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

Trial Summary

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.

What data supports the effectiveness of the treatment LPC-EPA+DHA for dementia?

Research suggests that omega-3 fatty acids, like EPA and DHA, may help reduce the risk of dementia and cognitive decline. Long-term use of these supplements has been linked to a lower risk of Alzheimer's disease, and higher intake of DHA and EPA is associated with a reduced risk of cognitive decline. ^{1 2 3 4 5}

Is it safe to take omega-3 fatty acids for dementia?

Omega-3 fatty acids, often found in fish oil, are generally considered safe for humans, with studies showing a low frequency of side effects similar to those of a placebo. While their effectiveness in treating dementia is unclear, they are not associated with significant safety concerns. ^{1 2 3 6 7}

How does the treatment LPC-EPA+DHA differ from other treatments for dementia?

LPC-EPA+DHA is unique because it combines specific omega-3 fatty acids, EPA and DHA, which have shown potential benefits in reducing inflammation and protecting brain cells, possibly lowering the risk of dementia. Unlike some other treatments, this approach focuses on dietary supplementation to improve cognitive health, especially in individuals with mild memory issues. ^{1 2 3 8 9}

What is the purpose of this trial?

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 DHA levels, as well as biomarkers of central neurodegenerative and neurotrophic activity, in elderly adults experiencing early signs of cognitive/memory decline. Extant evidence supports our overarching hypothesis that LPC-DHA supplementation will be more effective than TAG-DHA for increasing central (CSF) DHA levels and improving biomarker profiles in elderly adults. To assess this hypothesis, the following aims are proposed: SPECIFIC AIM 1: To compare the effects of LPC-DHA and TAG-DHA supplementation on peripheral and CSF DHA levels in elderly adults experiencing early signs of cognitive/memory decline. SPECIFIC AIM 2: To compare the effects of LPC-DHA and TAG-DHA supplementation on neurotrophic and neurodegenerative biomarkers. Secondary Aim: To investigate whether changes in CSF DHA levels correlate with changes in objective measures of executive functioning and episodic memory performance.

Research Team

Robert McNamara, PhD

Principal Investigator

University of Cincinnati

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Blood polyunsaturated omega-3 fatty acids, brain atrophy, cognitive decline, and dementia risk. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Fish, n-3 fatty acids, cognition and dementia risk: not just a fishy tale. [2022]

3. United States 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. [2023]

4. France pubmed.ncbi.nlm.nih.gov

High dietary and plasma levels of the omega-3 fatty acid docosahexaenoic acid are associated with decreased dementia risk: the Rancho Bernardo study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Fish intake, n-3 fatty acid body status, and risk of cognitive decline: a systematic review and a dose-response meta-analysis of observational and experimental studies. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Fish consumption, long-chain omega-3 fatty acids and risk of cognitive decline or Alzheimer disease: a complex association. [2022]

7. Portugal pubmed.ncbi.nlm.nih.gov

[Analysis of the Cochrane Review: Omega-3 Fatty Acids for the Treatment of Dementia. Cochrane Database Syst Rev. 2016;4:CD009002.] [2018]

8. Canada pubmed.ncbi.nlm.nih.gov

Effects of N-3 Polyunsaturated Fatty Acids on Dementia. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Circulating polyunsaturated fatty acids, fish oil supplementation, and risk of incident dementia: a prospective cohort study of 440,750 participants. [2023]