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/NCT06027320</url>
    </required_header>
    <id_info>
      <org_study_id>20216157</org_study_id>
      <secondary_id>4R44AG071416</secondary_id>
      <nct_id>NCT06027320</nct_id>
    </id_info>
    <brief_title>The Retain Your Brain Health Study (RetainYourBrain.Com)</brief_title>
    <official_title>Risk Education Technology As Individualized Neuroprotection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Retain Health, Inc</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Cincinnati</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Retain Health, Inc</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 clinical trial is to test a cell phone based online program that provides&#xD;
        Alzheimer's risk assessments and memory tests over a 6-month period. The main question it&#xD;
        aims to answer is whether online software can help reduce the risk of Alzheimer's disease&#xD;
        (AD) through digital education and tracking.&#xD;
  &#xD;
        Participants will visit RetainYourBrain.com to answer questions about their risk factors for&#xD;
        AD and take online &quot;card game&quot; type cognitive tests. Researchers will track progress over&#xD;
        time and compare different strategies of Alzheimer's education to see if it is possible to&#xD;
        protect brain health, reduce Alzheimer's risk and optimize memory function.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Alzheimer's disease (AD) is a public health crisis with few effective treatments. However,&#xD;
        most people are unaware that AD begins in the brain decades before the first symptom of&#xD;
        memory loss begins. That leaves a lot of time for people to learn their individual risk&#xD;
        factors for AD and cognitive decline, and take memory assessment screening tests, in effort&#xD;
        toward prevention or delay of dementia. To reach a growing at-risk population, mobile health&#xD;
        technologies accessible via cell phone can fill an unmet need due to accessibility and&#xD;
        cost-effective delivery of care. Online education and text messaging has proven to be an&#xD;
        effective method of reducing risk a variety of chronic conditions, such as cardiovascular&#xD;
        disease and diabetes, which are both key drivers of AD risk.&#xD;
  &#xD;
        We created a cell phone based online software application to provide automated,&#xD;
        individualized monitoring and education, at broad scale. The goal of the software is to&#xD;
        functions as a digital therapeutic to identify individual risk factors, assess memory and&#xD;
        cognitive function over time, and educate people with a family history of AD. The system&#xD;
        maintains bi-directional communication via text message to verify user engagement.&#xD;
  &#xD;
        Participants who visit our study website (www.RetainYourBrain.com) will be directed to answer&#xD;
        questions assessing eligibility criteria. Participants who are eligible to participate are&#xD;
        asked to electronically sign an informed consent, complete baseline assessments, and take a&#xD;
        &quot;card game&quot; like memory test. Participants will then be randomized to one of two groups using&#xD;
        different strategies for AD risk assessment education. Researchers will track progress over&#xD;
        six months and compare different strategies of education to determine if it is possible to&#xD;
        protect brain health, reduce Alzheimer's risk and optimize memory function.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">January 2, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Australian National University-AD Risk Index (ANU-ADRI)</measure>
      <time_frame>Baseline, 3 and 6 month.</time_frame>
      <description>The ANU-ADRI is an evidence-based, validated, tool aimed at assessing individual exposure to risk factors known to be associated with an increased risk of developing late-life Alzheimer's Disease (AD). The ANU-ADRI provides an individualized assessment and has been used in studies aiming to evaluate methods of reducing AD risk.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cogstate Brief Battery (CBB)</measure>
      <time_frame>Baseline, 3 and 6 month.</time_frame>
      <description>Cognition will be measured by the Attention/Psychomotor composite score and the Learning/Working Memory composite from the CBB.&#xD;
  The CBB is a brief, internet-based administered cognitive test consisting of four tasks that measure the following: attention, processing speed, learning and working memory. The CBB was developed to detect cognitive changes in the preclinical stages of AD.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fear of Alzheimer's Disease Scale (FADS)</measure>
      <time_frame>Baseline, 3 and 6 month.</time_frame>
      <description>The FADS is a self-reported valid instrument to directly address anticipatory dementia among a general population of older adults. It assesses 3 main topics: general fear of AD, physiological symptoms accompanying FAD, and catastrophic attitudes associated with FAD.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>User Satisfaction</measure>
      <time_frame>3 and 6 month.</time_frame>
      <description>A brief questionnaire will be given to understand how satisfied an individual is with the online software application.</description>
    </other_outcome>
    <other_outcome>
      <measure>Cost Effectiveness</measure>
      <time_frame>3 and 6 month.</time_frame>
      <description>A brief questionnaire will be given to analyze if there are any costs associated with using the online software application.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">736</enrollment>
    <condition>Alzheimer Disease</condition>
    <condition>Dementia</condition>
    <condition>Healthy Participants</condition>
