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

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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

September 25, 2014
October 3, 2014
October 10, 2017
September 2014
February 2017   (Final data collection date for 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. [ Time Frame: 9 weeks ]
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: 18 weeks ]
Complete list of historical versions of study NCT02256306 on ClinicalTrials.gov Archive Site
  • Change on the 13-item ADAS-Cog [ Time Frame: 9 weeks ]
  • Change on the Trail-Making Test [ Time Frame: 9 weeks ]
  • Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB) [ Time Frame: 9 weeks ]
  • Change on the Functional Activities Questionnaire (FAQ) [ Time Frame: 9 weeks ]
  • Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: 9 weeks ]
  • Change on the Geriatric Depression Scale [ Time Frame: 9 weeks ]
  • Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: 9 weeks ]
  • Change on the 13-item ADAS-Cog [ Time Frame: 18 weeks ]
  • Change on the Trail-Making Test [ Time Frame: 18 weeks ]
  • Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB) [ Time Frame: 18 weeks ]
  • Change on the Functional Activities Questionnaire (FAQ) [ Time Frame: 18 weeks ]
  • Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: 18 weeks ]
  • Change on the Geriatric Depression Scale [ Time Frame: 18 weeks ]
  • Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: 18 weeks ]
  • Change in functional connectivity in the default mode network as assessed by resting state functional MRI [ Time Frame: 9 weeks ]
  • 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 ]
  • 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 ]
  • Differential effect of therapy on above outcomes as a function of ApoE genotype [ Time Frame: 9 weeks ]
  • Change in functional connectivity in the default mode network as assessed by resting state functional MRI [ Time Frame: 18 weeks ]
  • Change in plasma biomarkers associated with AD Differential effect of therapy on above outcomes as a function of ApoE genotype [ Time Frame: 18 weeks ]
 
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Mild-To-Moderate Alzheimer's Disease
  • Alzheimer's Disease
Other: Plasma
1 unit of Plasma From Young Donors (Male, aged 30 or younger)
Experimental: Young Donor Plasma
Subjects will receive 1 unit of plasma, once weekly for 4 weeks.
Intervention: Other: Plasma
Sha SJ, Deutsch GK, Tian L, Richardson K, Coburn M, Gaudioso JL, Marcal T, Solomon E, Boumis A, Bet A, Mennes M, van Oort E, Beckmann CF, Braithwaite SP, Jackson S, Nikolich K, Stephens D, Kerchner GA, Wyss-Coray T. Safety, Tolerability, and Feasibility of Young Plasma Infusion in the Plasma for Alzheimer Symptom Amelioration Study: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 29. doi: 10.1001/jamaneurol.2018.3288. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Same as current
February 2017
February 2017   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
50 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02256306
30350
No
Not Provided
Not Provided
Sharon Sha, Stanford University
Stanford University
Alkahest, Inc.
Not Provided
Stanford University
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP