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

Columbia University

Status: Completed

Conditions: Alzheimer Disease

Treatments: Other: Disclosure of APOE genotype

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04471779

AAAR8269

R01AG062528 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 374 patients

Sex: All

Ages: 40 to 64 years old

Volunteers: No Healthy Volunteers

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")

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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374 participants in 2 patient groups

Disclosure

Experimental group

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.

Treatment:

Other: Disclosure of APOE genotype

Non-disclosure

No Intervention group

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.