Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

University of Cincinnati

Status: Active, not recruiting

Conditions: DHA CNS Delivery; Cognitive Decline; Memory Decline; Eldery People

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06933095

CNS DHA Delivery

Details and patient eligibility

About

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.

Enrollment: 153 estimated patients

Sex: All

Ages: 62 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. men and women 62 to 80 years old;
2. presence of subjective cognitive decline using the SCD questionnaire, DEX and EMQ, education-adjusted MoCA score of >23 [106,107]; CVLT cumulative acquisition score >1.5 SD below the age-adjusted mean, and preservation of independence in functional abilities, as corroborated by an informant providing information on the mCDR [108];
3. No contraindication to a lumbar puncture (e.g., thrombocytopenia, coagulopathy, concomitant use of anticoagulant medications, etc.);
4. fluency in English;
5. ability to comprehend and comply with the research protocol; and
6. provision of written informed consent.

Exclusion criteria

1. diagnosis of MCI, AD, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, significant head trauma, epilepsy, leukoencephalopathy, or other neurological condition;
2. self-reported emotional disorder such as severe depression or other psychiatric condition causing a persisting decline in functional capability;
3. diagnosis of diabetes, pancreatic, liver, kidney or hematological coagulation disorder;
4. allergy to shellfish or seafood;
5. current or past substance use causing physiological dependence or persisting change in functional capability;
6. concomitant, regular use of medications that might affect outcome measures or adversely interact with the study product including anticoagulant medications;
7. weekly fish consumption >1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

153 participants in 3 patient groups, including a placebo group

Placebo (mixture of olive oil, corn oil, palm oil)

Placebo Comparator group

Description:

Placebo

Treatment:

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 group

Description:

Fish Oil

Treatment:

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 group

Description:

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

Treatment:

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