<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04484454</url>
  </required_header>
  <id_info>
    <org_study_id>ProdromeNeuro</org_study_id>
    <nct_id>NCT04484454</nct_id>
  </id_info>
  <brief_title>Open-Label Study of Omega 3 Oil Supplementation for Aging-Related Cognitive Decline</brief_title>
  <official_title>ProdromeNeuro: An Open-Label Study of Omega 3 Oil Nutritional Supplementation for Aging-Related Cognitive Decline</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurological Associates of West Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prodrome Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Neurological Associates of West Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aging-related cognitive decline may be affected by brain cholesterol and the health of cell&#xD;
      membranes. Certain nutritional supplements have been proposed to support membrane health, and&#xD;
      there is increasing interest in plasmalogens and Omega-3 derived oil supplements to support&#xD;
      brain health among older adults. The product being investigated in this study is the&#xD;
      ProdromeNeuro Omega 3 oil nutritional supplement. This product contains naturally occurring&#xD;
      fatty acids in higher concentrations than similar products that are commercially available.&#xD;
      The purpose of this research study is to better understand the effects of ProdromeNeuro&#xD;
      Omega-3 nutritional supplementation among subjects with age-related cognitive decline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There has been an increasing interest in plasmalogens as a potential therapeutic agent for&#xD;
      age-related cognitive decline and neurodegenerative conditions, given the growing&#xD;
      understanding of their involvement in key cellular functions as well as the clinical trends&#xD;
      observed when plasmalogen levels are depleted. In addition to supporting the structural&#xD;
      integrity of membranes, these plasmalogens are also involved in a variety of critically&#xD;
      important cell functions: membrane fusion, ion transport, vesicle formation, and&#xD;
      oxidation-reduction. Plasmalogen and serum plasmalogen deficiency has been shown to impair&#xD;
      cellular functions, particularly related to cholesterol processing, and has been implicated&#xD;
      in Alzheimer's and other diseases. Plasmalogen precursor supplementation has been&#xD;
      demonstrated as safe and potentially efficacious in preclinical studies and some patient&#xD;
      populations. In theory, ProdromeNeuro supplementation may yield therapeutic benefits among&#xD;
      patients with age-related cognitive decline by increasing levels of neuroprotective&#xD;
      plasmalogens.&#xD;
&#xD;
      The present study is being undertaken as an open-label study to evaluate the safety and&#xD;
      tolerability of ProdromeNeuro Omega-3 Oil as an intervention for patients with age-related&#xD;
      cognitive decline. Baseline and outcome measures in this study utilize validated tests that&#xD;
      are appropriate for repeated measures. Neurocognitive assessment and serology testing kits to&#xD;
      evaluate for plasmalogen levels will also be administered at baseline, end of the first&#xD;
      month, end of the second month, end of the 3 month, and after one month post treatment&#xD;
      termination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Actual">March 13, 2021</completion_date>
  <primary_completion_date type="Actual">March 13, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quick Dementia Rating Scale (QDRS)</measure>
    <time_frame>Baseline</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30 Second Sit-Stand (30CST)</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed 25-foot Walk Test (T25FW)</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9 Hole Pegboard Task (9 HPT)</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QDRS</measure>
    <time_frame>End of Month 1</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QDRS</measure>
    <time_frame>End of Month 2</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QDRS</measure>
    <time_frame>End of Month 3</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QDRS</measure>
    <time_frame>End of Month 4</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MoCA</measure>
    <time_frame>End of Month 1</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MoCA</measure>
    <time_frame>End of Month 2</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MoCA</measure>
    <time_frame>End of Month 3</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MoCA</measure>
    <time_frame>End of Month 4</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30CST</measure>
    <time_frame>End of Month 1</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30CST</measure>
    <time_frame>End of Month 2</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30CST</measure>
    <time_frame>End of Month 3</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30CST</measure>
    <time_frame>End of Month 4</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T25FW</measure>
    <time_frame>End of Month 1</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T25FW</measure>
    <time_frame>End of Month 2</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T25FW</measure>
    <time_frame>End of Month 3</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T25FW</measure>
    <time_frame>End of Month 4</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>9HPT</measure>
    <time_frame>End of Month 1</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>9HPT</measure>
    <time_frame>End of Month 2</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>9HPT</measure>
    <time_frame>End of Month 3</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>9HPT</measure>
    <time_frame>End of Month 4</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Omega 3 Oil Supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ProdromeNeuro Omega 3 Oil Nutritional Supplement</intervention_name>
    <description>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.</description>
    <arm_group_label>Omega 3 Oil Supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cognitive decline due to aging-related changes&#xD;
&#xD;
          -  Clinical Dementia Rating stage of mild dementia 0.5 through moderate dementia CDR&#xD;
             stages 1 and 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects unable to give informed consent&#xD;
&#xD;
          -  Cognitive decline clearly related to an acute illness&#xD;
&#xD;
          -  Subjects taking anticoagulants and anti-platelet agents&#xD;
&#xD;
          -  Advanced terminal illness&#xD;
&#xD;
          -  Any active cancer or chemotherapy&#xD;
&#xD;
