Omega 3 Oil: Aging-Related Cognitive Decline

NCT05041088 | Unknown Phase 1

• 1 other identifier: Plasmalogen2.0
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aging Related Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• Change in ProdromeScan Blood Test

  serological testing kit for plasmalogen levels

  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 (8)

• Change in 9-Hole Pegboard Task (9-HPT)

  Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)

• Change in Montreal Cognitive Assessment (MoCA)

  Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)

• Change in Timed 25-foot Walk Test (T25-FW)

  Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)

• Change in Timed 25-foot Walk Test Steps (T25-FW)

  Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)

• Change in 30-Second Sit Stand (30CST)

  Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)

Study Arms (1)

Experimental Group (ALL participants)

EXPERIMENTAL

This group will be taking plamalogen supplement (ProdromeNeuro) and be followed through the study with neuropsychological testing, serology, and follow up MRI data. They will be administered 2mL per day for 6 months

Dietary Supplement: ProdromeNeuro Plasmalogen

Interventions

ProdromeNeuro Plasmalogen DIETARY_SUPPLEMENT

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.

Experimental Group (ALL participants)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead
• Prodrome Sciences Inc: collaborator

Study Officials

• Kennedy Mahdavi, BS

  Neurological Associates

  STUDY DIRECTOR

• Sheldon Jordan, MD

  Neurological Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maggie Zielinski, BS

CONTACT

3108295968; mzielinski@theneuroassociates.com

Jonathan Haroon, BS

CONTACT

3108295968; jharoon@theneuroassociates.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 10, 2021
• Study Start: June 20, 2023
• Primary Completion: September 20, 2023
• Study Completion: November 20, 2023
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share