Biomarker Assessments of Leukine During Treatment of Parkinson's Disease
Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
First, the investigators will determine the safety of a 24 month regimen of Leukine
administered as a weight-based dose at 3 µg/kg/day for 5 days (week), followed by a 2-day
holiday (weekend). This 24 month (n=10) pilot study will extend the prior 2 month observation
tests towards the goal of assessing the safety of Leukine for treatment of Parkinson's
disease (PD). 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).
Second, we will assess regimen tolerability administered in a dose reduction, from 6
µg/kg/day without interruption, to 3 µg/kg/day with 2 day drug holidays. The investigators
will examine over a time of 24 months, effects of treatment on defined adaptive immune
deficits in PD as measured by analysis of peripheral blood mononuclear cells collected
before, during, and after cessation of Leukine administration. Individual T cell parameters
will be assessed and will include links between T cell function and subset analyses and
clinical neurological signs and symptoms. In addition, the functional stability of the immune
deficits will be assess in PD by examining T cell subsets in PD patients in this study
against prior results. The investigators will also determine whether the 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.