Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease
Status:
Not yet recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
Summary
Investigators will evaluate the safety of a 48 week regimen of Leukine administered as a
weight-based dose at 3 ug/kg/ day for 5 days followed by a 2-day holiday. This 48 week long
study will extend the prior biomarker evaluations observed in a previous study. Clinical
signs and symptoms will be measured by personal well-being, physical, and neurological
examinations (UPDRS Parts I, II, III, and IV assessments) and blood tests (CBC with
differential, total T cell count, and a comprehensive metabolic sera panel). Leukapheresis
will be performed to collect large numbers of immune cells for biomarker testing and immune
phenotyping. Additionally, the investigators will determine whether immune deficits of PD are
consistent during baseline data collection, and the potential Leukine-induced motor control
and mobility improvements will be determined by UPDRS part I, II, III, and IV scores off
treatment and on treatment.