<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/NCT03777722</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 17-2685</org_study_id>
    <nct_id>NCT03777722</nct_id>
  </id_info>
  <brief_title>Light and the Effect on Metabolic Syndrome and Alzheimer's Disease</brief_title>
  <official_title>Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rutgers University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study's main hypothesis is that a delivering a tailored lighting intervention (TLI) will&#xD;
      provide a successful means for promoting circadian entrainment and treating metabolic disease&#xD;
      and inflammation in patients with mild cognitive impairment (MCI) and Alzheimer's disease&#xD;
      (AD) and Alzheimer's disease and related dementias (ADRD). As such, the proposed studies have&#xD;
      the potential to provide important insights into the link between AD/ADRD and type 2 diabetes&#xD;
      (T2DM) by identifying the disruption of circadian rhythms as a key component in the metabolic&#xD;
      impairment. Preliminary data from ongoing studies demonstrates a beneficial effect of light&#xD;
      treatment on sleep and depression. If positive results are observed, the potential also&#xD;
      exists to transform the manner in which homes, assisted living facilities, and nursing homes&#xD;
      are lighted by delivering a simple, practical, non-pharmacological intervention to promote&#xD;
      entrainment, improve sleep, and reduce metabolic disease in AD and mild AD MCI patients. This&#xD;
      randomized, placebo-controlled, crossover study involving 60 AD/ADRD patients who live in&#xD;
      controlled environments (i.e., assisted living facilities and nursing homes), will&#xD;
      investigate whether 8 weeks of exposure to a TLI designed to increase circadian entrainment&#xD;
      improves sleep, mood, inflammatory markers, and metabolic control, compared to a control,&#xD;
      circadian-inactive light.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alzheimer's disease (AD) and type 2 diabetes (T2DM) pose linked, major threats to aging&#xD;
      societies worldwide, but the relationship between these two diseases remains poorly&#xD;
      understood. Hence, insulin resistance may account for the close epidemiological association&#xD;
      between AD and T2DM. A major gap in the understanding of this association, however, is how&#xD;
      brain insulin resistance develops in the context of AD. Studies show that circadian&#xD;
      disruption impairs metabolic control and increases the risk for diabetes and obesity. Vice&#xD;
      versa, disrupted sleep and depression are closely linked to impaired metabolic control and&#xD;
      increased diabetes risk in the general population. Notably, AD is associated with circadian&#xD;
      disruption, which may be amplified by exposure to irregular light-dark patterns or constant&#xD;
      dim light. To what extent circadian disruption contributes to increased diabetes risk in AD&#xD;
      remains unclear. Here, the investigator aims to test whether a novel tailored lighting&#xD;
      intervention (TLI) designed to promote circadian entrainment in AD patients can improve&#xD;
      metabolic control. Preliminary data from ongoing studies demonstrates a beneficial effect of&#xD;
      light treatment on sleep and depression. Given the close association of sleep on metabolic&#xD;
      control, these data support the hypothesis that light therapy that promotes entrainment can&#xD;
      restore metabolic control in AD patients. Specifically, the investigator will test the&#xD;
      efficacy of a practical, scientifically sophisticated 24-hour lighting system for increasing&#xD;
      circadian entrainment in older adults with AD and related dementias (ADRD). The major goal is&#xD;
      to demonstrate that a practical, effective, tailored, nonpharmacological intervention that&#xD;
      promotes circadian entrainment can be used to improve sleep, reduce inflammation, and&#xD;
      ameliorate glucose intolerance and insulin resistance in AD/ADRD patients.&#xD;
&#xD;
      Aim 1: Test if a TLI that promotes entrainment can improve sleep, depression, inflammation,&#xD;
      and glucose tolerance in patients with moderate to late stages ADRD. In a randomized,&#xD;
      placebo-controlled, crossover study involving 60 ADRD patients who live in controlled&#xD;
      environments, the investigators will investigate whether an 8-week exposure to a TLI designed&#xD;
      to increase circadian entrainment (urinary melatonin and activity-rest patterns) will improve&#xD;
      inflammation and glucose tolerance (oral glucose tolerance test), and reduce sleep&#xD;
      disturbances (actigraphy, Pittsburgh Sleep Quality Index, PSQI) and depressive symptoms&#xD;
      (Cornell Scale for Depression in Dementia, CSDD) compared to a control, circadian-inactive&#xD;
      light.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Crossover placebo controlled design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Glucose tolerance</measure>
    <time_frame>once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26</time_frame>
    <description>change in glucose tolerance from baseline will be assessed using an oral glucose tolerance test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in sleep disturbance</measure>
    <time_frame>once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26</time_frame>
