Information About Alzheimer's Disease for Latinos in New York City (IDEAL)

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.

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.

Persons conducting follow-up surveys via computer-assisted telephone interviews will be masked with respect to participant randomization group

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.

Participants will be given information about their risk of Alzheimer's disease based on Latino ethnicity and family history of Alzheimer's disease alone.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

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).

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.

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.

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.

Inclusion Criteria: self-identified as Latino or Hispanic age 40-64 years current residence in target neighborhoods: Washington Heights, Inwood, Hamilton Heights, Central Harlem, East Harlem, Morningside Heights, Manhattanville, or Striver's Row, New York Exclusion Criteria: does not self-identify as Latino does not reside in target neighborhoods not in applicable age range has Alzheimer's disease previously tested for APOE has a family history consistent with autosomal dominant, early onset Alzheimer's disease has a positive screen for suicidality in Baseline Survey (any response other than "not at all" to PHQ-9 item, "thoughts that you would be better off dead or of hurting yourself in some way")

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.

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.

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