<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/NCT02256306</url>
  </required_header>
  <id_info>
    <org_study_id>30350</org_study_id>
    <nct_id>NCT02256306</nct_id>
  </id_info>
  <brief_title>The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study</brief_title>
  <acronym>PLASMA</acronym>
  <official_title>The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alkahest, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered&#xD;
      Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Number of participants with adverse events as a measure of safety and tolerability, and number of subjects who comply with the research protocol as a measure of feasibility.</measure>
    <time_frame>9 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change on the 13-item ADAS-Cog</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on the Trail-Making Test</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB)</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on the Functional Activities Questionnaire (FAQ)</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on the Geriatric Depression Scale</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q)</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in functional connectivity in the default mode network as assessed by resting state functional MRI</measure>
    <time_frame>9 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Compositional assessment of plasma using in vitro analytical methods. The goal is to assess plasma components that might be associated with aging and/or Alzheimer's disease</measure>
    <time_frame>9 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>In vivo assessment of plasma samples to determine their potential histological effects on the hippocampus and their potential behavioral effects in animal models of cognition</measure>
    <time_frame>9 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Differential effect of therapy on above outcomes as a function of ApoE genotype</measure>
    <time_frame>9 weeks</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Mild-To-Moderate Alzheimer's Disease</condition>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Young Donor Plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive 1 unit of plasma, once weekly for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Plasma</intervention_name>
    <description>1 unit of Plasma From Young Donors (Male, aged 30 or younger)</description>
    <arm_group_label>Young Donor Plasma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of probable Alzheimer's disease (NIA-AA criteria)&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE) score 12-24&#xD;
&#xD;
          -  Availability of a study partner who knows the patient well and is willing to accompany&#xD;
             the subject to all trial visits, to participate in questionnaires and to complete&#xD;
             daily journal assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or unwilling to use adequate birth control method for duration of and 6&#xD;
             months beyond study participation&#xD;
&#xD;
          -  Positive for Hepatitis B, Hepatitis C or HIV at screening&#xD;
&#xD;
          -  Any other condition or situation that the investigator believes may interfere with the&#xD;
             safety of the subject or the intent and conduct of the study&#xD;
&#xD;
          -  Related to medical history:&#xD;
&#xD;
               -  Stroke&#xD;
&#xD;
               -  Anaphylaxis&#xD;
&#xD;
               -  Prior adverse reaction to any human blood product&#xD;
&#xD;
               -  Any history of a blood coagulation disorder or hypercoagulability&#xD;
&#xD;
               -  Congestive heart failure&#xD;
&#xD;
               -  Uncontrolled hypertension&#xD;
&#xD;
               -  Renal failure&#xD;
&#xD;
               -  Prior intolerance to intravenous fluids&#xD;
&#xD;
               -  Recent history of uncontrolled atrial fibrillation&#xD;
&#xD;
               -  IgA deficiency (by history)&#xD;
&#xD;
          -  Related to medications or other treatments:&#xD;
&#xD;
               -  Any concurrent use of an anticoagulant therapy. Antiplatelet drugs (e.g., aspirin&#xD;
                  or clopidogrel) are acceptable&#xD;
&#xD;
               -  Initiation or change in the dosage of a cholinesterase inhibitor or memantine&#xD;
                  during the trial. A participant already on a cholinesterase inhibitor or&#xD;
                  memantine must be on a stable dose for at least one month prior to Screening&#xD;
&#xD;
               -  Concurrent participation in another treatment trial for Alzheimer's disease. If&#xD;
                  there was prior participation, the last dose of the investigational agent must&#xD;
                  have been at least 6 months prior to Screening&#xD;
&#xD;
               -  Treatment with any human blood product, including intravenous immunoglobulin,&#xD;
                  during the 6 months prior to Screening or during the trial&#xD;
&#xD;
               -  Concurrent daily treatment with benzodiazepines, typical or atypical&#xD;
                  antipsychotics, long-acting opioids, or other medications that, in the&#xD;
                  investigator's opinion, interfere with cognition. Intermittent treatment with&#xD;
                  short-acting benzodiazepines or atypical antipsychotics may be permitted,&#xD;
                  provided that no dose is administered within the 72 hours preceding any cognitive&#xD;
                  assessment&#xD;
&#xD;
          -  Related to magnetic resonance imaging:&#xD;
&#xD;
               -  Claustrophobia&#xD;
&#xD;
               -  Any metallic surgical implant, like a pacemaker or clip that is incompatible with&#xD;
                  3T MRI.&#xD;
&#xD;
        Certain metallic implants like joint replacements may be permitted, provided that specific&#xD;
        manufacturer specifications are available and that the device is known to be safe for 3T&#xD;
        MRI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Sharon Sha</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT02256306
org study id: 30350
nct id: NCT02256306
lead sponsor: 
collaborator: 
has dmc: No
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered
      Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse events as a measure of safety and tolerability, and number of subjects who comply with the research protocol as a measure of feasibility.
time frame: 9 weeks
measure: Change on the 13-item ADAS-Cog
time frame: 9 weeks
measure: Change on the Trail-Making Test
time frame: 9 weeks
measure: Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB)
time frame: 9 weeks
measure: Change on the Functional Activities Questionnaire (FAQ)
time frame: 9 weeks
measure: Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)
time frame: 9 weeks
measure: Change on the Geriatric Depression Scale
time frame: 9 weeks
measure: Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q)
time frame: 9 weeks
measure: Change in functional connectivity in the default mode network as assessed by resting state functional MRI
time frame: 9 weeks
measure: Compositional assessment of plasma using in vitro analytical methods. The goal is to assess plasma components that might be associated with aging and/or Alzheimer's disease
time frame: 9 weeks
measure: In vivo assessment of plasma samples to determine their potential histological effects on the hippocampus and their potential behavioral effects in animal models of cognition
time frame: 9 weeks
measure: Differential effect of therapy on above outcomes as a function of ApoE genotype
time frame: 9 weeks
arm group label: Young Donor Plasma
arm group type: Experimental
description: Subjects will receive 1 unit of plasma, once weekly for 4 weeks.
intervention type: Other
intervention name: Plasma
description: 1 unit of Plasma From Young Donors (Male, aged 30 or younger)
arm group label: Young Donor Plasma
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Sharon Sha
investigator title: Principle Investigator
mesh term: Alzheimer Disease