<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/NCT04471779</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR8269</org_study_id>
    <secondary_id>R01AG062528</secondary_id>
    <nct_id>NCT04471779</nct_id>
  </id_info>
  <brief_title>Information About Alzheimer's Disease for Latinos in New York City</brief_title>
  <acronym>IDEAL</acronym>
  <official_title>The IDEAL Study: Information About Alzheimer's Disease for Latinos in New York City</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</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>
      This study will assess the psychosocial and behavioral impacts of receiving Alzheimer's&#xD;
      disease genetic risk assessment incorporating APOE genotypes among Latinos in northern&#xD;
      Manhattan. The investigators will conduct a longitudinal, community-based study with a mixed&#xD;
      methods design. Participants will be randomized to learn about their lifetime risk of&#xD;
      late-onset Alzheimer's disease (AD) based either on (a) Latino ethnicity and family history&#xD;
      alone (genotype nondisclosure group), or (b) the same factors plus APOE genotype (genotype&#xD;
      disclosure group). Responses will be evaluated at 6 weeks, 9 months, and 15 months after risk&#xD;
      assessment. In the quantitative component of the study, the investigators will assess&#xD;
      psychosocial outcomes, memory test performance, and health-related behaviors. In the&#xD;
      qualitative component of the study, the investigators will investigate the lived experience&#xD;
      of receiving personal AD risk information, using a stress and coping theoretical framework.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Apolipoprotein E (APOE) is the strongest genetic predictor of risk for late-onset Alzheimer's&#xD;
      disease (AD). Given the high level of interest in genetic testing, the demand for predictive&#xD;
      testing for APOE will surely increase. Improved understanding of the impacts of testing,&#xD;
      sources of variability in response, and inclusion of diverse samples are critical for&#xD;
      informing methods to promote safe and effective disclosure of AD genetic risk information.&#xD;
&#xD;
      As with other diseases, previous research on AD, a devastating and incurable illness, has&#xD;
      found little significant or sustained distress in response to genetic susceptibility testing&#xD;
      for APOE, even among persons who learn they are at elevated risk. These surprising findings,&#xD;
      which run counter to the experience of many clinicians, may be related to limitations in the&#xD;
      methods of previous studies. Most previous studies primarily enrolled well-educated&#xD;
      Caucasians with a family history, who were strongly motivated to pursue genetic risk&#xD;
      information. Further, most studies assessed impacts primarily through standardized measures&#xD;
      of depression and anxiety, which may not capture the kinds of distress experienced or coping&#xD;
      strategies that might blunt or mask distress. Qualitative research shows that receipt of&#xD;
      genetic information can have important psychosocial effects not well captured through&#xD;
      standardized measures. Also, in one study, people with a high-risk gene test for APOE&#xD;
      performed worse on memory tests if they were informed about the results than if they were not&#xD;
      informed, suggesting that other impact measures are needed.&#xD;
&#xD;
      Another important limitation of prior work is that it has lacked representation of ethnic&#xD;
      minority groups. Latinos are the second largest U.S. ethnic group, comprising about 18% of&#xD;
      the population, yet no previous study has investigated the impacts of receiving AD genetic&#xD;
      risk information among Latinos. While AD incidence rates may vary among Latino subgroups,&#xD;
      data from the Washington Heights-Inwood Columbia Aging Project (WHICAP), a study in northern&#xD;
      Manhattan, indicate that they are about twice as high among Caribbean Hispanics (primarily&#xD;
      Dominicans) as among persons of European ancestry.&#xD;
&#xD;
      In this study, the investigators will improve understanding of the impacts of receiving&#xD;
      personal AD genetic risk information and the factors that influence adjustment to such&#xD;
      information among Latinos who live in the same communities studied in WHICAP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 29, 2021</start_date>
  <completion_date type="Anticipated">November 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2025</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>
    <intervention_model_description>The investigators estimate that 2171 people will participate in the Baseline Survey, of whom 400 will be included in the follow-up study. Half of those in the follow-up study will be randomized to receive information about their risk of Alzheimer's disease based on Latino ethnicity, family history, and APOE genotype, and half will be randomized to receive information about their risk based on ethnicity and family history alone.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Persons conducting follow-up surveys via computer-assisted telephone interviews will be masked with respect to participant randomization group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of Genetic Testing in AD (IGT-AD)</measure>
