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Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease

NCT03242499 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-10-17

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

DRUG

Lovastatin

Lovastatin 80mg or placebo use for 48 weeks.

DRUG

Placebo

placebo for 48 weeks

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chin-Hsien Lin, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03242499 on ClinicalTrials.gov