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The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (PLASMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02256306
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : October 10, 2017
Sponsor:
Collaborator:
Alkahest, Inc.
Information provided by (Responsible Party):
Sharon Sha, Stanford University

Study Description
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Brief Summary:
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease

Condition or disease Intervention/treatment Phase
Mild-To-Moderate Alzheimer's Disease Alzheimer's Disease Other: Plasma Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Young Donor Plasma
Subjects will receive 1 unit of plasma, once weekly for 4 weeks.
 Other: Plasma
1 unit of Plasma From Young Donors (Male, aged 30 or younger)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change on the 13-item ADAS-Cog [ Time Frame: 9 weeks ]
  2. Change on the Trail-Making Test [ Time Frame: 9 weeks ]
  3. Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB) [ Time Frame: 9 weeks ]
  4. Change on the Functional Activities Questionnaire (FAQ) [ Time Frame: 9 weeks ]
  5. Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: 9 weeks ]
  6. Change on the Geriatric Depression Scale [ Time Frame: 9 weeks ]
  7. Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: 9 weeks ]

Other Outcome Measures:
  1. Change in functional connectivity in the default mode network as assessed by resting state functional MRI [ Time Frame: 9 weeks ]
  2. 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 ]
  3. 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 ]
  4. Differential effect of therapy on above outcomes as a function of ApoE genotype [ Time Frame: 9 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's disease (NIA-AA criteria)
  • Mini-Mental State Examination (MMSE) score 12-24
  • Availability of a study partner who knows the patient well and is willing to accompany the subject to all trial visits, to participate in questionnaires and to complete daily journal assessments

Exclusion Criteria:

  • Pregnancy or unwilling to use adequate birth control method for duration of and 6 months beyond study participation
  • Positive for Hepatitis B, Hepatitis C or HIV at screening
  • Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study

  • Related to medical history:

    • Stroke
    • Anaphylaxis
    • Prior adverse reaction to any human blood product
    • Any history of a blood coagulation disorder or hypercoagulability
    • Congestive heart failure
    • Uncontrolled hypertension
    • Renal failure
    • Prior intolerance to intravenous fluids
    • Recent history of uncontrolled atrial fibrillation
    • IgA deficiency (by history)

  • Related to medications or other treatments:

    • Any concurrent use of an anticoagulant therapy. Antiplatelet drugs (e.g., aspirin or clopidogrel) are acceptable
    • Initiation or change in the dosage of a cholinesterase inhibitor or memantine during the trial. A participant already on a cholinesterase inhibitor or memantine must be on a stable dose for at least one month prior to Screening
    • Concurrent participation in another treatment trial for Alzheimer's disease. If there was prior participation, the last dose of the investigational agent must have been at least 6 months prior to Screening
    • Treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to Screening or during the trial
    • Concurrent daily treatment with benzodiazepines, typical or atypical antipsychotics, long-acting opioids, or other medications that, in the investigator's opinion, interfere with cognition. Intermittent treatment with short-acting benzodiazepines or atypical antipsychotics may be permitted, provided that no dose is administered within the 72 hours preceding any cognitive assessment

  • Related to magnetic resonance imaging:

    • Claustrophobia
    • Any metallic surgical implant, like a pacemaker or clip that is incompatible with 3T MRI.

Certain metallic implants like joint replacements may be permitted, provided that specific manufacturer specifications are available and that the device is known to be safe for 3T MRI.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256306


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Alkahest, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sharon Sha, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02256306    
Other Study ID Numbers: 30350
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders