Open-Label Study of Omega 3 Oil Supplementation for Aging-Related Cognitive Decline
ProdromeNeuro: An Open-Label Study of Omega 3 Oil Nutritional Supplementation for Aging-Related Cognitive Decline
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Santa Monica, California, United States, 90403
- Neurological Associates of West Los Angeles
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Omega 3 Oil Supplementation
Following all necessary screening, patients will be provided with the ProdromeNeuro Omega-3 oil supplement and instructed to consume the equivalent of 1 cc of the oil supplement per day for the first month, followed by 2 cc of the supplement/day for the second month, and finally ending with 4 cc/day of the supplement for the third month.
Neurocognitive assessment and serology testing will take place at baseline, end of month 1, end of month 2, end of month 3, and one month post intervention-termination.
|
ProdromeNeuro is an algae-derived Omega 3 oil nutritional supplement product comprised of naturally occurring alkylglycerol and natural fatty acids.
ProdromeNeuro functions as a natural plasmalogen precursor which can be administered orally.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick Dementia Rating Scale (QDRS)
Time Frame: Baseline
|
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).
|
Baseline
|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline
|
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.
|
Baseline
|
|
30 Second Sit-Stand (30CST)
Time Frame: Baseline
|
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.
|
Baseline
|
|
Timed 25-foot Walk Test (T25FW)
Time Frame: Baseline
|
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.
|
Baseline
|
|
9 Hole Pegboard Task (9 HPT)
Time Frame: Baseline
|
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.
|
Baseline
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
QDRS
Time Frame: End of Month 1
|
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).
|
End of Month 1
|
|
QDRS
Time Frame: End of Month 2
|
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).
|
End of Month 2
|
|
QDRS
Time Frame: End of Month 3
|
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).
|
End of Month 3
|
|
QDRS
Time Frame: End of Month 4
|
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).
|
End of Month 4
|
|
MoCA
Time Frame: End of Month 1
|
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.
|
End of Month 1
|
|
MoCA
Time Frame: End of Month 2
|
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.
|
End of Month 2
|
|
MoCA
Time Frame: End of Month 3
|
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.
|
End of Month 3
|
|
MoCA
Time Frame: End of Month 4
|
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.
|
End of Month 4
|
|
30CST
Time Frame: End of Month 1
|
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.
|
End of Month 1
|
|
30CST
Time Frame: End of Month 2
|
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.
|
End of Month 2
|
|
30CST
Time Frame: End of Month 3
|
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.
|
End of Month 3
|
|
30CST
Time Frame: End of Month 4
|
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.
|
End of Month 4
|
|
T25FW
Time Frame: End of Month 1
|
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.
|
End of Month 1
|
|
T25FW
Time Frame: End of Month 2
|
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.
|
End of Month 2
|
|
T25FW
Time Frame: End of Month 3
|
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.
|
End of Month 3
|
|
T25FW
Time Frame: End of Month 4
|
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.
|
End of Month 4
|
|
9HPT
Time Frame: End of Month 1
|
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.
|
End of Month 1
|
|
9HPT
Time Frame: End of Month 2
|
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.
|
End of Month 2
|
|
9HPT
Time Frame: End of Month 3
|
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.
|
End of Month 3
|
|
9HPT
Time Frame: End of Month 4
|
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.
|
End of Month 4
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
General Publications
- Lee A, Gilbert RM. Epidemiology of Parkinson Disease. Neurol Clin. 2016 Nov;34(4):955-965. doi: 10.1016/j.ncl.2016.06.012. Epub 2016 Aug 18.
- Trigiani LJ, Lacalle-Aurioles M, Bourourou M, Li L, Greenhalgh AD, Zarruk JG, David S, Fehlings MG, Hamel E. Benefits of physical exercise on cognition and glial white matter pathology in a mouse model of vascular cognitive impairment and dementia. Glia. 2020 Sep;68(9):1925-1940. doi: 10.1002/glia.23815. Epub 2020 Mar 10.
- Dietschy JM, Turley SD. Cholesterol metabolism in the brain. Curr Opin Lipidol. 2001 Apr;12(2):105-12. doi: 10.1097/00041433-200104000-00003.
- Mankidy R, Ahiahonu PW, Ma H, Jayasinghe D, Ritchie SA, Khan MA, Su-Myat KK, Wood PL, Goodenowe DB. Membrane plasmalogen composition and cellular cholesterol regulation: a structure activity study. Lipids Health Dis. 2010 Jun 14;9:62. doi: 10.1186/1476-511X-9-62.
