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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 belowSelect...
I am between 40 and 64 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with Alzheimer's disease.
Select...
My family has a history of early Alzheimer's that can be passed down.
Select...
I am not within the required age range for the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 9 months after risk evaluation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 9 months after risk evaluation
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 moreSecondary 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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility 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.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 have indicated in the survey that you have thoughts of hurting yourself or feeling like you would be better off dead.You consider yourself to be Latino or Hispanic.I am not within the required age range for the trial.You do not live in the specified areas.
Research Study Groups:
This trial has the following groups:- Group 1: Non-disclosure
- Group 2: Disclosure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.