Genetic Risk Information for Alzheimer's Disease

(IDEAL Trial)

Overseen By Karolynn Siegel, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Non-Latino, Alzheimer's, Suicidality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

374 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Disclosure of APOE genotype for Alzheimer's disease?

Research shows that people who learn about their APOE genotype and their risk for Alzheimer's disease are more likely to change their health behaviors, even though there are no proven preventive measures for Alzheimer's. This suggests that knowing one's genetic risk can motivate individuals to take proactive steps in managing their health. ^{1 2 3 4 5}

Is it safe to disclose APOE genotype information for Alzheimer's risk?

Research shows that disclosing APOE genotype information to people who are not showing symptoms of Alzheimer's is generally safe. Studies have looked at how people react to learning their genetic risk, and while it can influence their health behaviors, it does not appear to cause significant harm. ^{1 3 6 7 8}

How does this treatment differ from other Alzheimer's disease treatments?

This treatment is unique because it involves disclosing genetic risk information, specifically the APOE genotype, to individuals to help them understand their risk of developing Alzheimer's disease. Unlike traditional treatments that focus on managing symptoms, this approach aims to influence health behaviors by providing personalized risk assessments, even though there are no proven preventive measures for Alzheimer's disease. ^{1 3 4 5 9}

What is the purpose of this trial?

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.

Research Team

Ruth Ottman, PhD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for Latinos aged 40-64 living in specific neighborhoods of northern Manhattan who have not been tested for APOE. It's not open to those with Alzheimer's, a family history of early onset Alzheimer's, or current suicidal thoughts.

Inclusion Criteria

You currently live in specific neighborhoods in New York City including Washington Heights, Inwood, Hamilton Heights, Central Harlem, East Harlem, Morningside Heights, Manhattanville, or Striver's Row.

I am between 40 and 64 years old.

You consider yourself to be Latino or Hispanic.

Exclusion Criteria

I have been tested for the APOE gene.

I have been diagnosed with Alzheimer's disease.

My family has a history of early Alzheimer's that can be passed down.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Risk Assessment

Participants are assessed for their risk of Alzheimer's disease based on Latino ethnicity, family history, and potentially APOE genotype

1 week

1 visit (in-person)

Follow-up

Participants are monitored for psychosocial and behavioral impacts at 6 weeks, 9 months, and 15 months after risk assessment

15 months

3 visits (in-person)

Treatment Details

Interventions

• Disclosure of APOE genotype

Trial Overview The study examines the effects on Latinos of learning their genetic risk for late-onset Alzheimer's Disease. Participants will either be told their risk based on ethnicity and family history alone or with added APOE genotype information.

Participant Groups

Group I: Disclosure Experimental Treatment 1 Intervention

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.

Group II: Non-disclosure Active Control 1 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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Disclosure of APOE genotype for risk of Alzheimer's disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Disclosing the disclosure: factors associated with communicating the results of genetic susceptibility testing for Alzheimer's disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Health behavior changes after genetic risk assessment for Alzheimer disease: The REVEAL Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Genetic risk assessment for adult children of people with Alzheimer's disease: the Risk Evaluation and Education for Alzheimer's Disease (REVEAL) study. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of APOE Genotyping and Disclosure in Cognitively Normal Volunteers From the Butler Alzheimer's Prevention Registry. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Using Direct-to-Consumer Genetic Testing Results to Accelerate Alzheimer Disease Clinical Trial Recruitment. [2023]

8. Denmark pubmed.ncbi.nlm.nih.gov

Using Alzheimer's disease as a model for genetic risk disclosure: implications for personal genomics. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Factors affecting recall of different types of personal genetic information about Alzheimer's disease risk: the REVEAL study. [2021]