- Braverman NE, Moser AB. Functions of plasmalogen lipids in health and disease. Biochim Biophys Acta. 2012 Sep;1822(9):1442-52. doi: 10.1016/j.bbadis.2012.05.008. Epub 2012 May 22.
- Muse ED, Jurevics H, Toews AD, Matsushima GK, Morell P. Parameters related to lipid metabolism as markers of myelination in mouse brain. J Neurochem. 2001 Jan;76(1):77-86. doi: 10.1046/j.1471-4159.2001.00015.x.
- Rouser G, Yamamoto A. Curvilinear regression course of human brain lipid composition changes with age. Lipids. 1968 May;3(3):284-7. doi: 10.1007/BF02531202. No abstract available.
- Engelmann B, Streich S, Schonthier UM, Richter WO, Duhm J. Changes of membrane phospholipid composition of human erythrocytes in hyperlipidemias. I. Increased phosphatidylcholine and reduced sphingomyelin in patients with elevated levels of triacylglycerol-rich lipoproteins. Biochim Biophys Acta. 1992 Nov 11;1165(1):32-7. doi: 10.1016/0005-2760(92)90072-4.
- Mandel H, Sharf R, Berant M, Wanders RJ, Vreken P, Aviram M. Plasmalogen phospholipids are involved in HDL-mediated cholesterol efflux: insights from investigations with plasmalogen-deficient cells. Biochem Biophys Res Commun. 1998 Sep 18;250(2):369-73. doi: 10.1006/bbrc.1998.9321.
- Poirier J, Miron J, Picard C, Gormley P, Theroux L, Breitner J, Dea D. Apolipoprotein E and lipid homeostasis in the etiology and treatment of sporadic Alzheimer's disease. Neurobiol Aging. 2014 Sep;35 Suppl 2(Suppl 2):S3-10. doi: 10.1016/j.neurobiolaging.2014.03.037. Epub 2014 May 15.
- Leoni V, Solomon A, Kivipelto M. Links between ApoE, brain cholesterol metabolism, tau and amyloid beta-peptide in patients with cognitive impairment. Biochem Soc Trans. 2010 Aug;38(4):1021-5. doi: 10.1042/BST0381021.
- Michikawa M, Fan QW, Isobe I, Yanagisawa K. Apolipoprotein E exhibits isoform-specific promotion of lipid efflux from astrocytes and neurons in culture. J Neurochem. 2000 Mar;74(3):1008-16. doi: 10.1046/j.1471-4159.2000.0741008.x.
- Su XQ, Wang J, Sinclair AJ. Plasmalogens and Alzheimer's disease: a review. Lipids Health Dis. 2019 Apr 16;18(1):100. doi: 10.1186/s12944-019-1044-1.
- Farooqui AA, Horrocks LA, Farooqui T. Glycerophospholipids in brain: their metabolism, incorporation into membranes, functions, and involvement in neurological disorders. Chem Phys Lipids. 2000 Jun;106(1):1-29. doi: 10.1016/s0009-3084(00)00128-6.
- Zoeller RA, Lake AC, Nagan N, Gaposchkin DP, Legner MA, Lieberthal W. Plasmalogens as endogenous antioxidants: somatic cell mutants reveal the importance of the vinyl ether. Biochem J. 1999 Mar 15;338 ( Pt 3)(Pt 3):769-76.
- Broniec A, Klosinski R, Pawlak A, Wrona-Krol M, Thompson D, Sarna T. Interactions of plasmalogens and their diacyl analogs with singlet oxygen in selected model systems. Free Radic Biol Med. 2011 Apr 1;50(7):892-8. doi: 10.1016/j.freeradbiomed.2011.01.002. Epub 2011 Jan 12.
- Sindelar PJ, Guan Z, Dallner G, Ernster L. The protective role of plasmalogens in iron-induced lipid peroxidation. Free Radic Biol Med. 1999 Feb;26(3-4):318-24. doi: 10.1016/s0891-5849(98)00221-4.
- Stables MJ, Gilroy DW. Old and new generation lipid mediators in acute inflammation and resolution. Prog Lipid Res. 2011 Jan;50(1):35-51. doi: 10.1016/j.plipres.2010.07.005. Epub 2010 Jul 23.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- ProdromeNeuro
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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