The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study

Not Recruiting

Trial ID: NCT02256306

Purpose

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

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

Stanford Investigator(s)

Sharon Sha, MD, MS
Sharon Sha, MD, MS

Clinical Professor, Neurology & Neurological Sciences

Eligibility


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.

Intervention(s):

other: Plasma

other: Plasma

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ethan Solomon, MA
650-850-1853