    <description>Change in sleep disturbance will be assessed using the Pittsburgh Sleep Quality Index. The sum of the 7 component scores yields a single global score. A person with a global score above 5 is considered to have sleep disturbances. A higher score indicates worsening sleep disturbance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in depression</measure>
    <time_frame>once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26</time_frame>
    <description>A change in depression will be assessed using the Cornell Scale for Depression in Dementia. A score of twelve or more points indicates depression. A higher score indicates worsening depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep Efficiency using actigraphy</measure>
    <time_frame>7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26</time_frame>
    <description>Actigraphs will be worn for 7 days during assessment weeks. Actigraphy will be used to calculate changes in sleep efficiency. A higher sleep efficiency indicates better sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Light exposure using the Daysimeter</measure>
    <time_frame>7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26</time_frame>
    <description>Daysimeters will be worn for 7 days during assessment periods to measure the amount of circadian effective light delivered by the lighting intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Aim 1: Active Intervention then Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tailored Lighting intervention (TLI). The active TLI will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. The active lighting intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the placebo control intervention for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aim 1: Placebo Intervention then Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The placebo lighting intervention is designed to have no effect on the circadian system. The control intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the active tailored lighting intervention for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tailored Lighting Intervention</intervention_name>
    <description>Lighting Intervention - active or placebo</description>
    <arm_group_label>Aim 1: Active Intervention then Placebo</arm_group_label>
    <arm_group_label>Aim 1: Placebo Intervention then Active</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of mild to moderate Alzheimer's disease or related dementia,&#xD;
&#xD;
          -  sleep disturbance as determined by a score ≥ 5 on the PSQI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  insulin-dependent diabetes,&#xD;
&#xD;
          -  urinary incontinence&#xD;
&#xD;
          -  obstructing cataracts&#xD;
&#xD;
          -  macular degeneration&#xD;
&#xD;
          -  blindness&#xD;
&#xD;
          -  severe sleep apnea or&#xD;
&#xD;
          -  restless leg syndrome (RLS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mariana Figueiro, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barbara Plitnick, BSN</last_name>
    <phone>518-242-4603</phone>
    <email>barbara.plitnick@mountsinai.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rutgers University</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08854</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Plitnick, BSN</last_name>
      <email>barbara.plitnick@mountsinai.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Plitnick, BSN</last_name>
      <phone>518-242-4603</phone>
      <email>barbara.plitnick@mountsinai.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Plitnick, BSN</last_name>
      <email>barbara.plitnick@mountsinai.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Mariana Figueiro</investigator_full_name>
    <investigator_title>Professor, Population Health Science and Policy</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>Metabolic Syndrome</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03777722
org study id: GCO 17-2685
nct id: NCT03777722
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study's main hypothesis is that a delivering a tailored lighting intervention (TLI) will
      provide a successful means for promoting circadian entrainment and treating metabolic disease
      and inflammation in patients with mild cognitive impairment (MCI) and Alzheimer's disease
      (AD) and Alzheimer's disease and related dementias (ADRD). As such, the proposed studies have
      the potential to provide important insights into the link between AD/ADRD and type 2 diabetes
      (T2DM) by identifying the disruption of circadian rhythms as a key component in the metabolic
      impairment. Preliminary data from ongoing studies demonstrates a beneficial effect of light
      treatment on sleep and depression. If positive results are observed, the potential also
      exists to transform the manner in which homes, assisted living facilities, and nursing homes
      are lighted by delivering a simple, practical, non-pharmacological intervention to promote
      entrainment, improve sleep, and reduce metabolic disease in AD and mild AD MCI patients. This
      randomized, placebo-controlled, crossover study involving 60 AD/ADRD patients who live in
      controlled environments (i.e., assisted living facilities and nursing homes), will
      investigate whether 8 weeks of exposure to a TLI designed to increase circadian entrainment
      improves sleep, mood, inflammatory markers, and metabolic control, compared to a control,
      circadian-inactive light.
Alzheimer's disease (AD) and type 2 diabetes (T2DM) pose linked, major threats to aging
      societies worldwide, but the relationship between these two diseases remains poorly
      understood. Hence, insulin resistance may account for the close epidemiological association
      between AD and T2DM. A major gap in the understanding of this association, however, is how
      brain insulin resistance develops in the context of AD. Studies show that circadian
      disruption impairs metabolic control and increases the risk for diabetes and obesity. Vice
      versa, disrupted sleep and depression are closely linked to impaired metabolic control and
      increased diabetes risk in the general population. Notably, AD is associated with circadian
      disruption, which may be amplified by exposure to irregular light-dark patterns or constant
      dim light. To what extent circadian disruption contributes to increased diabetes risk in AD
      remains unclear. Here, the investigator aims to test whether a novel tailored lighting
      intervention (TLI) designed to promote circadian entrainment in AD patients can improve
      metabolic control. Preliminary data from ongoing studies demonstrates a beneficial effect of
      light treatment on sleep and depression. Given the close association of sleep on metabolic
      control, these data support the hypothesis that light therapy that promotes entrainment can
      restore metabolic control in AD patients. Specifically, the investigator will test the
      efficacy of a practical, scientifically sophisticated 24-hour lighting system for increasing
      circadian entrainment in older adults with AD and related dementias (ADRD). The major goal is
      to demonstrate that a practical, effective, tailored, nonpharmacological intervention that
      promotes circadian entrainment can be used to improve sleep, reduce inflammation, and
      ameliorate glucose intolerance and insulin resistance in AD/ADRD patients.

      Aim 1: Test if a TLI that promotes entrainment can improve sleep, depression, inflammation,
      and glucose tolerance in patients with moderate to late stages ADRD. In a randomized,
      placebo-controlled, crossover study involving 60 ADRD patients who live in controlled
      environments, the investigators will investigate whether an 8-week exposure to a TLI designed
      to increase circadian entrainment (urinary melatonin and activity-rest patterns) will improve
      inflammation and glucose tolerance (oral glucose tolerance test), and reduce sleep
      disturbances (actigraphy, Pittsburgh Sleep Quality Index, PSQI) and depressive symptoms
      (Cornell Scale for Depression in Dementia, CSDD) compared to a control, circadian-inactive
      light.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Crossover placebo controlled design
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in Glucose tolerance
time frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
description: change in glucose tolerance from baseline will be assessed using an oral glucose tolerance test
measure: Change in sleep disturbance
time frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
description: Change in sleep disturbance will be assessed using the Pittsburgh Sleep Quality Index. The sum of the 7 component scores yields a single global score. A person with a global score above 5 is considered to have sleep disturbances. A higher score indicates worsening sleep disturbance.
measure: Change in depression
time frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
description: A change in depression will be assessed using the Cornell Scale for Depression in Dementia. A score of twelve or more points indicates depression. A higher score indicates worsening depression.
measure: Sleep Efficiency using actigraphy
time frame: 7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
description: Actigraphs will be worn for 7 days during assessment weeks. Actigraphy will be used to calculate changes in sleep efficiency. A higher sleep efficiency indicates better sleep.
measure: Light exposure using the Daysimeter
time frame: 7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
description: Daysimeters will be worn for 7 days during assessment periods to measure the amount of circadian effective light delivered by the lighting intervention.
arm group label: Aim 1: Active Intervention then Placebo
arm group type: Experimental
description: Tailored Lighting intervention (TLI). The active TLI will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. The active lighting intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the placebo control intervention for 8 weeks.
arm group label: Aim 1: Placebo Intervention then Active
arm group type: Experimental
description: The placebo lighting intervention is designed to have no effect on the circadian system. The control intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the active tailored lighting intervention for 8 weeks.
intervention type: Device
intervention name: Tailored Lighting Intervention
description: Lighting Intervention - active or placebo
arm group label: Aim 1: Active Intervention then Placebo
arm group label: Aim 1: Placebo Intervention then Active
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Mariana Figueiro, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Barbara Plitnick, BSN
phone: 518-242-4603
email: barbara.plitnick@mountsinai.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Mariana Figueiro
investigator title: Professor, Population Health Science and Policy
mesh term: Alzheimer Disease
mesh term: Metabolic Syndrome
mesh term: Diabetes Mellitus, Type 2