    <time_frame>6 weeks after risk evaluation</time_frame>
    <description>16-item scale that assesses the impact of test result disclosure across both distress and positive domains. The scale will be modified to anchor it to &quot;risk assessment&quot; rather than genetic test results to enable it to be used in both disclosure groups. Each item scored 0 (never), 1 (rarely) 3 (sometimes) 5 (often). Values are summed; higher total indicates worse outcome (greater adverse impact). Scale range: 0-80.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Genetic Testing in AD (IGT-AD)</measure>
    <time_frame>9 months after risk evaluation</time_frame>
    <description>16-item scale that assesses the impact of test result disclosure across both distress and positive domains. The scale will be modified to anchor it to &quot;risk assessment&quot; rather than genetic test results to enable it to be used in both disclosure groups. Each item scored 0 (never), 1 (rarely) 3 (sometimes) 5 (often). Values are summed; higher total indicates worse outcome (greater adverse impact). Scale range: 0-80.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Genetic Testing in AD (IGT-AD)</measure>
    <time_frame>15 months after risk evaluation</time_frame>
    <description>16-item scale that assesses the impact of test result disclosure across both distress and positive domains. The scale will be modified to anchor it to &quot;risk assessment&quot; rather than genetic test results to enable it to be used in both disclosure groups. Each item scored 0 (never), 1 (rarely) 3 (sometimes) 5 (often). Values are summed; higher total indicates worse outcome (greater adverse impact). Scale range: 0-80.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Event Scale-Revised</measure>
    <time_frame>6 weeks after risk evaluation</time_frame>
    <description>22-item scale to assess subjective distress caused by traumatic events. Each item scored on a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Subscales can be calculated for Intrusion, Avoidance, and Hyperarousal. The authors recommend using means instead of summed scores; higher mean score indicates worse outcome (greater impact). Scale range: 0-4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Event Scale-Revised</measure>
    <time_frame>9 months after risk evaluation</time_frame>
    <description>22-item scale to assess subjective distress caused by traumatic events. Each item scored on a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Subscales can be calculated for Intrusion, Avoidance, and Hyperarousal. The authors recommend using means instead of summed scores; higher mean score indicates worse outcome (greater impact). Scale range: 0-4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Event Scale-Revised</measure>
    <time_frame>15 months after risk evaluation</time_frame>
    <description>22-item scale to assess subjective distress caused by traumatic events. Each item scored on a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Subscales can be calculated for Intrusion, Avoidance, and Hyperarousal. The authors recommend using means instead of summed scores; higher mean score indicates worse outcome (greater impact). Scale range: 0-4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)</measure>
    <time_frame>Baseline and 6 weeks after risk evaluation</time_frame>
    <description>15-20 minute test of cognitive differences in normal aging. Composite score (the average of standardized z-scores for six measures: immediate memory, delayed memory, working memory, verbal fluency, speed, and reasoning. Lower scores indicate worse outcome (worse memory performance). Range of scale values: -1 to +1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)</measure>
    <time_frame>Baseline and 9 months after risk evaluation</time_frame>
    <description>15-20 minute test of cognitive differences in normal aging. Composite score (the average of standardized z-scores for six measures: immediate memory, delayed memory, working memory, verbal fluency, speed, and reasoning. Lower scores indicate worse outcome (worse memory performance). Range of scale values: -1 to +1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)</measure>
    <time_frame>Baseline and 15 months after risk evaluation</time_frame>
    <description>15-20 minute test of cognitive differences in normal aging. Composite score (the average of standardized z-scores for six measures: immediate memory, delayed memory, working memory, verbal fluency, speed, and reasoning. Lower scores indicate worse outcome (worse memory performance). Range of scale values: -1 to +1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Score on the Metamemory in Adulthood Questionnaire-Revised</measure>
    <time_frame>Baseline and 6 weeks after risk evaluation</time_frame>
    <description>20-item test of subjective memory. Each item measured on a 5-point Likert scale from 1 (agree strongly) to 5 (disagree strongly). Lower scores indicate worse outcome (worse subjective memory functioning and more decline in memory across time). Scale range: 20-100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Score on the Metamemory in Adulthood Questionnaire-Revised</measure>
    <time_frame>Baseline and 9 months after risk evaluation</time_frame>
