<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/NCT02226835</url>
  </required_header>
  <id_info>
    <org_study_id>140173</org_study_id>
    <secondary_id>14-EI-0173</secondary_id>
    <nct_id>NCT02226835</nct_id>
  </id_info>
  <brief_title>Study of Retinal Findings in People With Signs and Symptoms of Alzheimer s Disease Enrolled in 09-M-0198</brief_title>
  <official_title>An Investigation of Retinal Findings in Patients With Signs and Symptoms of Alzheimer's Disease Enrolled in 09-M-0198</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Alzheimer s disease affects the brain and causes memory and thinking problems in older&#xD;
      people. Macular degeneration (MD) is an eye condition. It is the leading reason that people&#xD;
      over age 55 in the United States lose their central vision. Central vision is important for&#xD;
      seeing fine details and for tasks like reading and driving. A feature of Alzheimer s disease&#xD;
      is plaques in the brain. A feature of age-related MD is deposits in the retina in the eye.&#xD;
      Researchers want to learn more about these diseases and find out if they are related.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To see whether there is a relationship between Alzheimer s disease and age-related macular&#xD;
      degeneration.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - People with or without Alzheimer s disease enrolled in another study. Participants must&#xD;
      have someone to help them take part in this study.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened through the other study. They will have 1 visit. The tests&#xD;
           will take about 3 hours.&#xD;
&#xD;
        -  Participants will answer questions about their medical and eye history.&#xD;
&#xD;
        -  Participants will have an eye exam to test how well they see. Their eye pressure will be&#xD;
           measured and their eye movements will be checked.&#xD;
&#xD;
        -  Participants will get eye drops to dilate their pupils. Researchers will take pictures&#xD;
           of the retina and the inside of the eye. Researchers may measure the thickness of the&#xD;
           retina.&#xD;
&#xD;
        -  Participants will continue to receive care from their regular eye doctor during and&#xD;
           after the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective:&#xD;
&#xD;
      Age-related macular degeneration (AMD) and Alzheimer s disease (AD) are both&#xD;
      neurodegenerative diseases which affect a similar demographic of patients. Beyond age being a&#xD;
      common risk factor for both diseases, an important common characteristic is a similarity in&#xD;
      pathology findings, specifically, the presence of amyloid (beta) (A(beta)) in the senile&#xD;
      plaques of the AD brain and in the drusen of AMD patients. As both of these diseases are the&#xD;
      cause of significant morbidity of the quickly growing aging population, understanding the&#xD;
      pathogenesis of both and identification of any overlapping pathophysiology will lead to a&#xD;
      better understanding of each disease. The objective of this study is to investigate the&#xD;
      presence of AMD and other neurodegenerative lesions and characterize retinal findings in a&#xD;
      group of participants with well-phenotyped AD.&#xD;
&#xD;
      Study Population:&#xD;
&#xD;
      Up to 150 participants (100 symptomatic, 50 controls) will be recruited from patients already&#xD;
      enrolled and participating in the National Institute of Mental Health (NIMH) study,&#xD;
      09-M-0198, Screening and Evaluation of Patients with Signs and Symptoms of Alzheimer s&#xD;
      Disease.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      This is a single center, cross-sectional, observational study that will include a single eye&#xD;
      clinic visit with eye exam, visual acuity, photography and optical coherence tomography (OCT)&#xD;
      testing.&#xD;
&#xD;
      Outcome Measures:&#xD;
&#xD;
      The primary outcome is the presence of AMD or other retinal findings in patients diagnosed&#xD;
      with AD. Secondary outcomes will include autofluorescence imaging, spectral domain OCT and&#xD;
      visual acuity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>August 13, 2014</start_date>
  <completion_date type="Actual">January 24, 2017</completion_date>
  <primary_completion_date type="Actual">January 24, 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Photographs and images of subjects' eyes</measure>
    <time_frame>Study completion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>OCT measurement</measure>
    <time_frame>Study completion</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">33</enrollment>
  <condition>Age-Related Macular Degeneration</condition>
  <condition>Alzheiner's Disease</condition>
  <condition>AMD</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Patient must be enrolled in the 09-M-0198 protocol.&#xD;
&#xD;
          -  In those participants that require special assistance, we will request that they be&#xD;
             accompanied by a care taker to provide proper care and monitoring.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  The diagnosis of a different type of dementia, including frontotemporal dementia,&#xD;
             normal pressure hydrocephalus, Lewy body dementia, Parkinson s disease dementia,&#xD;
             Huntington s disease, or vascular dementia.&#xD;
&#xD;
          -  Any medical contraindication to the procedures performed in the study, or any current&#xD;
             severe medical or psychiatric illness other than Alzheimer s disease.&#xD;
&#xD;
          -  Behavioral symptoms that would preclude the gathering of data for the study, or&#xD;
             advanced disease such that participants cannot provide assent.&#xD;
&#xD;
        Controls:&#xD;
&#xD;
          -  The diagnosis of a brain disorder.&#xD;
&#xD;
          -  Any medical contraindication to the procedures performed in the study, or any current&#xD;
             severe medical or psychiatric illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine A Cukras, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Eye Institute (NEI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center, 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Friedman DS, O'Colmain BJ, Munoz B, Tomany SC, McCarty C, de Jong PT, Nemesure B, Mitchell P, Kempen J; Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004 Apr;122(4):564-72. doi: 10.1001/archopht.122.4.564. Erratum In: Arch Ophthalmol. 2011 Sep;129(9):1188.</citation>
    <PMID>15078675</PMID>
  </reference>
  <reference>
    <citation>Ferris FL 3rd, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthalmol. 1984 Nov;102(11):1640-2. doi: 10.1001/archopht.1984.01040031330019.</citation>
    <PMID>6208888</PMID>
  </reference>
  <reference>
    <citation>Hebert LE, Scherr PA, Bienias JL, Bennett DA, Evans DA. Alzheimer disease in the US population: prevalence estimates using the 2000 census. Arch Neurol. 2003 Aug;60(8):1119-22. doi: 10.1001/archneur.60.8.1119.</citation>
    <PMID>12925369</PMID>
  </reference>
  <verification_date>January 24, 2017</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>September 26, 2018</last_update_submitted>
  <last_update_submitted_qc>September 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OCT</keyword>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>Age-Related Macular Degeneration (AMD)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</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/NCT02226835
org study id: 140173
secondary id: 14-EI-0173
nct id: NCT02226835
lead sponsor: 
Background:

      - Alzheimer s disease affects the brain and causes memory and thinking problems in older
      people. Macular degeneration (MD) is an eye condition. It is the leading reason that people
      over age 55 in the United States lose their central vision. Central vision is important for
      seeing fine details and for tasks like reading and driving. A feature of Alzheimer s disease
      is plaques in the brain. A feature of age-related MD is deposits in the retina in the eye.
      Researchers want to learn more about these diseases and find out if they are related.

      Objective:

      - To see whether there is a relationship between Alzheimer s disease and age-related macular
      degeneration.

      Eligibility:

      - People with or without Alzheimer s disease enrolled in another study. Participants must
      have someone to help them take part in this study.

      Design:

        -  Participants will be screened through the other study. They will have 1 visit. The tests
           will take about 3 hours.

        -  Participants will answer questions about their medical and eye history.

        -  Participants will have an eye exam to test how well they see. Their eye pressure will be
           measured and their eye movements will be checked.

        -  Participants will get eye drops to dilate their pupils. Researchers will take pictures
           of the retina and the inside of the eye. Researchers may measure the thickness of the
           retina.

        -  Participants will continue to receive care from their regular eye doctor during and
           after the study.
Objective:

      Age-related macular degeneration (AMD) and Alzheimer s disease (AD) are both
      neurodegenerative diseases which affect a similar demographic of patients. Beyond age being a
      common risk factor for both diseases, an important common characteristic is a similarity in
      pathology findings, specifically, the presence of amyloid (beta) (A(beta)) in the senile
      plaques of the AD brain and in the drusen of AMD patients. As both of these diseases are the
      cause of significant morbidity of the quickly growing aging population, understanding the
      pathogenesis of both and identification of any overlapping pathophysiology will lead to a
      better understanding of each disease. The objective of this study is to investigate the
      presence of AMD and other neurodegenerative lesions and characterize retinal findings in a
      group of participants with well-phenotyped AD.

      Study Population:

      Up to 150 participants (100 symptomatic, 50 controls) will be recruited from patients already
      enrolled and participating in the National Institute of Mental Health (NIMH) study,
      09-M-0198, Screening and Evaluation of Patients with Signs and Symptoms of Alzheimer s
      Disease.

      Design:

      This is a single center, cross-sectional, observational study that will include a single eye
      clinic visit with eye exam, visual acuity, photography and optical coherence tomography (OCT)
      testing.

      Outcome Measures:

      The primary outcome is the presence of AMD or other retinal findings in patients diagnosed
      with AD. Secondary outcomes will include autofluorescence imaging, spectral domain OCT and
      visual acuity.
observational model: Cohort
time perspective: Cross-Sectional
measure: Photographs and images of subjects' eyes
time frame: Study completion
measure: OCT measurement
time frame: Study completion
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine A Cukras, M.D.
role: Principal Investigator
affiliation: National Eye Institute (NEI)
facility: 
country: United States
citation: Friedman DS, O'Colmain BJ, Munoz B, Tomany SC, McCarty C, de Jong PT, Nemesure B, Mitchell P, Kempen J; Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004 Apr;122(4):564-72. doi: 10.1001/archopht.122.4.564. Erratum In: Arch Ophthalmol. 2011 Sep;129(9):1188.
PMID: 15078675
citation: Ferris FL 3rd, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthalmol. 1984 Nov;102(11):1640-2. doi: 10.1001/archopht.1984.01040031330019.
PMID: 6208888
citation: Hebert LE, Scherr PA, Bienias JL, Bennett DA, Evans DA. Alzheimer disease in the US population: prevalence estimates using the 2000 census. Arch Neurol. 2003 Aug;60(8):1119-22. doi: 10.1001/archneur.60.8.1119.
PMID: 12925369
responsible party type: Sponsor
mesh term: Macular Degeneration