Omega 3 Oil: Aging-Related Cognitive Decline

Study Overview
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Brief Summary
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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.

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

Conditions
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Aging Related Cognitive Decline

Intervention / Treatment
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* Dietary Supplement: ProdromeNeuro Plasmalogen


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group (ALL participants)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 9-Hole Pegboard Task (9-HPT) | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) |