Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Description

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.

Conditions

Eldery People, Cognitive Decline, Memory Decline, DHA CNS Delivery

Study Overview

Study Details

Study 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. 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.

Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Condition
Eldery People
Intervention / Treatment

-

Contacts and Locations

Cincinnati

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio, United States, 45219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

62 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Cincinnati,

Robert McNamara, PhD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Study Record Dates

2029-09-15