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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The IDEAL Study: Information About Alzheimer's Disease for Latinos in New York City

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Disclosure of APOE genotype


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators estimate that 2171 people will participate in the Baseline Survey, of whom 400 will be randomized and 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disclosure<br>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. | Other: Disclosure of APOE genotype<br>* 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.<br>|
| No Intervention: Non-disclosure<br>Participants will be given information about their risk of Alzheimer's disease based on Latino ethnicity and family history of Alzheimer's disease alone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Genetic Testing in AD (IGT-AD) | 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. | 6 weeks after risk evaluation | 
| Impact of Genetic Testing in AD (IGT-AD) | 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. | 9 months after risk evaluation | 
| Impact of Genetic Testing in AD (IGT-AD) | 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. | 15 months after risk evaluation | 
| Impact of Event Scale-Revised | 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. | 6 weeks after risk evaluation | 
| Impact of Event Scale-Revised | 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. | 9 months after risk evaluation | 
| Impact of Event Scale-Revised | 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 months after risk evaluation | 
| Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT) | 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. | Baseline and 6 weeks after risk evaluation | 
| Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT) | 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. | Baseline and 9 months after risk evaluation | 
| Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT) | 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. | Baseline and 15 months after risk evaluation | 
| Change in Score on the Metamemory in Adulthood Questionnaire-Revised | 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. | Baseline and 6 weeks after risk evaluation | 
| Change in Score on the Metamemory in Adulthood Questionnaire-Revised | 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. | Baseline and 9 months after risk evaluation | 
| Change in Score on the Metamemory in Adulthood Questionnaire-Revised | 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. | Baseline and 15 months after risk evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score on Patient Health Questionnaire-9 (PHQ-9) | 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. | Baseline and 6 weeks after risk evaluation | 
| Change in Score on Patient Health Questionnaire-9 (PHQ-9) | 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. | Baseline and 9 months after risk evaluation | 
| Change in Score on Patient Health Questionnaire-9 (PHQ-9) | 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. | Baseline and 15 months after risk evaluation | 
| Change in Score on the General Anxiety Disorder-7 (GAD-7) | 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. | Baseline and 6 weeks after risk evaluation | 
| Change in Score on the General Anxiety Disorder-7 (GAD-7) | 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. | Baseline and 9 months after risk evaluation | 
| Change in Score on the General Anxiety Disorder-7 (GAD-7) | 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. | Baseline and 15 months after risk evaluation | 
| Change in Perceived Threat of AD | 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. | Baseline and 6 weeks after risk evaluation | 
| Change in Perceived Threat of AD | 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. | Baseline and 9 months after risk evaluation | 
| Change in Perceived Threat of AD | 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. | Baseline and 15 months after risk evaluation | 
| Health-related behavior changes | 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). | 6 weeks after risk evaluation | 
| Health-related behavior changes | 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). | 9 months after risk evaluation | 
| Health-related behavior changes | 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). | 15 months after risk evaluation | 
| Recall/understanding of results | 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. | 6 weeks after risk evaluation | 
| Recall/understanding of results | 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. | 9 months after risk evaluation | 
| Recall/understanding of results | 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. | 15 months after risk evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Latinos, New York (NY), Genetics