    <description>20-item test of subjective memory. Each item measured on a 5-point Likert scale from 1 (agree strongly) to 5 (disagree strongly). Lower scores indicate worse outcome (worse subjective memory functioning and more decline in memory across time). Scale range: 20-100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Score on the Metamemory in Adulthood Questionnaire-Revised</measure>
    <time_frame>Baseline and 15 months after risk evaluation</time_frame>
    <description>20-item test of subjective memory. Each item measured on a 5-point Likert scale from 1 (agree strongly) to 5 (disagree strongly). Lower scores indicate worse outcome (worse subjective memory functioning and more decline in memory across time). Scale range: 20-100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Score on Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Baseline and 6 weeks after risk evaluation</time_frame>
    <description>9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Score on Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Baseline and 9 months after risk evaluation</time_frame>
    <description>9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Score on Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Baseline and 15 months after risk evaluation</time_frame>
    <description>9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Score on the General Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>Baseline and 6 weeks after risk evaluation</time_frame>
    <description>7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Score on the General Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>Baseline and 9 months after risk evaluation</time_frame>
    <description>7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Score on the General Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>Baseline and 15 months after risk evaluation</time_frame>
    <description>7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Threat of AD</measure>
    <time_frame>Baseline and 6 weeks after risk evaluation</time_frame>
    <description>7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Threat of AD</measure>
    <time_frame>Baseline and 9 months after risk evaluation</time_frame>
    <description>7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Threat of AD</measure>
    <time_frame>Baseline and 15 months after risk evaluation</time_frame>
    <description>7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related behavior changes</measure>
    <time_frame>6 weeks after risk evaluation</time_frame>
    <description>22 items, with each item answered yes (1) or no (0). Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related behavior changes</measure>
    <time_frame>9 months after risk evaluation</time_frame>
    <description>22 items, with each item answered yes (1) or no (0). Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related behavior changes</measure>
    <time_frame>15 months after risk evaluation</time_frame>
    <description>22 items, with each item answered yes (1) or no (0). Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recall/understanding of results</measure>
    <time_frame>6 weeks after risk evaluation</time_frame>
    <description>5 questions will be asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recall/understanding of results</measure>
    <time_frame>9 months after risk evaluation</time_frame>
    <description>5 questions will be asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recall/understanding of results</measure>
    <time_frame>15 months after risk evaluation</time_frame>
    <description>5 questions will be asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Disclosure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be given information about their risk of Alzheimer's disease based on Latino ethnicity, family history of Alzheimer's disease, and their APOE genotype.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-disclosure</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be given information about their risk of Alzheimer's disease based on Latino ethnicity and family history of Alzheimer's disease alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Disclosure of APOE genotype</intervention_name>
    <description>Information about risk of Alzheimer's disease will be given to participants based on their APOE genotypes, in addition to Latino ethnicity and family history.</description>
    <arm_group_label>Disclosure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  self-identified as Latino or Hispanic&#xD;
&#xD;
          -  age 40-64 years&#xD;
&#xD;
          -  current residence in target neighborhoods: Washington Heights, Inwood, Hamilton&#xD;
             Heights, Central Harlem, East Harlem, Morningside Heights, Manhattanville, or&#xD;
             Striver's Row, New York&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  does not self-identify as Latino&#xD;
&#xD;
          -  does not reside in target neighborhoods&#xD;
&#xD;
          -  not in applicable age range&#xD;
&#xD;
          -  has Alzheimer's disease&#xD;
&#xD;
          -  previously tested for APOE&#xD;
&#xD;
          -  has a family history consistent with autosomal dominant, early onset Alzheimer's&#xD;
             disease&#xD;
&#xD;
          -  has a positive screen for suicidality in Baseline Survey (any response other than &quot;not&#xD;
