- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04471779
Information About Alzheimer's Disease for Latinos in New York City (IDEAL)
The IDEAL Study: Information About Alzheimer's Disease for Latinos in New York City
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ruth Ottman, PhD
- Phone Number: 212-305-7892
- Email: ro6@cumc.columbia.edu
Study Contact Backup
- Name: Karolynn Siegel, PhD
- Phone Number: 212-304-5578
- Email: ks420@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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")
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
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No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of Genetic Testing in AD (IGT-AD)
Time Frame: 6 weeks after risk evaluation
|
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)
Time Frame: 9 months after risk evaluation
|
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 Event Scale-Revised
Time Frame: 6 weeks after risk evaluation
|
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
Time Frame: 9 months after risk evaluation
|
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
|
Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)
Time Frame: Baseline and 6 weeks after risk evaluation
|
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)
Time Frame: Baseline and 9 months after risk evaluation
|
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 Metamemory in Adulthood Questionnaire-Revised
Time Frame: Baseline and 6 weeks after risk evaluation
|
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
Time Frame: Baseline and 9 months after risk evaluation
|
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
|
Impact of Genetic Testing in AD (IGT-AD)
Time Frame: 15 months after risk evaluation
|
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
Time Frame: 15 months after risk evaluation
|
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)
Time Frame: Baseline and 15 months after risk evaluation
|
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
Time Frame: Baseline and 15 months after risk evaluation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline and 6 weeks after risk evaluation
|
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.
|
Baseline and 6 weeks after risk evaluation
|
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline and 9 months after risk evaluation
|
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.
|
Baseline and 9 months after risk evaluation
|
Change in Score on the General Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline and 6 weeks after risk evaluation
|
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.
|
Baseline and 6 weeks after risk evaluation
|
Change in Score on the General Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline and 9 months after risk evaluation
|
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.
|
Baseline and 9 months after risk evaluation
|
Health-related behavior changes
Time Frame: 6 weeks after risk evaluation
|
22 items, with each item answered yes (1) or no (0).
Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).
|
6 weeks after risk evaluation
|
Health-related behavior changes
Time Frame: 9 months after risk evaluation
|
22 items, with each item answered yes (1) or no (0).
Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).
|
9 months after risk evaluation
|
Recall/understanding of results
Time Frame: 6 weeks after risk evaluation
|
5 questions will be 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.
|
6 weeks after risk evaluation
|
Recall/understanding of results
Time Frame: 9 months after risk evaluation
|
5 questions will be 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.
|
9 months after risk evaluation
|
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline and 15 months after risk evaluation
|
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.
|
Baseline and 15 months after risk evaluation
|
Change in Score on the General Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline and 15 months after risk evaluation
|
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.
|
Baseline and 15 months after risk evaluation
|
Change in Perceived Threat of AD
Time Frame: Baseline and 6 weeks after risk evaluation
|
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.
|
Baseline and 6 weeks after risk evaluation
|
Change in Perceived Threat of AD
Time Frame: Baseline and 9 months after risk evaluation
|
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.
|
Baseline and 9 months after risk evaluation
|
Change in Perceived Threat of AD
Time Frame: Baseline and 15 months after risk evaluation
|
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.
|
Baseline and 15 months after risk evaluation
|
Health-related behavior changes
Time Frame: 15 months after risk evaluation
|
22 items, with each item answered yes (1) or no (0).
Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).
|
15 months after risk evaluation
|
Recall/understanding of results
Time Frame: 15 months after risk evaluation
|
5 questions will be 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.
|
15 months after risk evaluation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ruth Ottman, PhD, Columbia University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Grubs RE, Parker LS, Hamilton R. Subtle psychosocial sequelae of genetic test results. Current Genetic Medicine Reports 2014;2:242-249.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAR8269
- R01AG062528 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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