Eldery PeopleNCT06933095
Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
A study testing LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) in people with Eldery People and Cognitive Decline, run by University of Cincinnati at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 to 82 years
- Conditions the study is for
- Eldery People, Cognitive Decline, Memory Decline
- What is being tested?
- LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2024to 15 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women 55 to 82 years old;
- presence of subjective cognitive decline or mild cognitive decline using the SCD questionnaire, DEX, EMQ, MoCA; and mCDR;
- No contraindication to a lumbar puncture (LP) unless opting to not have the LP (e.g., thrombocytopenia, coagulopathy, concomitant use of anticoagulant medications, etc.);
- fluency in English;
- ability to comprehend and comply with the research protocol; and
- provision of written informed consent.
Who cannot join
- diagnosis of dementia due to AD, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, head trauma with loss of consciousness lasting more than 5 minutes and resulting in persisting functional decline within the three years prior to enrollment, epilepsy, leukoencephalopathy, other neurological conditions that would interfere the study objectives, mMIST <8 or MoCA-MI score <7;
- self-reported history of any psychotic disorder or bipolar disorder;
- diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder;
- allergy to shellfish or seafood;
- current substance use causing physiological dependence or persisting change in functional capability;
- concomitant, regular use of medications that might affect primary outcome measures or adversely interact with the study product including anticoagulant medications;
- weekly fish consumption more than 1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, 45219
Karen Tugrul, 513-558-6831, tugrulkc@ucmail.uc.edu
Dawn Skirpan, 513-558-8621, skirpadn@ucmail.uc.edu
About this study
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 including those with mild cognitive impairment (MCI). 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.
Read more
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.
- Conditions
- Eldery People, Cognitive Decline, Memory Decline, DHA CNS Delivery
- Being tested
- LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)Dietary supplement
apsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)
| Study group | Role | What they receive |
|---|---|---|
| Placebo (mixture of olive oil, corn oil, palm oil) | Placebo comparator | Placebo Receives: Dietary Supplement: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) |
| fish oil | Active comparator | Fish Oil Receives: Dietary Supplement: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) |
| LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified t | Experimental | LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) Receives: Dietary Supplement: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF Docosahexaenoic acid (DHA) levels
Baseline-Endpoint change in CSF docosahexaenoic acid (DHA) composition (g/100 g).
Measured: From baseline through week 24
Secondary outcomes (7)
Amyloid-β1-42 (Aβ42)
Baseline-Endpoint change in blood and CSF amyloid-β1-42 concentrations (ng/ml)
Measured: Baseline through week 24
Phospho-tau217 (p-tau217)
Baseline-Endpoint change in blood and CSF p-tau217 concentrations (ng/ml)
Measured: Baseline and Week 24
Brain-derived neurotrophic factor (BDNF)
Baseline-Endpoint change in blood and CSF BDNF concentrations (ng/ml)
Measured: Baseline and Week 24
Genotyping
APOE alleles (ε2, ε3, ε4) allele frequency
Measured: Baseline
California Verbal Learning Test
Objective assessment of episodic memory performance (Units on a scale) Scores range from 0 to 16 for individual learning trials, 0 to 80 for total words recalled across all trials, 0 to 16 for both short and long-delay free recall, and 0 to 16 for total hits. Higher scores indicate better performance on verbal memory
Measured: Baseline, Week 12, Week 24
Trail-Making Test, part B
Objective measure of speed of processing/executive functioning (Units on a scale). Scores range from 0 to 300 seconds to complete the task. Lower scores indicate better performance on executive function.
Measured: Baseline, week 12, and week 24
Geriatric Depression Scale
Assessment of depression symptom severity (Units on a scale). The score range is from 0 to 15, with higher scores indicating more severe depression.
Measured: Screening, Baseline, week 12, and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start15 Sep 2024
- Primary completion15 Sep 2029 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eldery PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert McNamara, University of Cincinnati
- Investigators
- Robert McNamara, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933095
- Sponsor's protocol ID
- CNS DHA Delivery
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
- ClinicalTrials.gov ID
- NCT06933095
- Acronym / sponsor ID
- CNS DHA Delivery
- Conditions
- Eldery People, Cognitive Decline, Memory Decline, DHA CNS Delivery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Sep 2029 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 including those with mild cognitive impairment (MCI). 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (mixture of olive oil, corn oil, palm oil) | Placebo comparator | Dietary Supplement: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)Placebo |
| fish oil | Active comparator | Dietary Supplement: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)Fish Oil |
| LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified t | Experimental | Dietary Supplement: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) |
Who may qualify
- Ages
- 55 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- men and women 55 to 82 years old;
- presence of subjective cognitive decline or mild cognitive decline using the SCD questionnaire, DEX, EMQ, MoCA; and mCDR;
- No contraindication to a lumbar puncture (LP) unless opting to not have the LP (e.g., thrombocytopenia, coagulopathy, concomitant use of anticoagulant medications, etc.);
- fluency in English;
- ability to comprehend and comply with the research protocol; and
Key exclusion criteria (7 listed)
- diagnosis of dementia due to AD, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, head trauma with loss of consciousness lasting more than 5 minutes and resulting in persisting functional decline within the three years prior to enrollment, epilepsy, leukoencephalopathy, other neurological conditions that would interfere the study objectives, mMIST <8 or MoCA-MI score <7;
- self-reported history of any psychotic disorder or bipolar disorder;
- diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder;
- allergy to shellfish or seafood;
- current substance use causing physiological dependence or persisting change in functional capability;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)apsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) | Dietary supplement | LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified t, Placebo (mixture of olive oil, corn oil, palm oil), fish oil |
Primary outcome
CSF Docosahexaenoic acid (DHA) levels
Time frame: From baseline through week 24
Baseline-Endpoint change in CSF docosahexaenoic acid (DHA) composition (g/100 g).
7 secondary outcomes
Amyloid-β1-42 (Aβ42)
Time frame: Baseline through week 24
Phospho-tau217 (p-tau217)
Time frame: Baseline and Week 24
Brain-derived neurotrophic factor (BDNF)
Time frame: Baseline and Week 24
Genotyping
Time frame: Baseline
California Verbal Learning Test
Time frame: Baseline, Week 12, Week 24
Trail-Making Test, part B
Time frame: Baseline, week 12, and week 24
Geriatric Depression Scale
Time frame: Screening, Baseline, week 12, and week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert McNamara, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) in people with Eldery People and Cognitive Decline, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert McNamara, PhD (513-558-6831, mcnamar@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF Docosahexaenoic acid (DHA) levels (time frame: From baseline through week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.