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Omega-3 Fatty Acid

DHA Supplementation for Alzheimer's Disease (PreventE4 Trial)

Phase 2
Waitlist Available
Led By Hussein Yassine, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: ≥ 55 and ≤ 80
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

PreventE4 Trial Summary

This trial will help us understand if people with a certain gene are more likely to get Alzheimer's and if taking a certain supplement could help prevent it.

Who is the study for?
This trial is for people aged 55 to 80 who are at risk of Alzheimer's due to factors like obesity, less education, high blood pressure, or high cholesterol. They must have a certain level of memory function and not be diagnosed with dementia or taking omega-3s, anticoagulants, specific Alzheimer's drugs, or abusing substances.Check my eligibility
What is being tested?
The study tests if DHA (an omega-3 fatty acid) delivery to the brain differs in those carrying the APOE ε4 gene variant linked to higher Alzheimer's risk. Participants will either receive DHA supplements or a placebo to see if it affects cognitive decline prevention.See study design
What are the potential side effects?
DHA may cause mild side effects such as fishy aftertaste, stomach upset, or allergic reactions. Placebos typically have no active ingredients but can lead to perceived side effects due to participants' expectations.

PreventE4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 55 and 80 years old.

PreventE4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years 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 cerebrospinal fluid fatty acid levels after the intervention in 184 subjects
Other outcome measures
Change in cognitive measures using the Neuropsychological Outcomes (RBANS) in all 368 participants
Change in functional connectivity using resting state functional MRI in all 368 participants
Change in structural connectivity using MRI in all 368 participants

PreventE4 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DHAExperimental Treatment1 Intervention
oral DHA supplementation at 2 grams per day
Group II: PlaceboPlacebo Group1 Intervention
Placebo for DHA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DHA
2009
Completed Phase 3
~3300

Find a Location

Who is running the clinical trial?

Huntington Medical Research InstitutesOTHER
5 Previous Clinical Trials
137 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
28,004,746 Total Patients Enrolled
Alzheimer's Drug Discovery FoundationOTHER
21 Previous Clinical Trials
2,773 Total Patients Enrolled

Media Library

DHA (Omega-3 Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT03613844 — Phase 2
Brain DHA Delivery and Alzheimer's Disease Risk Research Study Groups: Placebo, DHA
Brain DHA Delivery and Alzheimer's Disease Risk Clinical Trial 2023: DHA Highlights & Side Effects. Trial Name: NCT03613844 — Phase 2
DHA (Omega-3 Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03613844 — Phase 2

Frequently Asked Questions

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

What is the government agency's opinion of DHA?

"DHA scored a 2 in terms of safety. This is due to the fact that, while there have been Phase 2 trials conducted which support its safety, there are no studies which suggest it is an effective treatment."

Answered by AI

If I take part in this research, what are the benefits?

"The aim of this research is to enroll 368 patients that are currently experiencing alzheimer disease. These individuals must be between the ages of 55 and 80. To qualify, potential patients must also meet at least one of the following dementia risk factors: obesity, years spent in education, hypertension, or hyperlipidemia. Additionally, their MMSE score must be greater than 25 and their Logical Memory II delayed recall score must be between 6 and 18."

Answered by AI

If I am not yet 55 years old, can I still enroll in this research program?

"Eligibility for this study requires that potential patients are between 55 and 80 years old."

Answered by AI

Are people still able to sign up for this research project?

"This particular clinical trial is not presently looking for candidates, as per the information found on clinicaltrials.gov. The study was initially posted on 7/1/2018 and was last updated on 11/10/2022. There are 561 other trials recruiting patients at this time."

Answered by AI
~0 spots leftby May 2024