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

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months after risk evaluation

Awards & highlights

IDEAL Trial 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.Check my eligibility

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.See study design

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.

IDEAL Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 40 and 64 years old.

IDEAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months after risk evaluation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months after risk evaluation

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

IDEAL 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,446,859 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,485 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity for participants in this clinical trial?

"Affirmative. Clinicaltrials.gov information demonstrates this medical experiment is actively seeking out participants, which was posted on June 29th 2021 and recently modified on January 19th 2022. The study requires 456 patients from a single clinical centre to take part in the trial."

Answered by AI

Is there an age criterion for participation in the experiment?

"The trial is recruiting people between the ages of 40 and 64. There are 23 separate studies for individuals under 18, while a further 542 trials focus on seniors over 65 years old."

Answered by AI

What is the primary purpose of this clinical research?

"The primary objective of this trial, to be evaluated over an 18 month period after baseline assessment is the Impact of Genetic Testing in AD (IGT-AD). Secondary outcomes include Change in Perceived Threat of AD which is measured by a 7-item scale ranging from 1 to 5 that gauges one's anxiety towards developing Alzheimer's disease. Additionally, patient health will be assessed through the Patient Health Questionnaire-9 (PHQ-9) which has 9 items rated on a 0 - 3 spectrum indicating frequency with which symptoms occurred during 2 weeks prior. Lastly, recall/understanding results are determined through five questions answered either correctly or incorrectly"

Answered by AI

Are any additional research participants being accepted for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this trial, initially posted on June 29th 2021 is actively recruiting patients from a single site. 456 people are required for the study's completion and it was recently revised in January 19th 2022."

Answered by AI