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

NCT04471779 | Completed DMC

• 2 other identifiers: AAAR8269R01AG062528
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Latinos; New York (NY); Genetics

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (15)

• Change in Score on Patient Health Questionnaire-9 (PHQ-9)

  Baseline and 6 weeks after risk evaluation

• Change in Score on Patient Health Questionnaire-9 (PHQ-9)

  Baseline and 9 months after risk evaluation

• Change in Score on Patient Health Questionnaire-9 (PHQ-9)

  Baseline and 15 months after risk evaluation

• Change in Score on the General Anxiety Disorder-7 (GAD-7)

  Baseline and 6 weeks after risk evaluation

• Change in Score on the General Anxiety Disorder-7 (GAD-7)

  Baseline and 9 months after risk evaluation

Study Arms (2)

Disclosure

EXPERIMENTAL

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

Non-disclosure

NO INTERVENTION

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

Interventions

Disclosure of APOE genotype OTHER

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.

Disclosure

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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")

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (18)

• 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.

  PMID: 16136847 BACKGROUND

• 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.

  PMID: 18197053 BACKGROUND

• 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.

  PMID: 19605829 BACKGROUND

• 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.

  PMID: 27832826 BACKGROUND

• 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.

  PMID: 22740372 BACKGROUND

• 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.

  PMID: 16860524 BACKGROUND

• 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.

  PMID: 29517767 BACKGROUND

• 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.

  PMID: 24170170 BACKGROUND

• 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.

  PMID: 29149222 BACKGROUND

• 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.

  PMID: 27599209 BACKGROUND

• 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.

  PMID: 8644717 BACKGROUND

• 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.

  PMID: 9508150 BACKGROUND

• 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.

  PMID: 10398359 BACKGROUND

• 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.

  PMID: 11148235 BACKGROUND

• Grubs RE, Parker LS, Hamilton R. Subtle psychosocial sequelae of genetic test results. Current Genetic Medicine Reports 2014;2:242-249.

  BACKGROUND

• 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.

  PMID: 40776633 DERIVED

• 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.

  PMID: 40627435 DERIVED

• 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.

  PMID: 40195275 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ruth Ottman, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Persons conducting follow-up surveys via computer-assisted telephone interviews will be masked with respect to participant randomization group
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 15, 2020
• Study Start: August 13, 2021
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: After acceptance for publication of the primary analyses of the study.
• Access Criteria: 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.

Locations

US (1)