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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how knowing genetic risk for Alzheimer's affects emotions and actions, focusing on Latinos in northern Manhattan. Participants will learn their Alzheimer's risk based on Latino ethnicity and family history, with some also discovering their APOE gene status, which can influence Alzheimer's risk. Researchers will periodically assess how this information impacts feelings, memory, and health habits. The trial seeks Latino or Hispanic individuals living in specific Manhattan neighborhoods who have not previously been tested for the APOE gene. As an unphased trial, this study offers a unique opportunity to understand personal genetic risk and its impact on lifestyle choices.

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 prior data suggests that this genetic risk assessment is safe?

Research has shown that informing individuals about their APOE gene type, linked to Alzheimer's disease risk, is generally safe. One study found that sharing these genetic results did not cause major short-term mental health issues. Another study found that discussing APOE results over the phone was safe and even helpful for those seeking to understand their risk. Overall, evidence suggests that learning about the APOE gene type is psychologically safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how genetic information can influence our understanding of Alzheimer's disease risk, particularly through the disclosure of the APOE genotype. Unlike current standard care options that focus on managing symptoms or slowing progression with medications, this approach offers personalized insights by incorporating genetic data. This method could lead to more tailored prevention strategies and empower individuals with knowledge about their genetic predisposition, potentially opening new avenues for early intervention and lifestyle adjustments.

What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?

Research has shown that sharing information about the APOE gene, linked to Alzheimer's risk, helps people better understand their risk factors. In this trial, participants in the "Disclosure" arm will receive information about their Alzheimer's disease risk based on Latino ethnicity, family history, and APOE genotype. Studies indicate that participants often remember this risk information even a year later. Initial findings suggest that knowing one's APOE status doesn't cause significant short-term worry. Instead, it helps people understand their Alzheimer's risk based on their genes. Understanding these risks can guide individuals in making informed health choices. Overall, learning about the APOE gene aids participants in understanding their Alzheimer's risk without causing unnecessary stress. ^{1 2 6 7 8}

Who Is on the Research Team?

Ruth Ottman, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2778270/

Disclosure of APOE Genotype for Risk of Alzheimer's ... Conclusions. The disclosure of APOE genotyping results to adult children of patients with Alzheimer's disease did not result in significant short-term ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1098360021022942

Effectiveness of a condensed protocol for disclosing APOE ... Both groups showed improvement from baseline in Alzheimer disease risk knowledge (e.g., understanding the magnitude of apolipoprotein E genotype effect on risk) ...

3. nature.com nature.com/articles/gim2006123

Recall of disclosed Apolipoprotein E genotype and lifetime ... Results: At six weeks and one year post-disclosure, 59% and 48% of participants, respectively, recalled their lifetime risk estimate, and 69% and 63% recalled ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.70016

A randomized clinical trial of APOE genotype disclosure for ... IDEAL Study is a randomized clinical trial investigating the psychosocial, behavioral, and cognitive impacts of apolipoprotein E (APOE) genotype disclosure

5. researchgate.net researchgate.net/publication/26674259_Disclosure_of_APOE_Genotype_for_Risk_of_Alzheimer's_Disease

(PDF) Disclosure of APOE Genotype for Risk of Alzheimer's ... The disclosure of APOE genotyping results to adult children of patients with Alzheimer's disease did not result in significant short-term ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1098360021019110

A randomized controlled trial of disclosing genetic risk ... Telephone disclosure of APOE results and risk for Alzheimer disease is generally safe and helps providers meet demands for services.

7. bu.edu bu.edu/alzresearch/files/pdf/Green_NEJMREVEALIpaper_final6.pdf

APOE Genotype Disclosure for Risk of Alzheimer's Disease We report results of a clinical trial to evaluate the benefits and safety of APOE genotype ... These data support the psychological safety of disclosing genetic ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01434667?term=AREA%5BBasicSearch%5D(Alzheimer's)&rank=6

Risk Evaluation and Education for Alzheimer's Disease ... Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype. Subjects with MCI ...