    <condition>Brain Health</condition>
    <arm_group>
      <arm_group_label>Brain Health Education Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive an Alzheimer's risk assessment, memory testing and brain health education, in addition to text message communication.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Alzheimer Disease Education Arm</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Subjects will receive an Alzheimer's risk assessment, memory testing and general education about Alzheimer's disease, in addition to text message communication.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Brain Health Education</intervention_name>
      <description>Subjects will receive an Alzheimer's risk assessment, memory testing and brain health education, in addition to text message communication.</description>
      <arm_group_label>Brain Health Education Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Alzheimer Disease Education</intervention_name>
      <description>Subjects will receive an Alzheimer's risk assessment, memory testing and general education about Alzheimer's disease, in addition to text message communication.</description>
      <arm_group_label>Alzheimer Disease Education Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  be at least 53 years of age&#xD;
  &#xD;
            -  have a family history of Alzheimer's Disease (AD)&#xD;
  &#xD;
            -  have a compatible phone/device (phone allowing text messages and with internet access,&#xD;
               and/or tablet device with the same capabilities)&#xD;
  &#xD;
            -  a minimum of one of the following risk factors: body mass index (BMI) of more than 25&#xD;
               history of pre-diabetes/diabetes high blood pressure high cholesterol smoking low&#xD;
               physical activity, less than 2 times per week low fish intake, less than 3 times per&#xD;
               month high alcohol intake, more than 7 servings per week for a women and more than 14&#xD;
               servings a week for men diagnosed with mild or moderate depression&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having a diagnosis of dementia due to AD&#xD;
  &#xD;
            -  other dementia&#xD;
  &#xD;
            -  women who are currently pregnant or who plan on becoming pregnant in the next 6 months&#xD;
  &#xD;
            -  BMI &lt;18.5kg/m2&#xD;
  &#xD;
            -  consuming &gt;35 alcoholic drinks/week for men or &gt;28 alcoholic drinks/week for women&#xD;
  &#xD;
            -  severe depression (PHQ-9 score of more than 15)&#xD;
  &#xD;
            -  current treatment for cancer&#xD;
  &#xD;
            -  diagnosis of Parkinson's disease, amyotrophic lateral sclerosis, Lewy body dementia,&#xD;
               frontotemporal disorders, multiple sclerosis, or other neurodegenerative disease&#xD;
  &#xD;
            -  current treatment for an eating disorder&#xD;
  &#xD;
            -  currently prescribed insulin for type I or II diabetes&#xD;
  &#xD;
            -  inability to give informed consent or complete identity verification&#xD;
  &#xD;
            -  participating in another AD trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>53 Years</minimum_age>
      <maximum_age>105 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tammie Elgammal, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Retain Health, Inc</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Robert Krikorian, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Cincinnati School of Medicine</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mark McInnis, BA</last_name>
      <role>Principal Investigator</role>
      <affiliation>Retain Health, Inc</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tammie Elgammal, MD</last_name>
      <phone>561-320-3507</phone>
      <email>tammie@retainhealth.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mark McInnis, BA</last_name>
      <phone>781-222-8053</phone>
      <email>mmcinnis@retainhealth.com</email>
    </overall_contact_backup>
    <link>
      <url>http://www.RetainYourBrain.com</url>
      <description>RetainYourBrain Page</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Alzheimer's</keyword>
    <keyword>prevention</keyword>
    <keyword>Clinical Trial</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data sharing is an essential part of our proposed activities. We intend to make our results available to the scientific community to contribute to knowledge of the field and avoid unintentional duplication of research. Data from this study will be placed in a research database. Proposals for research will be reviewed by the Principal Investigator and the data will be made available to qualified researchers via a secure portal.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Six-months after publication of full study results.</ipd_time_frame>
      <ipd_access_criteria>Data will be made available to qualified researchers via a secure portal.</ipd_access_criteria>
      <ipd_url>http://www.RetainYourBrain.com</ipd_url>
    </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/NCT06027320
  org study id: 20216157
  secondary id: 4R44AG071416
  nct id: NCT06027320
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test a cell phone based online program that provides
        Alzheimer's risk assessments and memory tests over a 6-month period. The main question it
        aims to answer is whether online software can help reduce the risk of Alzheimer's disease
        (AD) through digital education and tracking.
  
        Participants will visit RetainYourBrain.com to answer questions about their risk factors for
        AD and take online "card game" type cognitive tests. Researchers will track progress over
        time and compare different strategies of Alzheimer's education to see if it is possible to
        protect brain health, reduce Alzheimer's risk and optimize memory function.
