Clinical trial NCT05041088: Omega 3 Oil: Aging-Related Cognitive Decline
Official title: ProdromeNeuro: A Phase I Study of Omega 3 Oil Nutritional Supplementation for Aging-Related Cognitive Decline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Aging Related Cognitive Decline
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
Collaborators: name: Prodrome Sciences Inc
First posted: 2021-09-10
Enrollment: 40
Sex: ALL
Standard ages: CHILD
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. Plasmalogens are compounds found in neural cell membranes that are connected to cholesterol processing. Neural cells that have low plasmalogens have shown an inability to process cholesterol properly. Recent research suggests that abnormalities in cholesterol processing and low levels of plasmalogen may play a role in age-related cognitive decline.

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 participants with age-related cognitive decline. It is hoped that taking this product over the course of 4 months will result in improved plasmalogen levels, brain connectivity seen on advanced brain imaging, as well as improved cognitive assessment measurements.


Eligibility criteria: Inclusion Criteria:

* Evidence of a degenerative process
* Clinical Dementia Rating (CDR) score indicating mild cognitive impairment (CDR = 0.5), mild dementia (CDR = 1) through moderate dementia (CDR = 2)

Exclusion Criteria:

* Subjects unable to give informed assent
* Cognitive decline clearly related to an acute illness
* Advanced terminal illness
* Any active cancer or chemotherapy
* Any other neoplastic illness or illness characterized by neovascularity or angiopathy
* Subjects previously taking plasmalogen supplementation prior to study enrollment

Primary outcomes:
measure: Change in ProdromeScan Blood Test
timeFrame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Secondary outcomes:
measure: Change in 9-Hole Pegboard Task (9-HPT)
timeFrame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
measure: Change in Montreal Cognitive Assessment (MoCA)
timeFrame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
measure: Change in Timed 25-foot Walk Test (T25-FW)
timeFrame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
measure: Change in Timed 25-foot Walk Test Steps (T25-FW)
timeFrame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
measure: Change in 30-Second Sit Stand (30CST)
timeFrame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
measure: Change in Quick Dementia Rating Scale (QDRS) used to calculate a Clinical Dementia Rating (CDR) scale
timeFrame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
measure: Global Rating of Change (GRC)
timeFrame: Assessed at 6 month time point (reflecting on the study)
measure: Change in Timed 25-foot Walk Test Speed (T25-FW)
timeFrame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Other outcomes:
Locations:
Study officials:
affiliation: Neurological Associates
name: Kennedy Mahdavi, BS
role: STUDY_DIRECTOR
affiliation: Neurological Associates
name: Sheldon Jordan, MD
role: PRINCIPAL_INVESTIGATOR
References: