xml: <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/NCT05985486</url>
    </required_header>
    <id_info>
      <org_study_id>Study 150542</org_study_id>
      <nct_id>NCT05985486</nct_id>
    </id_info>
    <brief_title>Brain Outcomes With Lifestyle Change in Down Syndrome</brief_title>
    <acronym>BOLD</acronym>
    <official_title>The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Kansas Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Kansas Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this study is to determine if weight loss or changes can help prevent of delay&#xD;
        adults with Down syndrome from developing Alzheimer's Disease&#xD;
  &#xD;
        Adults with Down syndrome without dementia will be randomized to either a weight loss group&#xD;
        or a general health education control group. The weight loss group will be asked to follow a&#xD;
        reduced energy diet, attend monthly education sessions delivered remotely and self-monitor&#xD;
        diet and body weight using commercially available web-based applications. The control group&#xD;
        will be asked to attend remotely delivered monthly education sessions on general health&#xD;
        education topics.&#xD;
  &#xD;
        All participants will come to the University of Kansas Medical Center, 3 times across 12&#xD;
        months for a blood draw, cognitive testing, a MRI, assessment of height and weight, and&#xD;
        assessment of diet intake.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2024</start_date>
    <completion_date type="Anticipated">September 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2027</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 (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Plasma Amyloid beta 42:40 ratio</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines the amount of amyloid beta in a person's brain, measured by a blood draw.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Neurofilament light</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Weight</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines how much a person weights, measured by standing on a scale.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cognitive Function</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines cognitive function measured using the National Alzheimer's Coordinating Center's DS Module.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brian Volume</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines how much white and grey matter a person has in their brain, measured by MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brain antioxidants</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary Intake</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines what someone is eating, measured by writing down what a person eats over 3 days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin carotenoid content</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma Phosphorylated Tau</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines the amount of Tau in a person's brain, collected by a blood draw.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glial Fibrillary Acidic Protein</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Height</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines how tall a person is, measured on a stadiometer</description>
    </other_outcome>
    <other_outcome>
      <measure>Waist circumference</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines the distance around the smallest part of a person's torso, measured with a measuring tape</description>
    </other_outcome>
    <other_outcome>
      <measure>Attendance at education sessions</measure>
      <time_frame>Across 12 months</time_frame>
      <description>Examines how often individuals attendance the monthly education sessions. Obtained from interventionist records and expressed as the percentage of possible sessions attended.</description>
    </other_outcome>
    <other_outcome>
      <measure>Compliance with self-monitoring of diet</measure>
      <time_frame>Across 12 months</time_frame>
      <description>Assessed as the percentage of days a person tracked what they ate across the study.</description>
    </other_outcome>
    <other_outcome>
      <measure>Physical Activity</measure>
      <time_frame>Baseline, 6, 12 months</time_frame>
      <description>Examines Daily minutes of light, moderate, and vigorous physical activity as well as sedentary time using an ActiGraph tri-axial accelerometer worn on a wrist for 7 days.</description>
    </other_outcome>
    <other_outcome>
      <measure>Structured interviews</measure>
      <time_frame>12 months</time_frame>
      <description>A 20% random sample of participants and study partners from each intervention arm will complete a 30 minute interview to gather information that might be useful for improving the intervention.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">81</enrollment>
    <condition>Down Syndrome</condition>
    <condition>Alzheimer Disease</condition>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Weight Loss</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Follow a reduced calorie diet daily for 12 months.&#xD;
  Attend monthly behavioral counseling/education</description>
    </arm_group>
    <arm_group>
      <arm_group_label>General Health Education Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>- Attend monthly health education sessions about general health.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Diet</intervention_name>
      <description>A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.</description>
      <arm_group_label>Weight Loss</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health Education</intervention_name>
      <description>Monthly health education sessions delivered remotely.</description>
      <arm_group_label>General Health Education Control</arm_group_label>
      <arm_group_label>Weight Loss</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of Down syndrome&#xD;
  &#xD;
            -  BMI of 25 to 45 kg/m2&#xD;
  &#xD;
            -  Ability to communicate through spoken language.&#xD;
  &#xD;
            -  Ability to come to the University of Kansas Medical Center 3 times across 1 year for&#xD;
               outcomes testing&#xD;
  &#xD;
            -  Living at home with a parent/guardian, or in a supported living environment with a&#xD;
               caregiver who assists with food shopping, meal planning, and meal preparation and&#xD;
               agrees to serve as a study partner including providing transportation to our&#xD;
               facilities for study assessments.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of dementia&#xD;
  &#xD;
            -  Insulin dependent diabetes&#xD;
  &#xD;
            -  Participation in a weight management program involving diet or physical activity in&#xD;
               the past 6 mos.&#xD;
  &#xD;
            -  Dairy allergy&#xD;
  &#xD;
            -  Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy,&#xD;
               angioplasty)&#xD;
  &#xD;
            -  Unwilling to be randomized&#xD;
  &#xD;
            -  Contraindications for MRI, including metal implants or devices incompatible with MRI&#xD;
               such as pacemakers, claustrophobia, and inability to lay in a supine position&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lauren Ptomey, PhD</last_name>
      <phone>913-588-7982</phone>
      <email>lptomey@kumc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jessica Danon</last_name>
      <phone>785-764-3574</phone>
      <email>jdanon@kumc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Kansas Medical Center</name>
        <address>
          <city>Kansas City</city>
          <state>Kansas</state>
          <zip>66160</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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>Alzheimer Disease</mesh_term>
      <mesh_term>Down Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985486
  org study id: Study 150542
  nct id: NCT05985486
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to determine if weight loss or changes can help prevent of delay
        adults with Down syndrome from developing Alzheimer's Disease
  
        Adults with Down syndrome without dementia will be randomized to either a weight loss group
        or a general health education control group. The weight loss group will be asked to follow a
        reduced energy diet, attend monthly education sessions delivered remotely and self-monitor
        diet and body weight using commercially available web-based applications. The control group
        will be asked to attend remotely delivered monthly education sessions on general health
        education topics.
  
        All participants will come to the University of Kansas Medical Center, 3 times across 12
        months for a blood draw, cognitive testing, a MRI, assessment of height and weight, and
        assessment of diet intake.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Investigator, Outcomes Assessor)
  measure: Plasma Amyloid beta 42:40 ratio
  time frame: Baseline, 6, 12 months
  description: Examines the amount of amyloid beta in a person's brain, measured by a blood draw.
  measure: Neurofilament light
  time frame: Baseline, 6, 12 months
  description: Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.
  measure: Weight
  time frame: Baseline, 6, 12 months
  description: Examines how much a person weights, measured by standing on a scale.
  measure: Cognitive Function
  time frame: Baseline, 6, 12 months
  description: Examines cognitive function measured using the National Alzheimer's Coordinating Center's DS Module.
  measure: Brian Volume
  time frame: Baseline, 6, 12 months
  description: Examines how much white and grey matter a person has in their brain, measured by MRI
  measure: Brain antioxidants
  time frame: Baseline, 6, 12 months
  description: Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI
  measure: Dietary Intake
  time frame: Baseline, 6, 12 months
  description: Examines what someone is eating, measured by writing down what a person eats over 3 days.
  measure: Skin carotenoid content
  time frame: Baseline, 6, 12 months
  description: Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter.
  measure: Plasma Phosphorylated Tau
  time frame: Baseline, 6, 12 months
  description: Examines the amount of Tau in a person's brain, collected by a blood draw.
  measure: Glial Fibrillary Acidic Protein
  time frame: Baseline, 6, 12 months
  description: Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw.
  measure: Height
  time frame: Baseline, 6, 12 months
  description: Examines how tall a person is, measured on a stadiometer
  measure: Waist circumference
  time frame: Baseline, 6, 12 months
  description: Examines the distance around the smallest part of a person's torso, measured with a measuring tape
  measure: Attendance at education sessions
  time frame: Across 12 months
  description: Examines how often individuals attendance the monthly education sessions. Obtained from interventionist records and expressed as the percentage of possible sessions attended.
  measure: Compliance with self-monitoring of diet
  time frame: Across 12 months
  description: Assessed as the percentage of days a person tracked what they ate across the study.
  measure: Physical Activity
  time frame: Baseline, 6, 12 months
  description: Examines Daily minutes of light, moderate, and vigorous physical activity as well as sedentary time using an ActiGraph tri-axial accelerometer worn on a wrist for 7 days.
  measure: Structured interviews
  time frame: 12 months
  description: A 20% random sample of participants and study partners from each intervention arm will complete a 30 minute interview to gather information that might be useful for improving the intervention.
  arm group label: Weight Loss
  arm group type: Experimental
  description: Follow a reduced calorie diet daily for 12 months.
  Attend monthly behavioral counseling/education
  arm group label: General Health Education Control
  arm group type: Active Comparator
  description: - Attend monthly health education sessions about general health.
  intervention type: Behavioral
  intervention name: Diet
  description: A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
  arm group label: Weight Loss
  intervention type: Behavioral
  intervention name: Health Education
  description: Monthly health education sessions delivered remotely.
  arm group label: General Health Education Control
  arm group label: Weight Loss
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Lauren Ptomey, PhD
  phone: 913-588-7982
  email: lptomey@kumc.edu
  last name: Jessica Danon
  phone: 785-764-3574
  email: jdanon@kumc.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  mesh term: Down Syndrome
  mesh term: Syndrome
  sharing ipd: Undecided