  Alzheimer's disease (AD) is a public health crisis with few effective treatments. However,
        most people are unaware that AD begins in the brain decades before the first symptom of
        memory loss begins. That leaves a lot of time for people to learn their individual risk
        factors for AD and cognitive decline, and take memory assessment screening tests, in effort
        toward prevention or delay of dementia. To reach a growing at-risk population, mobile health
        technologies accessible via cell phone can fill an unmet need due to accessibility and
        cost-effective delivery of care. Online education and text messaging has proven to be an
        effective method of reducing risk a variety of chronic conditions, such as cardiovascular
        disease and diabetes, which are both key drivers of AD risk.
  
        We created a cell phone based online software application to provide automated,
        individualized monitoring and education, at broad scale. The goal of the software is to
        functions as a digital therapeutic to identify individual risk factors, assess memory and
        cognitive function over time, and educate people with a family history of AD. The system
        maintains bi-directional communication via text message to verify user engagement.
  
        Participants who visit our study website (www.RetainYourBrain.com) will be directed to answer
        questions assessing eligibility criteria. Participants who are eligible to participate are
        asked to electronically sign an informed consent, complete baseline assessments, and take a
        "card game" like memory test. Participants will then be randomized to one of two groups using
        different strategies for AD risk assessment education. Researchers will track progress over
        six months and compare different strategies of education to determine if it is possible to
        protect brain health, reduce Alzheimer's risk and optimize memory function.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Australian National University-AD Risk Index (ANU-ADRI)
  time frame: Baseline, 3 and 6 month.
  description: The ANU-ADRI is an evidence-based, validated, tool aimed at assessing individual exposure to risk factors known to be associated with an increased risk of developing late-life Alzheimer's Disease (AD). The ANU-ADRI provides an individualized assessment and has been used in studies aiming to evaluate methods of reducing AD risk.
  measure: Cogstate Brief Battery (CBB)
  time frame: Baseline, 3 and 6 month.
  description: Cognition will be measured by the Attention/Psychomotor composite score and the Learning/Working Memory composite from the CBB.
  The CBB is a brief, internet-based administered cognitive test consisting of four tasks that measure the following: attention, processing speed, learning and working memory. The CBB was developed to detect cognitive changes in the preclinical stages of AD.
  measure: Fear of Alzheimer's Disease Scale (FADS)
  time frame: Baseline, 3 and 6 month.
  description: The FADS is a self-reported valid instrument to directly address anticipatory dementia among a general population of older adults. It assesses 3 main topics: general fear of AD, physiological symptoms accompanying FAD, and catastrophic attitudes associated with FAD.
  measure: User Satisfaction
  time frame: 3 and 6 month.
  description: A brief questionnaire will be given to understand how satisfied an individual is with the online software application.
  measure: Cost Effectiveness
  time frame: 3 and 6 month.
  description: A brief questionnaire will be given to analyze if there are any costs associated with using the online software application.
  arm group label: Brain Health Education Arm
  arm group type: Experimental
  description: Subjects will receive an Alzheimer's risk assessment, memory testing and brain health education, in addition to text message communication.
  arm group label: Alzheimer Disease Education Arm
  arm group type: Other
  description: Subjects will receive an Alzheimer's risk assessment, memory testing and general education about Alzheimer's disease, in addition to text message communication.
  intervention type: Behavioral
  intervention name: Brain Health Education
  description: Subjects will receive an Alzheimer's risk assessment, memory testing and brain health education, in addition to text message communication.
  arm group label: Brain Health Education Arm
  intervention type: Behavioral
  intervention name: Alzheimer Disease Education
  description: Subjects will receive an Alzheimer's risk assessment, memory testing and general education about Alzheimer's disease, in addition to text message communication.
  arm group label: Alzheimer Disease Education Arm
  criteria: 
  gender: All
  minimum age: 53 Years
  maximum age: 105 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tammie Elgammal, MD
  role: Principal Investigator
  affiliation: Retain Health, Inc
  last name: Robert Krikorian, PhD
  role: Principal Investigator
  affiliation: University of Cincinnati School of Medicine
  last name: Mark McInnis, BA
  role: Principal Investigator
  affiliation: Retain Health, Inc
  last name: Tammie Elgammal, MD
  phone: 561-320-3507
  email: tammie@retainhealth.com
  last name: Mark McInnis, BA
  phone: 781-222-8053
  email: mmcinnis@retainhealth.com
  url: http://www.RetainYourBrain.com
  description: RetainYourBrain Page
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  sharing ipd: Yes
  ipd description: Data sharing is an essential part of our proposed activities. We intend to make our results available to the scientific community to contribute to knowledge of the field and avoid unintentional duplication of research. Data from this study will be placed in a research database. Proposals for research will be reviewed by the Principal Investigator and the data will be made available to qualified researchers via a secure portal.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Six-months after publication of full study results.
  ipd access criteria: Data will be made available to qualified researchers via a secure portal.
  ipd url: http://www.RetainYourBrain.com