             at all&quot; to PHQ-9 item, &quot;thoughts that you would be better off dead or of hurting&#xD;
             yourself in some way&quot;)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruth Ottman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ruth Ottman, PhD</last_name>
    <phone>212-305-7892</phone>
    <email>ro6@cumc.columbia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karolynn Siegel, PhD</last_name>
    <phone>212-304-5578</phone>
    <email>ks420@cumc.columbia.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Ruth Ottman</investigator_full_name>
    <investigator_title>Professor of Epidemiology</investigator_title>
  </responsible_party>
  <keyword>Latinos</keyword>
  <keyword>New York (NY)</keyword>
  <keyword>Genetics</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>De-identified data from surveys collected in the study will be made available from the PIs, after acceptance for publication of the primary analyses of the survey data, to qualified researchers who sign a data user agreement as described below. The investigators will provide documentation of all survey data (variable names, variable formats, variable and value labels) to accompany the data, and will share the actual survey instruments upon request. Because interview transcripts can be highly identifying, they will not be shared. However, the codebooks and interview guides will be available from the PIs, after acceptance for publication of the primary analyses of the interviews, to qualified users as described below.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After acceptance for publication of the primary analyses of the study.</ipd_time_frame>
    <ipd_access_criteria>Data will be available to users only under a data user agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.&#xD;
Requests for data must be in writing and addressed to the co-PIs. We will create a data request form that will include investigator affiliation, contact information and a brief description of the project, including specific aims, study design, characteristics of the data requested, and analysis plans. Applications for data use will be reviewed by the co-PIs and a data use committee composed of the other co-investigators. Approval will be contingent upon institutional review board (IRB) approval for the proposed data analysis from the institution of the investigator requesting the data.</ipd_access_criteria>
  </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/NCT04471779
org study id: AAAR8269
secondary id: R01AG062528
nct id: NCT04471779
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will assess the psychosocial and behavioral impacts of receiving Alzheimer's
      disease genetic risk assessment incorporating APOE genotypes among Latinos in northern
      Manhattan. The investigators will conduct a longitudinal, community-based study with a mixed
      methods design. Participants will be randomized to learn about their lifetime risk of
      late-onset Alzheimer's disease (AD) based either on (a) Latino ethnicity and family history
      alone (genotype nondisclosure group), or (b) the same factors plus APOE genotype (genotype
      disclosure group). Responses will be evaluated at 6 weeks, 9 months, and 15 months after risk
      assessment. In the quantitative component of the study, the investigators will assess
      psychosocial outcomes, memory test performance, and health-related behaviors. In the
      qualitative component of the study, the investigators will investigate the lived experience
      of receiving personal AD risk information, using a stress and coping theoretical framework.
Apolipoprotein E (APOE) is the strongest genetic predictor of risk for late-onset Alzheimer's
      disease (AD). Given the high level of interest in genetic testing, the demand for predictive
      testing for APOE will surely increase. Improved understanding of the impacts of testing,
      sources of variability in response, and inclusion of diverse samples are critical for
      informing methods to promote safe and effective disclosure of AD genetic risk information.

      As with other diseases, previous research on AD, a devastating and incurable illness, has
      found little significant or sustained distress in response to genetic susceptibility testing
      for APOE, even among persons who learn they are at elevated risk. These surprising findings,
      which run counter to the experience of many clinicians, may be related to limitations in the
      methods of previous studies. Most previous studies primarily enrolled well-educated
      Caucasians with a family history, who were strongly motivated to pursue genetic risk
      information. Further, most studies assessed impacts primarily through standardized measures
      of depression and anxiety, which may not capture the kinds of distress experienced or coping
      strategies that might blunt or mask distress. Qualitative research shows that receipt of
      genetic information can have important psychosocial effects not well captured through
      standardized measures. Also, in one study, people with a high-risk gene test for APOE
      performed worse on memory tests if they were informed about the results than if they were not
      informed, suggesting that other impact measures are needed.

      Another important limitation of prior work is that it has lacked representation of ethnic
      minority groups. Latinos are the second largest U.S. ethnic group, comprising about 18% of
      the population, yet no previous study has investigated the impacts of receiving AD genetic
      risk information among Latinos. While AD incidence rates may vary among Latino subgroups,
      data from the Washington Heights-Inwood Columbia Aging Project (WHICAP), a study in northern
      Manhattan, indicate that they are about twice as high among Caribbean Hispanics (primarily
      Dominicans) as among persons of European ancestry.

      In this study, the investigators will improve understanding of the impacts of receiving
      personal AD genetic risk information and the factors that influence adjustment to such
      information among Latinos who live in the same communities studied in WHICAP.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators estimate that 2171 people will participate in the Baseline Survey, of whom 400 will be included in the follow-up study. Half of those in the follow-up study will be randomized to receive information about their risk of Alzheimer's disease based on Latino ethnicity, family history, and APOE genotype, and half will be randomized to receive information about their risk based on ethnicity and family history alone.
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: Persons conducting follow-up surveys via computer-assisted telephone interviews will be masked with respect to participant randomization group
measure: Impact of Genetic Testing in AD (IGT-AD)
time frame: 6 weeks after risk evaluation
description: 16-item scale that assesses the impact of test result disclosure across both distress and positive domains. The scale will be modified to anchor it to "risk assessment" rather than genetic test results to enable it to be used in both disclosure groups. Each item scored 0 (never), 1 (rarely) 3 (sometimes) 5 (often). Values are summed; higher total indicates worse outcome (greater adverse impact). Scale range: 0-80.
measure: Impact of Genetic Testing in AD (IGT-AD)
time frame: 9 months after risk evaluation
description: 16-item scale that assesses the impact of test result disclosure across both distress and positive domains. The scale will be modified to anchor it to "risk assessment" rather than genetic test results to enable it to be used in both disclosure groups. Each item scored 0 (never), 1 (rarely) 3 (sometimes) 5 (often). Values are summed; higher total indicates worse outcome (greater adverse impact). Scale range: 0-80.
measure: Impact of Genetic Testing in AD (IGT-AD)
time frame: 15 months after risk evaluation
description: 16-item scale that assesses the impact of test result disclosure across both distress and positive domains. The scale will be modified to anchor it to "risk assessment" rather than genetic test results to enable it to be used in both disclosure groups. Each item scored 0 (never), 1 (rarely) 3 (sometimes) 5 (often). Values are summed; higher total indicates worse outcome (greater adverse impact). Scale range: 0-80.
measure: Impact of Event Scale-Revised
time frame: 6 weeks after risk evaluation
description: 22-item scale to assess subjective distress caused by traumatic events. Each item scored on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscales can be calculated for Intrusion, Avoidance, and Hyperarousal. The authors recommend using means instead of summed scores; higher mean score indicates worse outcome (greater impact). Scale range: 0-4.
measure: Impact of Event Scale-Revised
time frame: 9 months after risk evaluation
description: 22-item scale to assess subjective distress caused by traumatic events. Each item scored on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscales can be calculated for Intrusion, Avoidance, and Hyperarousal. The authors recommend using means instead of summed scores; higher mean score indicates worse outcome (greater impact). Scale range: 0-4.
measure: Impact of Event Scale-Revised
time frame: 15 months after risk evaluation
description: 22-item scale to assess subjective distress caused by traumatic events. Each item scored on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscales can be calculated for Intrusion, Avoidance, and Hyperarousal. The authors recommend using means instead of summed scores; higher mean score indicates worse outcome (greater impact). Scale range: 0-4.
