<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/NCT04466722</url>
  </required_header>
  <id_info>
    <org_study_id>A-LIST Protocol 1</org_study_id>
    <nct_id>NCT04466722</nct_id>
  </id_info>
  <brief_title>The A-LIST WMM Insights Series</brief_title>
  <official_title>A-LIST What Matters Most Insights Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UsAgainstAlzheimer's</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UsAgainstAlzheimer's</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>
      The main purpose of the Study is to develop an understanding over time and through multiple&#xD;
      research projects, including surveys, interviews, online focus groups, and other primary&#xD;
      research methodologies (A-LIST Research Projects) on what matters most to individuals&#xD;
      concerned about brain health and those with and/or affected by Alzheimer's disease and other&#xD;
      dementias, including caregivers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To do this, UsAgainstAlzheimer's will identify and engage individuals who want to focus on&#xD;
      brain health; individuals who are worried about their cognition; individuals who perceive&#xD;
      themselves to be at risk for Alzheimer's disease (AD); individuals who may be at risk for AD&#xD;
      due to self-identified confirmation of underlying disease pathology; individuals who&#xD;
      self-identify as having a diagnosis of mild cognitive impairment (MCI) or of AD or another&#xD;
      dementia; and those who self-identify as current or former caregivers of patients with&#xD;
      Alzheimer's disease or another dementia to participate in the A-LIST Research Projects. Such&#xD;
      participants will either already be - or will be invited to become - members of the A-LIST&#xD;
      cohort, an online cohort of individuals ready and willing to engage in A-LIST WMM Insights&#xD;
      Series (A-LIST members).&#xD;
&#xD;
      The A-LIST WMM Insights Series will enlist participants to offer insights into a range of&#xD;
      issues relevant to Alzheimer's, including as examples issues pertinent to clinical trial&#xD;
      design, regulatory submissions, other research strategies, payer value determinations, and&#xD;
      care and services research. The A-LIST WMM Insights Series may seek information that in some&#xD;
      instances will be marketing research or other research exempt from IRB oversight. However,&#xD;
      when an individual A-LIST Research Project constitutes human subjects research consistent&#xD;
      with governing law, IRB approval will be sought and obtained. Where questions exist whether&#xD;
      an individual A-LIST Research Project constitutes human subject research, IRB determination&#xD;
      will be solicited.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 15, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Phenotypical Characteristics of Patients and Caregivers</measure>
    <time_frame>3 years</time_frame>
    <description>Online monthly surveys capture the burden and unmet needs for patients and caregivers of individuals with or at risk for Alzheimer's disease, other dementias, and mild cognitive impairment; also recruiting individuals interested in brain health.</description>
  </primary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Dementia</condition>
  <condition>Mild Cognitive Impairment</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who want to focus on brain health; individuals who are worried about their&#xD;
        cognition; individuals who perceive themselves to be at risk for Alzheimer's disease (AD);&#xD;
        individuals who may be at risk for due to self-identified confirmation of underlying&#xD;
        disease pathology; individuals who self-identify as having a diagnosis of mild cognitive&#xD;
        impairment (MCI) or of AD or another dementia; and those who self-identify as current or&#xD;
        former caregivers of patients with Alzheimer's disease or another dementia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be eligible to participate in the Study, an individual must meet all of the following&#xD;
        criteria:&#xD;
&#xD;
          1. Age 18 years or older.&#xD;
&#xD;
          2. United States, Canada resident.&#xD;
&#xD;
          3. Self-report of cognitive difficulties, caregiver status or interest in brain health.&#xD;
&#xD;
          4. Have indicated willingness to participate by selecting &quot;I Agree&quot; option when joining&#xD;
             the A-LIST. Additionally, will have clicked on link - invitation to take a specific&#xD;
             survey&#xD;
&#xD;
          5. Able to speak, read, and understand English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        An individual who meets any of the following criteria will be excluded from participation&#xD;
        in this Study:&#xD;
&#xD;
        1. Unable to comply with the Study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theresa Frangiosa, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>UsAgainstAlzheimer's</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Virginia Biggar, BA</last_name>
    <phone>3014521123</phone>
    <email>vbiggar@usagainstalzheimers.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Theresa Frangiosa, MBA</last_name>
    <phone>908-872-5815</phone>
    <email>tfrangiosa@usagainstalzheimers.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UsAgainstAlzheimer's</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20043</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Virginia Biggar, BA</last_name>
      <phone>301-452-1123</phone>
      <email>vbiggar@usagainstalzheimers.org</email>
    </contact>
    <investigator>
      <last_name>Theresa Frangiosa, MBA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.usagainstalzheimers.org/networks/A-LIST</url>
    <description>Join UsAgainstAlzheimer's A-LIST</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer</keyword>
  <keyword>Dementia</keyword>
  <keyword>Cognitive</keyword>
  <keyword>Cognition</keyword>
  <keyword>Brain health</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04466722
org study id: A-LIST Protocol 1
nct id: NCT04466722
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of the Study is to develop an understanding over time and through multiple
      research projects, including surveys, interviews, online focus groups, and other primary
      research methodologies (A-LIST Research Projects) on what matters most to individuals
      concerned about brain health and those with and/or affected by Alzheimer's disease and other
      dementias, including caregivers.
To do this, UsAgainstAlzheimer's will identify and engage individuals who want to focus on
      brain health; individuals who are worried about their cognition; individuals who perceive
      themselves to be at risk for Alzheimer's disease (AD); individuals who may be at risk for AD
      due to self-identified confirmation of underlying disease pathology; individuals who
      self-identify as having a diagnosis of mild cognitive impairment (MCI) or of AD or another
      dementia; and those who self-identify as current or former caregivers of patients with
      Alzheimer's disease or another dementia to participate in the A-LIST Research Projects. Such
      participants will either already be - or will be invited to become - members of the A-LIST
      cohort, an online cohort of individuals ready and willing to engage in A-LIST WMM Insights
      Series (A-LIST members).

      The A-LIST WMM Insights Series will enlist participants to offer insights into a range of
      issues relevant to Alzheimer's, including as examples issues pertinent to clinical trial
      design, regulatory submissions, other research strategies, payer value determinations, and
      care and services research. The A-LIST WMM Insights Series may seek information that in some
      instances will be marketing research or other research exempt from IRB oversight. However,
      when an individual A-LIST Research Project constitutes human subjects research consistent
      with governing law, IRB approval will be sought and obtained. Where questions exist whether
      an individual A-LIST Research Project constitutes human subject research, IRB determination
      will be solicited.
observational model: Cohort
time perspective: Prospective
measure: Phenotypical Characteristics of Patients and Caregivers
time frame: 3 years
description: Online monthly surveys capture the burden and unmet needs for patients and caregivers of individuals with or at risk for Alzheimer's disease, other dementias, and mild cognitive impairment; also recruiting individuals interested in brain health.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Theresa Frangiosa, MBA
role: Principal Investigator
affiliation: UsAgainstAlzheimer's
last name: Virginia Biggar, BA
phone: 3014521123
email: vbiggar@usagainstalzheimers.org
last name: Theresa Frangiosa, MBA
phone: 908-872-5815
email: tfrangiosa@usagainstalzheimers.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://www.usagainstalzheimers.org/networks/A-LIST
description: Join UsAgainstAlzheimer's A-LIST
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Cognitive Dysfunction
sharing ipd: No