          -  Any other neoplastic illness or illness characterized by neovascularity&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheldon Jordan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neurological Associates of West Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neurological Associates of West Los Angeles</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>27720003</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>32154952</PMID>
  </reference>
  <reference>
    <citation>Dietschy JM, Turley SD. Cholesterol metabolism in the brain. Curr Opin Lipidol. 2001 Apr;12(2):105-12. doi: 10.1097/00041433-200104000-00003.</citation>
    <PMID>11264981</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20546600</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22627108</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11145980</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17805871</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1420345</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9753636</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24973118</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20658997</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10693931</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30992016</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10878232</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10051451</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21236336</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9895222</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20655950</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>June 3, 2021</last_update_submitted>
  <last_update_submitted_qc>June 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484454
org study id: ProdromeNeuro
nct id: NCT04484454
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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. 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 subjects with age-related cognitive decline.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quick Dementia Rating Scale (QDRS)
time frame: Baseline
description: 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).
measure: Montreal Cognitive Assessment (MoCA)
time frame: Baseline
description: 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.
measure: 30 Second Sit-Stand (30CST)
time frame: Baseline
description: 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.
measure: Timed 25-foot Walk Test (T25FW)
time frame: Baseline
description: 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.
measure: 9 Hole Pegboard Task (9 HPT)
time frame: Baseline
description: 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.
measure: QDRS
time frame: End of Month 1
description: 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).
measure: QDRS
time frame: End of Month 2
description: 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).
measure: QDRS
time frame: End of Month 3
description: 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).
measure: QDRS
time frame: End of Month 4
description: 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).
measure: MoCA
time frame: End of Month 1
description: 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.
measure: MoCA
time frame: End of Month 2
description: 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.
measure: MoCA
time frame: End of Month 3
description: 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.
measure: MoCA
time frame: End of Month 4
description: 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.
measure: 30CST
time frame: End of Month 1
description: 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.
measure: 30CST
time frame: End of Month 2
description: 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.
measure: 30CST
time frame: End of Month 3
description: 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.
measure: 30CST
time frame: End of Month 4
description: 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.
measure: T25FW
time frame: End of Month 1
description: 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.
measure: T25FW
time frame: End of Month 2
description: 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.
measure: T25FW
time frame: End of Month 3
description: 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.
measure: T25FW
time frame: End of Month 4
description: 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.
measure: 9HPT
time frame: End of Month 1
description: 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.
measure: 9HPT
time frame: End of Month 2
description: 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.
measure: 9HPT
time frame: End of Month 3
description: 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.
measure: 9HPT
time frame: End of Month 4
description: 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.
arm group label: Omega 3 Oil Supplementation
arm group type: Experimental
description: 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.
intervention type: Dietary Supplement
intervention name: ProdromeNeuro Omega 3 Oil Nutritional Supplement
description: 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.
arm group label: Omega 3 Oil Supplementation
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sheldon Jordan, MD
role: Principal Investigator
affiliation: Neurological Associates of West Los Angeles
facility: 
country: United States
citation: 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.
PMID: 27720003
citation: 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.
PMID: 32154952
citation: Dietschy JM, Turley SD. Cholesterol metabolism in the brain. Curr Opin Lipidol. 2001 Apr;12(2):105-12. doi: 10.1097/00041433-200104000-00003.
PMID: 11264981
citation: 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.
PMID: 20546600
citation: 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.
PMID: 22627108
citation: 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.
PMID: 11145980
citation: 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.
PMID: 17805871
citation: 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.
PMID: 1420345
citation: 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.
PMID: 9753636
citation: 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.
PMID: 24973118
citation: 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.
PMID: 20658997
citation: 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.
PMID: 10693931
citation: 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.
PMID: 30992016
citation: 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.
PMID: 10878232
citation: 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.
PMID: 10051451
citation: 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.
PMID: 21236336
citation: 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.
PMID: 9895222
citation: 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.
PMID: 20655950
responsible party type: Sponsor
mesh term: Cognitive Dysfunction