Information About Alzheimer's Disease for Latinos in New York City
NCT ID: NCT04471779
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
374 participants
INTERVENTIONAL
2021-08-13
2025-10-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Disclosure
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.
Disclosure of APOE genotype
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.
Non-disclosure
Participants will be given information about their risk of Alzheimer's disease based on Latino ethnicity and family history of Alzheimer's disease alone.
No interventions assigned to this group
Interventions
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Disclosure of APOE genotype
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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")
40 Years
64 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Columbia University
OTHER
Responsible Party
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Ruth Ottman
Professor of Epidemiology
Principal Investigators
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Ruth Ottman, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Irving Medical Center
New York, New York, United States
Countries
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References
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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.
Grubs RE, Parker LS, Hamilton R. Subtle psychosocial sequelae of genetic test results. Current Genetic Medicine Reports 2014;2:242-249.
Caban M, Tran E, Meng A, Wetmore JB, Ottman R, Siegel K. Planning for the future following receipt of Alzheimer's disease risk estimate among Latinos in New York City. J Alzheimers Dis. 2025 Oct;107(3):1226-1239. doi: 10.1177/13872877251365571. Epub 2025 Aug 8.
Tran E, Caban M, Meng A, Wetmore JB, Ottman R, Siegel K. Knowledge and Beliefs About Medical and Non-Medical Interventions to Control Alzheimer's Disease Among Latinos in New York City. Int J Geriatr Psychiatry. 2025 Jul;40(7):e70128. doi: 10.1002/gps.70128.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Meng A, Caban M, Tran E, Wetmore JB, Ottman R, Siegel K. Addressing Disparities in Alzheimer's Disease-Related Healthcare Through Understanding Factors Contributing to Perceived Vulnerability Among Latinos in Northern Manhattan: A Qualitative Report. J Racial Ethn Health Disparities. 2025 Apr 7:10.1007/s40615-025-02409-6. doi: 10.1007/s40615-025-02409-6. Online ahead of print.
Other Identifiers
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AAAR8269
Identifier Type: -
Identifier Source: org_study_id
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