye. The Solix device with AngioVue software will be used to detect these blood vessel and flow changes as well as protein deposits in the retinal layers.</description>
    <arm_group_label>Dementia-Free Controls</arm_group_label>
    <arm_group_label>Early Dementia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noninvasive Retinal Amyloid Imaging (NRAI)</intervention_name>
    <description>The Spectralis will be used for NRAI. This system uses a special light source and optical filters to detect fluorescence of amyloid proteins in the eye.</description>
    <arm_group_label>Dementia-Free Controls</arm_group_label>
    <arm_group_label>Early Dementia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Dementia subjects will be recruited from the Layton Aging &amp; Alzheimer's Disease Clinic at&#xD;
        Oregon Health &amp; Science University. Dementia-free subjects will be recruited from those&#xD;
        currently being followed in the Layton Aging &amp; Alzheimer's Disease Center longitudinal&#xD;
        aging study with MRI and amyloid PET imaging.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for dementia subjects:&#xD;
&#xD;
          -  Physician-confirmed diagnosis of probable Alzheimer's disease&#xD;
&#xD;
          -  Mild dementia, as defined by score of 20 or greater on the Mini-Mental State Exam, or&#xD;
             score of 15 or greater on the Montreal Cognitive Assessment, or Clinical Dementia&#xD;
             Rating Scale score of 1.&#xD;
&#xD;
          -  Age older than 55 years.&#xD;
&#xD;
          -  Able to comply with study procedures&#xD;
&#xD;
          -  Corrected visual acuity at least 20/400 in either eye.&#xD;
&#xD;
          -  Has a legally authorized representative who can sign study consent form and accompany&#xD;
             the participant to the OCT study visit.&#xD;
&#xD;
        Inclusion Criteria for dementia-free controls:&#xD;
&#xD;
          -  Age older than 55 years&#xD;
&#xD;
          -  Able to comply with study procedures&#xD;
&#xD;
          -  Able to maintain stable fixation for OCT imaging&#xD;
&#xD;
          -  Corrected visual acuity of at least 20/40 in either eye&#xD;
&#xD;
          -  Dementia-free, as defined by score of 24 or greater on the Mini-Mental Status Exam, or&#xD;
             a score of 18 or greater on the Montreal Cognitive Assessment, or Clinical Dementia&#xD;
             Rating of &lt;1.0.&#xD;
&#xD;
        Exclusion Criteria for both dementia and dementia-free subjects:&#xD;
&#xD;
          -  Non-Alzheimer's disease related primary neurologic disease affecting the central&#xD;
             nervous system (i.e. multiple sclerosis, Parkinson's disease)&#xD;
&#xD;
          -  Evidence on ophthalmological exam within the last year of other ocular diseases or&#xD;
             pathology that would confound the assessment of dementia (e.g. glaucoma, diabetic or&#xD;
             hypertensive retinal disease, amblyopia, etc.)&#xD;
&#xD;
          -  Media opacity such as cataract, corneal scar, or vitreous opacity that could interfere&#xD;
             with retinal imaging.&#xD;
&#xD;
          -  Previous intraocular surgery except for uncomplicated cataract extraction with&#xD;
             posterior chamber intraocular lens implantation&#xD;
&#xD;
          -  Inability to maintain stable fixation for OCT imaging or provide informed consent&#xD;
&#xD;
          -  Spherical equivalent refractive error greater than +3 or -7 diopters, or astigmatism&#xD;
             magnitude of greater than 2 diopters.&#xD;
&#xD;
          -  Diabetes for more than 10 years or hemoglobin A1C level of &gt; 10 within the 180 days&#xD;
             prior to OCT scanning.&#xD;
&#xD;
          -  Uncontrolled hypertension. : SBP &gt; 170 or DBP &gt; 100&#xD;
&#xD;
          -  Arrhythmia: irregular pulse, or heart rate not between 50 and 110 beats per minute&#xD;
&#xD;
          -  Pregnancy or breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Huang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Denzil Romfh, OD</last_name>
    <phone>503-494-4351</phone>
    <email>romfhd@ohsu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Humberto Martinez, COT</last_name>
    <phone>503-494-7712</phone>
    <email>martinhu@ohsu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denzil Romfh, OD</last_name>
      <phone>503-494-4351</phone>
      <email>romfhd@ohsu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Humberto Martinez, COT</last_name>
      <phone>503-494-7712</phone>
      <email>martinhu@ohsu.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 2, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>September 22, 2022</last_update_submitted>
  <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>David Huang</investigator_full_name>
    <investigator_title>David Huang, MD, PhD, Peterson Professor of Ophthalmology and Professor orf Biomedical Engineering</investigator_title>
  </responsible_party>
  <keyword>MCI</keyword>
  <keyword>OCT</keyword>
  <keyword>Angiography</keyword>
  <keyword>Alzheimer's</keyword>
  <keyword>Dementia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT03761381
org study id: IRB#00017045
nct id: NCT03761381
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The primary goals of this study are to use optical coherence tomography (OCT) angiography
      (blood vessel mapping) to:

        1. Detect retinal blood vessel and blood flow changes in participants with dementia.

        2. Detect amyloid protein deposits in the retinas of participants with dementia.
observational model: Case-Control
time perspective: Prospective
measure: Retinal amyloid protein detection
time frame: 1 day
description: OCT and OCT angiography will be used to detect levels of amyloid proteins deposits within the retina layers on the single enrollment visit only. An increase in the protein detection is expected in the dementia group.
measure: Decreased blood flow
time frame: 1 day
description: OCT and OCT angiography will be used to detect blood flow in dementia vs dementia-free controls. OCT and OCTA imaging will be taken on the single enrollment visit only. Decreased blood flow is expected in the dementia group.
measure: Decreased retinal perfusion
time frame: 1 day
description: OCT and OCT angiography will be used to detect retinal perfusion deficits in dementia vs dementia-free controls. OCT and OCTA imaging will be taken on a single enrollment visit only. Decreased retinal perfusion is expected in the dementia group.
arm group label: Early Dementia
description: This group will consist of adults with suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit.
arm group label: Dementia-Free Controls
description: This group will consist of adults without suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit.
intervention type: Device
intervention name: Optical Coherence Tomography Angiography (OCTA) Imaging
description: Optical coherence tomography is a non-invasive imaging technology that provides cross-sectional images of tissues in micron-scale resolution. The angiography component of this device allows for evaluation of blood vessel and blood flow changes in the eye. The Solix device with AngioVue software will be used to detect these blood vessel and flow changes as well as protein deposits in the retinal layers.
arm group label: Dementia-Free Controls
arm group label: Early Dementia
intervention type: Device
intervention name: Noninvasive Retinal Amyloid Imaging (NRAI)
description: The Spectralis will be used for NRAI. This system uses a special light source and optical filters to detect fluorescence of amyloid proteins in the eye.
arm group label: Dementia-Free Controls
arm group label: Early Dementia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Huang, MD, PhD
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: Denzil Romfh, OD
phone: 503-494-4351
email: romfhd@ohsu.edu
last name: Humberto Martinez, COT
phone: 503-494-7712
email: martinhu@ohsu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: David Huang
investigator title: David Huang, MD, PhD, Peterson Professor of Ophthalmology and Professor orf Biomedical Engineering
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Cognitive Dysfunction