Omega 3 Oil: Aging-Related Cognitive Decline

July 20, 2022 updated by: Neurological Associates of West Los Angeles

ProdromeNeuro: A Phase I Study of Omega 3 Oil Nutritional Supplementation for Aging-Related Cognitive Decline

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (ALL participants)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ProdromeScan Blood Test
Time Frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 9-Hole Pegboard Task (9-HPT)
Time Frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
A validated assessment for fine motor skills, the 9-HPT involves having a participant move 9 pegs individually from starting position to 9 separate peg-holes, as quickly as possible, and to immediately return the 9 pegs to the starting position upon filling the final peg-hole. This is performed separately for each hand. The score is the time (seconds/milliseconds) that it takes to complete the task, recorded separately for dominant and non-dominant hands. The minimum detectable change is 2.6 seconds for the dominant hand and 1.3 seconds for the non-dominant hand.
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)
Time Frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status.
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)
Time Frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in a timed, 25-foot walk. Scoring for this task is the average number of steps (from first step to the first heel-strike after the finish line) and time taken (seconds/milliseconds) of two trials. Minimally clinically important difference (MCID) is 20% improvement in time taken and/or number of steps taken to complete.
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)
Time Frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in a timed, 25-foot walk. Scoring for this task is the average number of steps (from first step to the first heel-strike after the finish line) of two trials. Minimally clinically important difference (MCID) is 20% improvement in number of steps taken to complete.
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)
Time Frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
The 30-second chair stand involves recording the number of times that a person can complete a full stand in 30 seconds. This measure assesses functional lower extremity strength in older adults. The participant is instructed to complete as many full stands as possible within 30 seconds, starting in a seated position in the middle of an armless chair. The participant is instructed to fully sit between each stand. The tester silently counts the completion of each correct stand, and the score is the total number of stands within 30 seconds. The minimum clinically important difference (MCID) is 2 full stands per 30 second testing.
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 Quick Dementia Rating Scale (QDRS) used to calculate a Clinical Dementia Rating (CDR) scale
Time Frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia).
Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
Global Rating of Change (GRC)
Time Frame: Assessed at 6 month time point (reflecting on the study)
GThe GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.
Assessed at 6 month time point (reflecting on the study)
Change in Timed 25-foot Walk Test Speed (T25-FW)
Time Frame: Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)
The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in a timed, 25-foot walk. Scoring for this task is the average time to complete walk (in seconds/milliseconds) (from first step to the first heel-strike after the finish line) of two trials. Minimally clinically important difference (MCID) is 20% improvement in time taken to complete.
Change monitored from baseline to 6 month time point (also assessed for change at the end of each month is this time period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurological Associates of West Los Angeles

Collaborators

Prodrome Sciences Inc

Investigators

  • Study Director: Kennedy Mahdavi, BS, Neurological Associates
  • Principal Investigator: Sheldon Jordan, MD, Neurological Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 20, 2023

Primary Completion (Anticipated)

September 20, 2023

Study Completion (Anticipated)

November 20, 2023

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Plasmalogen2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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