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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 baseline and 9 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 weeks
Treatment ~ Varies
Follow Up ~baseline and 9 months after risk evaluation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 9 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.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,492 Previous Clinical Trials
2,664,484 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,793 Previous Clinical Trials
28,191,754 Total Patients Enrolled
Ruth Ottman, PhDPrincipal Investigator - Columbia University
Columbia University

Media Library

Disclosure of APOE genotype Clinical Trial Eligibility Overview. Trial Name: NCT04471779 — N/A
Alzheimer's Disease Research Study Groups: Non-disclosure, Disclosure
Alzheimer's Disease Clinical Trial 2023: Disclosure of APOE genotype Highlights & Side Effects. Trial Name: NCT04471779 — N/A
Disclosure of APOE genotype 2023 Treatment Timeline for Medical Study. Trial Name: NCT04471779 — N/A
~81 spots leftby Nov 2025