<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/NCT02211560</url>
  </required_header>
  <id_info>
    <org_study_id>Vayacog_002</org_study_id>
    <nct_id>NCT02211560</nct_id>
  </id_info>
  <brief_title>Investigating a Phosphatidylserine Based Dietary Approach for the Management of Mild Cognitive Impairment</brief_title>
  <official_title>A, Multi-center, Double-blind, Randomized, Placebo-controlled Study for the Efficacy of Phosphatidylserine in Mild Cognitive Impairment (MCI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enzymotec</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Enzymotec</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to evaluate the efficacy and safety of phosphatidylserine (PS) on&#xD;
      cognitive abilities in MCI&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to difficulties in patient recruitment&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 25, 2017</completion_date>
  <primary_completion_date type="Actual">December 25, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in change in the Selective Reminding Test (SRT) between the study groups.</measure>
    <time_frame>baseline, 3, 6,12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mini Mental State Examination (MMSE)</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Computerized Neurological battery test (NBT)</measure>
    <time_frame>baseline, 6, 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transition rate to dementia according to DSM-4 criteria</measure>
    <time_frame>baseline, 3, 6, 12, 18 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini Sleep Questionnaire (MSQ)</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Anxiety Rating Scale (HAM-A).</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Selective Reminding Test (SRT)</measure>
    <time_frame>18 and 24 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety of phosphatidylserine versus placebo treatment</measure>
    <time_frame>baseline, 3, 6, 12, 18 and 24 months</time_frame>
    <description>Clinical laboratory safety data will be collected at baseline and 24 months. Vital signs will be measured at baseline, 12 and 24 months. Adverse events (including changes to concomitant medications) will be documented at all study visits (i.e baseline, 3, 6, 12, 18 and 24 months).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Identical looking cellulose capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phosphatidylserine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phosphatidylserine-omega-3, DHA enriched</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phosphatidylserine</intervention_name>
    <arm_group_label>Phosphatidylserine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age greater than or equal to 65 and less than or equal to 85 years.&#xD;
&#xD;
          2. Formal education greater than or equal to 10 years.&#xD;
&#xD;
          3. Male or female with a diagnosis of Mild Cognitive Impairment (MCI) 3. Male or female&#xD;
             with a diagnosis of Mild Cognitive Impairment (MCI) as defined by Peterson, according&#xD;
             to The following:&#xD;
&#xD;
             3.1 Clinical Dementia Rating Scale total score (CDR) ≤0.5, and score of each one of&#xD;
             the six categories (&quot;box scores&quot;) ≤ 1. 3.2 Mini Mental State Exam &gt; 24 3.3 Verbal&#xD;
             Paired-Associated Learning test score according to the following ages: Ages 65-70 less&#xD;
             than or equal to 18 Ages 71-85* less than or equal to 17&#xD;
&#xD;
             *Eligibility of subjects aged between 70 and 71 (i.e., 70.1) will be evaluated&#xD;
             according to 71-85 age group score.&#xD;
&#xD;
          4. Adequate vision, hearing, and literacy ability to allow for neuropsychological&#xD;
             testing.&#xD;
&#xD;
          5. Able and willing to perform all study procedures.&#xD;
&#xD;
          6. Ability to provide written consent signed by the subject&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any significant neurological condition or disorder (e.g., seizure disorder, epilepsy,&#xD;
             brain tumors, stroke, etc.) that could cause cognitive deterioration other than&#xD;
             suspected MCI.&#xD;
&#xD;
          2. Any medical condition or disorder that could produce cognitive deterioration (i.e.,&#xD;
             renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine,&#xD;
             metabolic or hematological disturbances) unless well controlled for at least 3 months.&#xD;
&#xD;
          3. Clinically significant abnormal serum TSH and/or B-12 and/or folic acid levels below&#xD;
             the normal range.&#xD;
&#xD;
          4. History of any infective or inflammatory brain disease including viral, fungal or&#xD;
             syphilitic etiologies.&#xD;
&#xD;
          5. Head trauma or injury immediately preceding cognitive deterioration, unless over 2&#xD;
             years have passed since full cognitive and functional recovery.&#xD;
&#xD;
          6. Depression at screening as assessed by Geriatric Depression Scale-short version (score&#xD;
             ≥5)&#xD;
&#xD;
          7. Current suicidality at screening by Columbia Suicidality Severity Rating Scale.&#xD;
&#xD;
          8. Dementia by DSM-IV criteria.&#xD;
&#xD;
          9. Concomitant use of medications with potent psychotropic properties (e.g.&#xD;
             antipsychotics, ADHD treatments, lithium carbonate, anti-epileptic drugs such as&#xD;
