Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta).
- Who it may be relevant to
- Registry conditions: Eldery People, Cognitive Decline, Memory Decline, DHA CNS Delivery. Basic parameters: 55 years — 82 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement 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)
Primary outcome measures
- CSF Docosahexaenoic acid (DHA) levels [Time frame: From baseline through week 24]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience — Cincinnati
Identifiers
NCT: NCT06933095 · CNS DHA Delivery