Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease
Status:
Unknown status
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
Summary
Background: Recent evidence has shown that statins, especially lipophilic statins, may have a
neuroprotective benefit in Parkinson's disease (PD). We aim to perform a randomized
placebo-controlled trial evaluating the disease-modifying efficacy of lovastatin in patients
with early stage PD.
Methods and Study Design: This study will be a phase II, single-center, double-blind,
randomized, placebo-controlled parallel-group study. In this trial, we are going to examine
the possibility that lovastatin, a highly potent lipophilic statin, has disease-modifying
effects in PD. We are going to enroll 80 patients with early stage PD patients. Subjects will
then be randomized to a 48-week double-blind treatment period of lovastatin 80mg/day or
placebo. Primary endpoints are changes in motor severity based on Movement Disorder
Society-Unified Parkinson's Disease Rating Scale motor sub-score (MDS-UPDRS part III, with
higher numbers indicating more severe disease). During the follow-up period, the dose of
anti-parkinsonism could be added if both the patients and doctors thought the clinical
condition deteriorated. Changes in PD medication as measured by levodopa-equivalent dose
(LED) will be recorded at each visit. The secondary endpoints measured include MDS-UPDRS
total scores, Part I and Part II sub-scores, the timing and dose of added anti-parkinsonism
medication during the treatment period, the changes of 18F-DOPA PET uptake and MMSE scores,
and global impression scale (GCI) of patients and investigators at the end of the study.
Expected results: We hypothesize that lovastatin would slow down both motor and cognitive
symptoms deterioration and dopaminergic neuronal degeneration in patients with early stage
PD.
Importance of the study: Our study will provide Class II evidence that intensive lipid
lowering with lovastatin 80 mg/day decrease the disease progression in patients with early
stage PD.