Clinical trial NCT04484454: Open-Label Study of Omega 3 Oil Supplementation for Aging-Related Cognitive Decline
Official title: ProdromeNeuro: An Open-Label Study of Omega 3 Oil Nutritional Supplementation for Aging-Related Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Keywords: Aging
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
Collaborators: name: Prodrome Sciences
First posted: 2020-07-23
Enrollment: 20
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aging-related cognitive decline may be affected by brain cholesterol and the health of cell membranes. Certain nutritional supplements have been proposed to support membrane health, and there is increasing interest in plasmalogens and Omega-3 derived oil supplements to support brain health among older adults. The product being investigated in this study is the ProdromeNeuro Omega 3 oil nutritional supplement. This product contains naturally occurring fatty acids in higher concentrations than similar products that are commercially available. The purpose of this research study is to better understand the effects of ProdromeNeuro Omega-3 nutritional supplementation among subjects with age-related cognitive decline.

Detailed description: There has been an increasing interest in plasmalogens as a potential therapeutic agent for age-related cognitive decline and neurodegenerative conditions, given the growing understanding of their involvement in key cellular functions as well as the clinical trends observed when plasmalogen levels are depleted. In addition to supporting the structural integrity of membranes, these plasmalogens are also involved in a variety of critically important cell functions: membrane fusion, ion transport, vesicle formation, and oxidation-reduction. Plasmalogen and serum plasmalogen deficiency has been shown to impair cellular functions, particularly related to cholesterol processing, and has been implicated in Alzheimer's and other diseases. Plasmalogen precursor supplementation has been demonstrated as safe and potentially efficacious in preclinical studies and some patient populations. In theory, ProdromeNeuro supplementation may yield therapeutic benefits among patients with age-related cognitive decline by increasing levels of neuroprotective plasmalogens.

The present study is being undertaken as an open-label study to evaluate the safety and tolerability of ProdromeNeuro Omega-3 Oil as an intervention for patients with age-related cognitive decline. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures. Neurocognitive assessment and serology testing kits to evaluate for plasmalogen levels will also be administered at baseline, end of the first month, end of the second month, end of the 3 month, and after one month post treatment termination.

Eligibility criteria: Inclusion Criteria:

* Cognitive decline due to aging-related changes
* Clinical Dementia Rating stage of mild dementia 0.5 through moderate dementia CDR stages 1 and 2

Exclusion Criteria:

* Subjects unable to give informed consent
* Cognitive decline clearly related to an acute illness
* Subjects taking anticoagulants and anti-platelet agents
* Advanced terminal illness
* Any active cancer or chemotherapy
* Any other neoplastic illness or illness characterized by neovascularity

Primary outcomes:
measure: Quick Dementia Rating Scale (QDRS)
timeFrame: Baseline
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline
measure: 30 Second Sit-Stand (30CST)
timeFrame: Baseline
measure: Timed 25-foot Walk Test (T25FW)
timeFrame: Baseline
measure: 9 Hole Pegboard Task (9 HPT)
timeFrame: Baseline
Secondary outcomes:
measure: QDRS
timeFrame: End of Month 1
measure: QDRS
timeFrame: End of Month 2
measure: QDRS
timeFrame: End of Month 3
measure: QDRS
timeFrame: End of Month 4
measure: MoCA
timeFrame: End of Month 1
measure: MoCA
timeFrame: End of Month 2
measure: MoCA
timeFrame: End of Month 3
measure: MoCA
timeFrame: End of Month 4
measure: 30CST
timeFrame: End of Month 1
measure: 30CST
timeFrame: End of Month 2
measure: 30CST
timeFrame: End of Month 3
measure: 30CST
timeFrame: End of Month 4
measure: T25FW
timeFrame: End of Month 1
measure: T25FW
timeFrame: End of Month 2
measure: T25FW
timeFrame: End of Month 3
measure: T25FW
timeFrame: End of Month 4
measure: 9HPT
timeFrame: End of Month 1
measure: 9HPT
timeFrame: End of Month 2
measure: 9HPT
timeFrame: End of Month 3
measure: 9HPT
timeFrame: End of Month 4
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West Los Angeles
state: California
Study officials:
affiliation: Neurological Associates of West Los Angeles
name: Sheldon Jordan, MD
role: PRINCIPAL_INVESTIGATOR
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