This study will do a preliminary evaluation of a possible treatment for mild-to-moderate Parkinson's disease. Patients will be treated with either transfusions of plasma from young donors. or with placebo transfusions. In the following several months, Parkinson's symptoms will be monitored and compared for the two groups.
This is a double-blind placebo controlled trial, designed to evaluate the efficacy of plasma from volunteer donors of ages 18-25. This young fresh frozen plasma (yFFP) will be given intravenously in two doses of 12.5 ml/kg each, with 40-56 hours between doses. In the following 24 weeks, Parkinson's symptoms will be monitored using the short version of the Stanford Presenteeism Scale (SPS-6), and a modified version of the UPDRS scale.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
22
12.5 ml/kg intravenous Spectrum Plasma yFFP, per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment.
12.5 ml/kg intravenous 0.9% sodium chloride with 0.1% riboflavin , per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment.
The Neurology Center
Houston, Texas, United States
Changes in Physician assessment
Unified Parkinson Disease Rating Scale (UPDRS)
Time frame: Two weeks prior to infusion, at one-three-six months post-infusion
Patient assessment
Changes in Stanford Presenteeism Scale (SPS)
Time frame: Two weeks prior to infusion, at one-three-six months post-infusion
Stability of administration
Adverse events (if any)
Time frame: At the time of infusions, day 1 and day 2
Factors predicting a beneficial response
Patient Global Impression of change
Time frame: After the last participant's final contact at 6 months
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