Omega-3 Fatty Acids for Dementia

Overseen By Robert Krikorian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Must not be taking: Anticoagulants

Disqualifiers: MCI, AD, Parkinson's, Diabetes, others

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

153 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of different omega-3 supplements in enhancing brain function in older adults with early memory problems. Researchers are comparing two types of omega-3s, LPC-DHA and TAG-DHA, to determine which better boosts important brain chemicals and improves memory and thinking skills. The study includes a placebo, a harmless pill with no active ingredients, to measure real effects. Older adults who notice memory decline but still manage daily tasks well might be suitable for this trial, especially if they do not consume much fish or regularly take omega-3 supplements. As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of omega-3s on brain health.

Will I have to stop taking my current medications?

The trial requires that you do not regularly use medications that might affect the study's outcome or interact with the study product, including anticoagulant medications. If you are taking such medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LPC-EPA+DHA supplements are as safe as other common omega-3 supplements, allowing most people to take them without issues. Studies have found that these supplements can increase DHA levels in the brain, which is crucial for brain health. Animal studies suggest they may also aid memory and behavior. Overall, evidence indicates that LPC-EPA+DHA is safe for humans, with no major side effects reported in studies so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for dementia, such as cholinesterase inhibitors and memantine, which primarily aim to manage symptoms, LPC-EPA+DHA introduces a novel approach by using omega-3 fatty acids esterified to lysophosphatidylcholine (LPC). This unique formulation is designed to improve the delivery of EPA and DHA, essential fatty acids believed to have neuroprotective effects. Researchers are excited because this method could enhance brain uptake of these fatty acids, potentially offering a new way to support brain health and slow cognitive decline in dementia patients.

What evidence suggests that this trial's treatments could be effective for dementia?

Studies have shown that higher levels of DHA, a type of omega-3 fatty acid, in the blood link to better thinking skills and a lower risk of dementia. Research suggests that LPC-DHA/EPA, a form of omega-3s, can increase DHA levels in the brain and improve memory in animal studies. Additionally, diets rich in LPC-DHA/EPA significantly reduced harmful eye protein levels in Alzheimer's disease models. These findings suggest that LPC-EPA+DHA, which participants in this trial may receive, might improve brain health and memory in people with early signs of cognitive decline. Early evidence supports the idea that LPC-EPA+DHA could be more effective than other omega-3 forms, like TAG-DHA, in achieving these benefits. ^{1 2 4 6 7}

Who Is on the Research Team?

Robert McNamara, PhD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for elderly adults showing early signs of cognitive or memory decline, potentially at risk for dementia. Participants should be experiencing mild cognitive impairment or have had a stroke that could lead to dementia.

Inclusion Criteria

Fluency in English

Provision of written informed consent

Presence of subjective cognitive decline using the SCD questionnaire, DEX and EMQ

Exclusion Criteria

Allergy to shellfish or seafood

Current or past substance use causing physiological dependence or persisting change in functional capability

I have been diagnosed with a specific neurological condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 24 weeks of supplementation with LPC-DHA or TAG-DHA to assess effects on DHA levels and biomarkers

24 weeks

3 visits (in-person) at baseline, week 12, and week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LPC-EPA+DHA

Trial Overview

The study tests the effectiveness of two types of omega-3 fatty acid supplements: LPC-EPA+DHA (Lysoveta) versus TAG-DHA. Over 24 weeks, their impact on brain and blood DHA levels and biomarkers related to neurodegeneration will be compared.

How Is the Trial Designed?

Group I: LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified t Experimental Treatment 1 Intervention

LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)

Group II: fish oil Active Control 1 Intervention

Fish Oil

Group III: Placebo (mixture of olive oil, corn oil, palm oil) Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Published Research Related to This Trial

Long-term use of omega-3 fatty acid supplements was associated with a 64% reduced risk of developing Alzheimer's disease in a study of 1,135 participants over 6 years.

A meta-analysis of 48 studies involving over 103,000 participants indicated that dietary intake of omega-3 fatty acids could lower the risk of all-cause dementia or cognitive decline by approximately 20%, particularly highlighting the benefits of docosahexaenoic acid (DHA).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship of Omega-3 Fatty Acids with Dementia and Cognitive Decline: Evidence from Prospective Cohort Studies of Supplementation, Dietary Intake, and Blood Markers. Wei, BZ., Li, L., Dong, CW., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06933095

Optimizing CNS DHA Delivery in Elderly Adults at Risk for ...

The purpose of this placebo-controlled trial is to compare the effects of 24-weeks supplementation with LPC-DHA and TAG-DHA on cerebrospinal fluid and blood ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0952327824000553

Providing lysophosphatidylcholine-bound omega-3 fatty ...

Epidemiological studies have shown that increased blood DHA levels are associated with higher cognitive scores and a lower risk for developing dementia, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8282213/

LPC-DHA/EPA-Enriched Diets Increase Brain ...

In conclusion, our data demonstrate that LPC-DHA/EPA-enriched krill oil can increase brain DHA and improve memory-relevant behavior in mice that ...

4.

pharmacytimes.com

pharmacytimes.com/view/ongoing-clinical-trial-compares-omega-3-types-for-dementia-risk-reduction

Ongoing Clinical Trial Compares Omega-3 Types for ...

Omega-3 fatty acids could aid early dementia symptoms and decrease the risk of Alzheimer disease, offering a cost-effective and well-tolerated treatment option ...

5.

nature.com

nature.com/articles/s41598-023-36268-0

Improvement of retinal function in Alzheimer disease ...

Retinal amyloid β levels were decreased by about 50% by the LPC-DHA/EPA diet, and by about 17% with the TAG-DHA/EPA diet. These results show ...

6.

alzdiscovery.org

alzdiscovery.org/uploads/cognitive_vitality_media/Lysophosphatidylcholine-Omega3_(supplement).pdf

Lysophosphatidylcholine-Omega3

Safety: LPC-DHA/EPA supplements are expected to have a safety profile similar to currently available phospholipid, triglyceride, and ethyl ester-bound DHA/EPA ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6399499/

Dietary lysophosphatidylcholine-EPA enriches both ...

Because LPC-EPA increased both EPA and DHA in the brain, it may help in the treatment of depression as well as neuroinflammatory diseases, such as Alzheimer's ...