measure: Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)
time frame: Baseline and 6 weeks after risk evaluation
description: 15-20 minute test of cognitive differences in normal aging. Composite score (the average of standardized z-scores for six measures: immediate memory, delayed memory, working memory, verbal fluency, speed, and reasoning. Lower scores indicate worse outcome (worse memory performance). Range of scale values: -1 to +1.
measure: Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)
time frame: Baseline and 9 months after risk evaluation
description: 15-20 minute test of cognitive differences in normal aging. Composite score (the average of standardized z-scores for six measures: immediate memory, delayed memory, working memory, verbal fluency, speed, and reasoning. Lower scores indicate worse outcome (worse memory performance). Range of scale values: -1 to +1.
measure: Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)
time frame: Baseline and 15 months after risk evaluation
description: 15-20 minute test of cognitive differences in normal aging. Composite score (the average of standardized z-scores for six measures: immediate memory, delayed memory, working memory, verbal fluency, speed, and reasoning. Lower scores indicate worse outcome (worse memory performance). Range of scale values: -1 to +1.
measure: Change in Score on the Metamemory in Adulthood Questionnaire-Revised
time frame: Baseline and 6 weeks after risk evaluation
description: 20-item test of subjective memory. Each item measured on a 5-point Likert scale from 1 (agree strongly) to 5 (disagree strongly). Lower scores indicate worse outcome (worse subjective memory functioning and more decline in memory across time). Scale range: 20-100.
measure: Change in Score on the Metamemory in Adulthood Questionnaire-Revised
time frame: Baseline and 9 months after risk evaluation
description: 20-item test of subjective memory. Each item measured on a 5-point Likert scale from 1 (agree strongly) to 5 (disagree strongly). Lower scores indicate worse outcome (worse subjective memory functioning and more decline in memory across time). Scale range: 20-100.
measure: Change in Score on the Metamemory in Adulthood Questionnaire-Revised
time frame: Baseline and 15 months after risk evaluation
description: 20-item test of subjective memory. Each item measured on a 5-point Likert scale from 1 (agree strongly) to 5 (disagree strongly). Lower scores indicate worse outcome (worse subjective memory functioning and more decline in memory across time). Scale range: 20-100.
measure: Change in Score on Patient Health Questionnaire-9 (PHQ-9)
time frame: Baseline and 6 weeks after risk evaluation
description: 9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.
measure: Change in Score on Patient Health Questionnaire-9 (PHQ-9)
time frame: Baseline and 9 months after risk evaluation
description: 9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.
measure: Change in Score on Patient Health Questionnaire-9 (PHQ-9)
time frame: Baseline and 15 months after risk evaluation
description: 9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.
measure: Change in Score on the General Anxiety Disorder-7 (GAD-7)
time frame: Baseline and 6 weeks after risk evaluation
description: 7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.
measure: Change in Score on the General Anxiety Disorder-7 (GAD-7)
time frame: Baseline and 9 months after risk evaluation
description: 7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.
measure: Change in Score on the General Anxiety Disorder-7 (GAD-7)
time frame: Baseline and 15 months after risk evaluation
description: 7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.
measure: Change in Perceived Threat of AD
time frame: Baseline and 6 weeks after risk evaluation
description: 7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.
measure: Change in Perceived Threat of AD
time frame: Baseline and 9 months after risk evaluation
description: 7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.
measure: Change in Perceived Threat of AD
time frame: Baseline and 15 months after risk evaluation
description: 7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.
measure: Health-related behavior changes
time frame: 6 weeks after risk evaluation
description: 22 items, with each item answered yes (1) or no (0). Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).
measure: Health-related behavior changes
time frame: 9 months after risk evaluation
description: 22 items, with each item answered yes (1) or no (0). Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).
measure: Health-related behavior changes
time frame: 15 months after risk evaluation
description: 22 items, with each item answered yes (1) or no (0). Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).
measure: Recall/understanding of results
time frame: 6 weeks after risk evaluation
description: 5 questions will be asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.