             Gabapentin). Sedating antihistamines are allowed if administered last dose is&#xD;
             administered at least 12 hours before cognitive testing. Usage of prescription or&#xD;
             nonprescription antidepressant agents, lipid lowering medications, and&#xD;
             anti-hypertensive medications with a stable dosage for more than 2 months prior study&#xD;
             entry is permitted.&#xD;
&#xD;
         10. Concomitant use of any medications approved for the symptomatic treatment of dementia&#xD;
             due to AD (e.g., NMDA, acetyl choline esterase inhibitors)&#xD;
&#xD;
         11. Use within 3 weeks prior to study entry of any medications with any anti-cholinergic&#xD;
             effect (e.g. Atropine, Scopolamine, Tolterodine, Hyoscyamine, Biperiden, Benzatropine,&#xD;
             Trihexyphenidyl, Oxybutynin).&#xD;
&#xD;
         12. Use within 4 weeks prior to the study entry of dietary supplements containing DHA,&#xD;
             EPA, Phosphatidylserine, Phosphatidylcholine (e.g. Krill oil, Lecithin), or&#xD;
             alpha-glycerphosphocholine (GPC).&#xD;
&#xD;
         13. Use within 4 weeks prior to the study entry of medical foods indicated for cognitive&#xD;
             or memory impairment [e.g. Axona, Cerefolin, CerefolinNAC, Souvenaid].&#xD;
&#xD;
         14. Concomitant use of any supplements containing ingredients with nootropic or&#xD;
             vasodilator properties (e.g., Ginkgo Biloba, Vinpocetine, Piracetam, high energy&#xD;
             supplements).&#xD;
&#xD;
         15. Use of an investigational drug within the last 30 days.&#xD;
&#xD;
         16. Allergic reaction or sensitivity to marine products (fish/seafood) and/or soy.&#xD;
&#xD;
         17. Any known condition which in the opinion of the investigator may be possibly causing&#xD;
             cognitive impairment other than AD (mania, alcohol or substance abuse, mental&#xD;
             retardation, bipolar disorder, panic disorder, obsessive compulsive disorder,&#xD;
             post-traumatic stress disorder, psychotic disorder, major psychiatric disorder&#xD;
             preceding dementia onset or affecting brain function, major surgery ) and/or limits&#xD;
             the successful trial completion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yehudit Aharon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam medical center, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New West Physicians, PC</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Jewish Health Systems</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APG Research LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Clinical Trials</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Enhancement Center of America</name>
      <address>
        <city>Eatontown</city>
        <state>New Jersey</state>
        <zip>07724,</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princeton Medical Institute</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrative Clinical Trials, LLC</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical Research Network</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128,</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Center for Clinical Research</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam medical center, Israel</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ichilov medical center</name>
      <address>
        <city>Tel-Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02211560
org study id: Vayacog_002
nct id: NCT02211560
lead sponsor: 
has dmc: No
The primary objective is to evaluate the efficacy and safety of phosphatidylserine (PS) on
      cognitive abilities in MCI
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Difference in change in the Selective Reminding Test (SRT) between the study groups.
time frame: baseline, 3, 6,12 months
measure: Mini Mental State Examination (MMSE)
time frame: baseline, 12 and 24 months
measure: Computerized Neurological battery test (NBT)
time frame: baseline, 6, 12 and 24 months
measure: Transition rate to dementia according to DSM-4 criteria
time frame: baseline, 3, 6, 12, 18 and 24 months
measure: Mini Sleep Questionnaire (MSQ)
time frame: baseline, 12 and 24 months
measure: Hamilton Anxiety Rating Scale (HAM-A).
time frame: baseline, 12 and 24 months
measure: Selective Reminding Test (SRT)
time frame: 18 and 24 months
measure: Safety of phosphatidylserine versus placebo treatment
time frame: baseline, 3, 6, 12, 18 and 24 months
description: Clinical laboratory safety data will be collected at baseline and 24 months. Vital signs will be measured at baseline, 12 and 24 months. Adverse events (including changes to concomitant medications) will be documented at all study visits (i.e baseline, 3, 6, 12, 18 and 24 months).
arm group label: Placebo
arm group type: Placebo Comparator
description: Identical looking cellulose capsules
arm group label: Phosphatidylserine
arm group type: Experimental
description: Phosphatidylserine-omega-3, DHA enriched
intervention type: Other
intervention name: Phosphatidylserine
arm group label: Phosphatidylserine
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yehudit Aharon, MD
role: Principal Investigator
affiliation: Rambam medical center, Israel
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Israel
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction