The Stanford Parkinson's Disease Plasma Study
Condition: Parkinson Disease(PD)
MeSH terms: Parkinson Disease
Intervention: Infusions of young plasma
Intervention description: Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Young Male Plasma

Summary:

      The purpose of this study is to demonstrate that young plasma infusions can be performed
      safely in patients with Parkinson's Disease (PD). Secondary outcomes will include behavioral
      and laboratory data that will support the next study that will inquire whether young plasma
      infusions improve or slow the progression of cognitive, mood and/or motor impairment and rate
      markers of the disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of clinically probable or established Parkinson's Disease (MDS criteria)

          -  Subject must be on a stable dose of dopaminergic medication and/or Deep Brain
             Stimulation (DBS) parameters for at least 4 weeks prior to screening and for the
             duration of the study

          -  Subject must be competent to sign consent

          -  Subject must be willing to commit to being available for testing and infusions for 6
             consecutive weeks (2 testing consecutive weeks, 4 infusion consecutive weeks) followed
             by two visits a month after final infusion.

          -  The availability of a study partner who knows the patient well and is willing to
             accompany the subject to all trial (optional if participant is able to consent and
             travel by self)

        Exclusion Criteria:

          -  The participation in any other interventional clinical trial

          -  The inability to travel to Stanford

          -  Inability to walk without assistance in the off or on medication state

          -  The clinically determined presence of dementia

          -  A clinical suspicion/diagnosis of Multiple System Atrophy (MSA), Progressive
             Supranuclear Palsy (PSP), Lewy Body Dementia (LBD), Essential Tremor (ET)

          -  Subject's pregnancy or likelihood of pregnancy within the next 6 months.

          -  Subject's positive test results 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

          -  Subject's medical history of:

        Stroke Anaphylaxis Gout- may cause an increase in uric acid 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 immunoglobulin A
        deficiency (by history)

          -  Subject's relation to medications or other treatments:

          -  Any concurrent use of an anticoagulant therapy. Antiplatelet drugs (e.g., aspirin or
             clopidogrel) are acceptable.

          -  The use of Inosine, which may alter urate levels

          -  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 interventional treatment trial for Parkinson'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.