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

Primary Purpose

Mild-To-Moderate Alzheimer's Disease, Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plasma
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild-To-Moderate Alzheimer's Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Young Donor Plasma

Arm Description

Subjects will receive 1 unit of plasma, once weekly for 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change on the 13-item ADAS-Cog
Change on the Trail-Making Test
Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB)
Change on the Functional Activities Questionnaire (FAQ)
Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)
Change on the Geriatric Depression Scale
Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q)

Full Information

First Posted
September 25, 2014
Last Updated
October 9, 2017
Sponsor
Stanford University
Collaborators
Alkahest, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02256306
Brief Title
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study
Acronym
PLASMA
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 Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Alkahest, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild-To-Moderate Alzheimer's Disease, Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Young Donor Plasma
Arm Type
Experimental
Arm Description
Subjects will receive 1 unit of plasma, once weekly for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Plasma
Intervention Description
1 unit of Plasma From Young Donors (Male, aged 30 or younger)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change on the 13-item ADAS-Cog
Time Frame
9 weeks
Title
Change on the Trail-Making Test
Time Frame
9 weeks
Title
Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB)
Time Frame
9 weeks
Title
Change on the Functional Activities Questionnaire (FAQ)
Time Frame
9 weeks
Title
Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)
Time Frame
9 weeks
Title
Change on the Geriatric Depression Scale
Time Frame
9 weeks
Title
Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time Frame
9 weeks
Other Pre-specified Outcome Measures:
Title
Change in functional connectivity in the default mode network as assessed by resting state functional MRI
Time Frame
9 weeks
Title
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
Title
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
Title
Differential effect of therapy on above outcomes as a function of ApoE genotype
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30383097
Citation
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. 2019 Jan 1;76(1):35-40. doi: 10.1001/jamaneurol.2018.3288.
Results Reference
derived

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The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study

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