Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04471779
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2020-07-09
Brief Title:
Information About Alzheimers Disease for Latinos in New York City
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
The IDEAL Study Information About Alzheimers Disease for Latinos in New York City
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEAL
Brief Summary:
This study will assess the psychosocial and behavioral impacts of receiving Alzheimers 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 Alzheimers 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:
Apolipoprotein E APOE is the strongest genetic predictor of risk for late-onset Alzheimers 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 US 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
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 US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG062528 | NIH | None | httpsreporternihgovquickSearchR01AG062528 |