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Genetic Risk Information for Alzheimer's Disease (IDEAL Trial)

N/A

Waitlist Available

Led By Ruth Ottman, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 40-64 years

Be between 18 and 65 years old

Must not have

Has Alzheimer's disease

Has a family history consistent with autosomal dominant, early onset Alzheimer's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months after risk evaluation

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the impacts of receiving information on one's genetic risk for Alzheimer's disease among Latinos in northern Manhattan.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There are no direct physical side effects from participating as it involves receiving information about personal genetic risk. However, there may be psychological impacts from knowing one’s potential risk which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Alzheimer's disease.

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

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I am not within the required age range for the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 15 months after risk evaluation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 15 months after risk evaluation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 15 months after risk evaluation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)

Change in Score on the Metamemory in Adulthood Questionnaire-Revised

Impact of Event Scale-Revised

+1 more

Secondary study objectives

Change in Perceived Threat of AD

Change in Score on Patient Health Questionnaire-9 (PHQ-9)

Change in Score on the General Anxiety Disorder-7 (GAD-7)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DisclosureExperimental Treatment1 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-disclosureActive Control1 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.

0 / 4Eligibility criteria met