measure: Recall/understanding of results
time frame: 9 months after risk evaluation
description: 5 questions will be asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.
measure: Recall/understanding of results
time frame: 15 months after risk evaluation
description: 5 questions will be asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.
arm group label: Disclosure
arm group type: Experimental
description: Participants will be given information about their risk of Alzheimer's disease based on Latino ethnicity, family history of Alzheimer's disease, and their APOE genotype.
arm group label: Non-disclosure
arm group type: No Intervention
description: Participants will be given information about their risk of Alzheimer's disease based on Latino ethnicity and family history of Alzheimer's disease alone.
intervention type: Other
intervention name: Disclosure of APOE genotype
description: Information about risk of Alzheimer's disease will be given to participants based on their APOE genotypes, in addition to Latino ethnicity and family history.
arm group label: Disclosure
criteria: 
gender: All
minimum age: 40 Years
maximum age: 64 Years
healthy volunteers: No
last name: Ruth Ottman, PhD
role: Principal Investigator
affiliation: Columbia University
last name: Ruth Ottman, PhD
phone: 212-305-7892
email: ro6@cumc.columbia.edu
last name: Karolynn Siegel, PhD
phone: 212-304-5578
email: ks420@cumc.columbia.edu
facility: 
status: Recruiting
country: United States
citation: Molinuevo JL, Pintor L, Peri JM, Lleo A, Oliva R, Marcos T, Blesa R. Emotional reactions to predictive testing in Alzheimer's disease and other inherited dementias. Am J Alzheimers Dis Other Demen. 2005 Jul-Aug;20(4):233-8. doi: 10.1177/153331750502000408.
PMID: 16136847
citation: Heshka JT, Palleschi C, Howley H, Wilson B, Wells PS. A systematic review of perceived risks, psychological and behavioral impacts of genetic testing. Genet Med. 2008 Jan;10(1):19-32. doi: 10.1097/GIM.0b013e31815f524f.
PMID: 18197053
citation: Green RC, Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Brown T, Eckert SL, Butson M, Sadovnick AD, Quaid KA, Chen C, Cook-Deegan R, Farrer LA; REVEAL Study Group. Disclosure of APOE genotype for risk of Alzheimer's disease. N Engl J Med. 2009 Jul 16;361(3):245-54. doi: 10.1056/NEJMoa0809578.
PMID: 19605829
citation: Bemelmans SA, Tromp K, Bunnik EM, Milne RJ, Badger S, Brayne C, Schermer MH, Richard E. Psychological, behavioral and social effects of disclosing Alzheimer's disease biomarkers to research participants: a systematic review. Alzheimers Res Ther. 2016 Nov 10;8(1):46. doi: 10.1186/s13195-016-0212-z.
PMID: 27832826
citation: Vos J, van Asperen CJ, Oosterwijk JC, Menko FH, Collee MJ, Gomez Garcia E, Tibben A. The counselees' self-reported request for psychological help in genetic counseling for hereditary breast/ovarian cancer: not only psychopathology matters. Psychooncology. 2013 Apr;22(4):902-10. doi: 10.1002/pon.3081. Epub 2012 Jun 27.
PMID: 22740372
citation: Gooding HC, Linnenbringer EL, Burack J, Roberts JS, Green RC, Biesecker BB. Genetic susceptibility testing for Alzheimer disease: motivation to obtain information and control as precursors to coping with increased risk. Patient Educ Couns. 2006 Dec;64(1-3):259-67. doi: 10.1016/j.pec.2006.03.002. Epub 2006 Jul 21.
PMID: 16860524
citation: Zallen DT. "Well, good luck with that": reactions to learning of increased genetic risk for Alzheimer disease. Genet Med. 2018 Nov;20(11):1462-1467. doi: 10.1038/gim.2018.13. Epub 2018 Mar 8.
PMID: 29517767
citation: Lineweaver TT, Bondi MW, Galasko D, Salmon DP. Effect of knowledge of APOE genotype on subjective and objective memory performance in healthy older adults. Am J Psychiatry. 2014 Feb;171(2):201-8. doi: 10.1176/appi.ajp.2013.12121590.
PMID: 24170170
citation: Aviles-Santa ML, Heintzman J, Lindberg NM, Guerrero-Preston R, Ramos K, Abraido-Lanza AL, Bull J, Falcon A, McBurnie MA, Moy E, Papanicolaou G, Pina IL, Popovic J, Suglia SF, Vazquez MA. Personalized medicine and Hispanic health: improving health outcomes and reducing health disparities - a National Heart, Lung, and Blood Institute workshop report. BMC Proc. 2017 Oct 3;11(Suppl 11):11. doi: 10.1186/s12919-017-0079-4. eCollection 2017.
PMID: 29149222
citation: Mehta KM, Yeo GW. Systematic review of dementia prevalence and incidence in United States race/ethnic populations. Alzheimers Dement. 2017 Jan;13(1):72-83. doi: 10.1016/j.jalz.2016.06.2360. Epub 2016 Sep 4.
PMID: 27599209
citation: Tang MX, Maestre G, Tsai WY, Liu XH, Feng L, Chung WY, Chun M, Schofield P, Stern Y, Tycko B, Mayeux R. Relative risk of Alzheimer disease and age-at-onset distributions, based on APOE genotypes among elderly African Americans, Caucasians, and Hispanics in New York City. Am J Hum Genet. 1996 Mar;58(3):574-84.
PMID: 8644717
citation: Tang MX, Stern Y, Marder K, Bell K, Gurland B, Lantigua R, Andrews H, Feng L, Tycko B, Mayeux R. The APOE-epsilon4 allele and the risk of Alzheimer disease among African Americans, whites, and Hispanics. JAMA. 1998 Mar 11;279(10):751-5. doi: 10.1001/jama.279.10.751.
PMID: 9508150
citation: Gurland BJ, Wilder DE, Lantigua R, Stern Y, Chen J, Killeffer EH, Mayeux R. Rates of dementia in three ethnoracial groups. Int J Geriatr Psychiatry. 1999 Jun;14(6):481-93.
PMID: 10398359
citation: Tang MX, Cross P, Andrews H, Jacobs DM, Small S, Bell K, Merchant C, Lantigua R, Costa R, Stern Y, Mayeux R. Incidence of AD in African-Americans, Caribbean Hispanics, and Caucasians in northern Manhattan. Neurology. 2001 Jan 9;56(1):49-56. doi: 10.1212/wnl.56.1.49.
PMID: 11148235
citation: Grubs RE, Parker LS, Hamilton R. Subtle psychosocial sequelae of genetic test results. Current Genetic Medicine Reports 2014;2:242-249.
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Ruth Ottman
investigator title: Professor of Epidemiology
mesh term: Alzheimer Disease
sharing ipd: Yes
ipd description: De-identified data from surveys collected in the study will be made available from the PIs, after acceptance for publication of the primary analyses of the survey data, to qualified researchers who sign a data user agreement as described below. The investigators will provide documentation of all survey data (variable names, variable formats, variable and value labels) to accompany the data, and will share the actual survey instruments upon request. Because interview transcripts can be highly identifying, they will not be shared. However, the codebooks and interview guides will be available from the PIs, after acceptance for publication of the primary analyses of the interviews, to qualified users as described below.
ipd info type: Study Protocol
ipd info type: Analytic Code
ipd time frame: After acceptance for publication of the primary analyses of the study.
ipd access criteria: Data will be available to users only under a data user agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Requests for data must be in writing and addressed to the co-PIs. We will create a data request form that will include investigator affiliation, contact information and a brief description of the project, including specific aims, study design, characteristics of the data requested, and analysis plans. Applications for data use will be reviewed by the co-PIs and a data use committee composed of the other co-investigators. Approval will be contingent upon institutional review board (IRB) approval for the proposed data analysis from the institution of the investigator requesting the data.