NCT04471779: IDEAL

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

Completed NA Last updated 17 November 2025

What this trial tests

NA trial testing Disclosure of APOE genotype in Alzheimer Disease in 374 participants. Completed in 3 October 2025.

Timeline

13 August 2021

Primary endpoint
3 October 2025

3 October 2025

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	374
Start date	13 August 2021
Primary completion	3 October 2025
Estimated completion	3 October 2025
Sites	1 location across United States

Drugs / interventions tested

• Disclosure of APOE genotype

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Columbia University

Who can join

Adults 40 to 64, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Designing and implementing the IDEAL Study: A randomized clinical trial of <i>APOE</i> genotype disclosure for late-onset Alzheimer's disease in an urban Latino population.
   Wetmore JB, Rodriguez S, Diaz Caro D, Cabán M, et al · · 2024 · cited 6× · PMID 39748836 · DOI 10.1002/trc2.70016
2. Impact of learning APOE genotype on cognitively unimpaired adults: a pre-screening cohort study of the Alzheimer's Prevention Initiative Generation Study 1.
   Langbaum JB, Bradbury AR, Egleston BL, McCarty Wood E, et al · · 2025 · cited 1× · PMID 41319675 · DOI 10.1016/j.lanhl.2025.100778
3. Addressing Disparities in Alzheimer's Disease-Related Healthcare Through Understanding Factors Contributing to Perceived Vulnerability Among Latinos in Northern Manhattan: A Qualitative Report.
   Meng A, Cabán M, Tran E, Wetmore JB, et al · · 2026 · cited 1× · PMID 40195275 · DOI 10.1007/s40615-025-02409-6
4. Exploring immediate responses to <i>APOE</i><b>ε</b>4/ε4 genotype and Alzheimer's disease risk disclosure in Latinos.
   Diaz Caro D, Rodriguez S, Uhlmann WR, Goldman JS, et al · · 2026 · PMID 41906765 · DOI 10.1177/13872877261435633
5. Family history, perceived risk, and perceived threat of Alzheimer's disease among Latino residents of northern Manhattan.
   Murphy EJ, Wetmore JB, Cabán M, Siegel K, et al · · 2026 · PMID 41767158 · DOI 10.1002/dad2.70292
6. Planning for the future following receipt of Alzheimer's disease risk estimate among Latinos in New York City.
   Cabán M, Tran E, Meng A, Wetmore JB, et al · · 2025 · PMID 40776633 · DOI 10.1177/13872877251365571
7. Knowledge and Beliefs About Medical and Non-Medical Interventions to Control Alzheimer's Disease Among Latinos in New York City.
   Tran E, Cabán M, Meng A, Wetmore JB, et al · · 2025 · PMID 40627435 · DOI 10.1002/gps.70128
8. Exploring the Immediate Impact of APOE ε4ε4 Genotype Disclosure among Latinos
   Caro D, Rodriguez S, Wetmore J, Godinez J, et al · · 2024