The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study

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

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

Intervention / Treatment
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* Other: Plasma


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Young Donor Plasma<br>Subjects will receive 1 unit of plasma, once weekly for 4 weeks. | Other: Plasma<br>* 1 unit of Plasma From Young Donors (Male, aged 30 or younger)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on the 13-item ADAS-Cog |  | 9 weeks | 
| Change on the Trail-Making Test |  | 9 weeks | 
| Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB) |  | 9 weeks | 
| Change on the Functional Activities Questionnaire (FAQ) |  | 9 weeks | 
| Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) |  | 9 weeks | 
| Change on the Geriatric Depression Scale |  | 9 weeks | 
| Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q) |  | 9 weeks |