Alzheimer DiseaseIDEALNCT04471779
Information About Alzheimer's Disease for Latinos in New York City
A study testing Disclosure of APOE genotype in people with Alzheimer Disease, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Disclosure of APOE genotype
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 3 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: The IDEAL Study: Information About Alzheimer's Disease for Latinos in New York City
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.
Read the detailed 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.
- Conditions
- Alzheimer Disease
- Being tested
- Disclosure of APOE genotype
- Keywords
- Latinos, New York (NY), Genetics
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disclosure of APOE genotypeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 months after risk evaluation
Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)
The BTACT is a 15 to 20 minute test of cognitive differences in normal aging. It is reported as a composite score (average of standardized z-scores for five measures: immediate memory, delayed memory, working memory, verbal fluency, and speed). A z-score of 0 represents the average score of the study population. A negative z-score indicates a lower-than-average score (worse memory performance), and a positive score indicates a higher-than-average score (better memory performance). Results are shown as change from baseline.
Measured: 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 five measures: immediate memory, delayed memory, working memory, verbal fluency, and speed. A z-score of 0 represents the average score of the study population. A negative z-score indicates a lower-than-average score (worse memory performance), and a positive score indicates a higher-than-average score (better memory performance). Results are shown as change from baseline.
Measured: 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 five measures: immediate memory, delayed memory, working memory, verbal fluency, and speed. A z-score of 0 represents the average score of the study population. A negative z-score indicates a lower-than-average score (worse memory performance), and a positive score indicates a higher-than-average score (better memory performance). Results are shown as change from baseline.
Measured: 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. Results reported as change in score from baseline.
Measured: 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. Results reported as change in score from baseline.
Measured: 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. Results reported as change in score from baseline.
Measured: Baseline and 15 months after risk evaluation
Secondary outcomes (15)
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27. Results shown as difference between score at follow-up and score at baseline.
Measured: Baseline and 6 weeks after risk evaluation
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.
Measured: Baseline and 9 months after risk evaluation
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.
Measured: Baseline and 15 months after risk evaluation
Change in Score on the General Anxiety Disorder-7 (GAD-7)
7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.
Measured: Baseline and 6 weeks after risk evaluation
Change in Score on the General Anxiety Disorder-7 (GAD-7)
7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.
Measured: Baseline and 9 months after risk evaluation
Change in Score on the General Anxiety Disorder-7 (GAD-7)
7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.
Measured: Baseline and 15 months after risk evaluation
Change in Perceived Threat of AD
7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.
Measured: Baseline and 6 weeks after risk evaluation
Change in Perceived Threat of AD
7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.
Measured: Baseline and 9 months after risk evaluation
Change in Perceived Threat of AD
7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.
Measured: Baseline and 15 months after risk evaluation
Number of Health-related Behavior Changes
Scores on a scale measuring the total number of health-related behavior changes, out of 22 possible changes. Each item on questionnaire is scored 0 (no change made in item) or 1 (change made). Total value greater than 0 indicates no change in any of 22 items listed. Higher values indicate better outcome (the participant made one or more changes in diet, exercise, or medications/vitamins in response to receiving AD risk information). Scale range 0-22.
Measured: 6 weeks after risk evaluation
Number of Health-related Behavior Changes
Scores on a scale measuring the total number of health-related behavior changes, out of 22 possible changes. Each item on questionnaire is scored 0 (no change made in item) or 1 (change made). Total value greater than 0 indicates no change in any of 22 items listed. Higher values indicate better outcome (the participant made one or more changes in diet, exercise, or medications/vitamins in response to receiving AD risk information). Scale range 0-22.
Measured: 9 months after risk evaluation
Number of Health-related Behavior Changes
Scores on a scale measuring the total number of health-related behavior changes, out of 22 possible changes. Each item on questionnaire is scored 0 (no change made in item) or 1 (change made). Total value greater than 0 indicates no change in any of 22 items listed. Higher values indicate better outcome (the participant made one or more changes in diet, exercise, or medications/vitamins in response to receiving AD risk information). Scale range 0-22.
Measured: 15 months after risk evaluation
Recall/Understanding of Results
5 questions asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.
Measured: 6 weeks after risk evaluation
Recall/Understanding of Results
5 questions asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.
Measured: 9 months after risk evaluation
Recall/Understanding of Results
5 questions asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.
Measured: 15 months after risk evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start13 Aug 2021
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ruth Ottman, Columbia University
- Investigators
- Ruth Ottman, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471779
- Sponsor's protocol ID
- AAAR8269
- Other IDs
- R01AG062528
- Acronym
- IDEAL
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2020
- Last updated
- 16 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of individual-level data from the IDEAL Study is not permitted due to restrictions in the informed consent. Accordingly, no individual participant-level quantitative data, qualitative interview transcripts, APOE genotype data, or biospecimens will be shared. Aggregate study results and supporting materials necessary to facilitate understanding, transparency, and reproducibility of the study findings will be deposited in a publicly available repository (e.g.,The National Archive of Computerized Data on Aging \[NACDA\]).
Publications
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.
PubMed 16136847Heshka 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.
PubMed 18197053Green 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.
PubMed 19605829Bemelmans 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.
PubMed 27832826Vos 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.
PubMed 22740372Gooding 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.
PubMed 16860524Zallen 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.
PubMed 29517767Lineweaver 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.
PubMed 24170170Aviles-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.
PubMed 29149222Mehta 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.
PubMed 27599209Tang 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.
PubMed 8644717Tang 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.
PubMed 9508150Gurland 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.
PubMed 10398359Tang 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.
PubMed 11148235Grubs RE, Parker LS, Hamilton R. Subtle psychosocial sequelae of genetic test results. Current Genetic Medicine Reports 2014;2:242-249.