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

NCT03242499 | Unknown Phase 2 DMC

• 1 other identifier: NCTRC201702
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes of MDS-UPDRS Part III (motor subscale) from baseline to week 48

  Measure the motor symptoms severity changes of Parkinson's disease

  After informed consent form is completed, each patient will participate in the study for up to 48 weeks (a Screening Period of ≤12 weeks, followed by a Baseline Visit, 48 weeks of double-blind treatment, and a 4-week post-dose Safety Follow-up Visit

Study Arms (2)

Active

EXPERIMENTAL

Lovastatin 80mg per day for 48 weeks.

Drug: Lovastatin

Placebo

PLACEBO COMPARATOR

Placebo 80mg per day for 48 weeks.

Drug: Placebo

Interventions

Lovastatin DRUG

Lovastatin 80mg or placebo use for 48 weeks.

Also known as: LOVASTATIN "YUNG SHIN"

Active

Placebo DRUG

placebo for 48 weeks

Placebo

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is informed and given ample time and opportunity to think about his/her participation in this study and has given his/her written informed consent on an Independent Review Board (IRB) approved consent form.
• Patient is considered reliable and capable of adhering to the protocol, visit schedule, or medication administration according to the judgment of the investigator.
• Patient has a documented history of idiopathic PD consistent with the UK Parkinson's Disease Society Brain Bank Diagnostic criteria \[14\] prior to the Screening Visit.
• Modified Hoehn and Yahr stage =1 in the off medication state (stop medications for 1 month)
• Patients did not previously receive any anti-parkinsonism medications (drug naïve) or had stopped medications for at least 1 month.
• Age 30-90 years

You may not qualify if:

• Patient has any form of secondary or atypical parkinsonism (e.g., drug-induced, post stroke).
• Patient has known abnormality on brain CT or MRI imaging considered to be causing symptoms or signs of neurological dysfunction.
• Prior intracerebral surgical intervention for PD including deep brain stimulation (DBS).
• Prior or current use of statins as a lipid lowering therapy
• End stage renal disease (creatinine clearance eGFR \<30 mL/min) or history of severe cardiac disease (angina, myocardial infarction or cardiac surgery in preceding two years)
• Abnormal liver function with aspartate transaminase (AST) or alanine transaminase (ALT) \>2 x upper normal limit.
• Creatine kinase (CK) \>2 x upper normal limit of normal.
• History of myopathy or rhabdolyolysis.
• Females who are pregnant or breast feeding.
• Patient has a history of chronic alcohol or drug abuse within the last 2 years.
• Exposure to neuroleptics (antipsychotic drugs) for more than 1 month within the past 2 years, or any exposure within the past year (except for quetiapine).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Chin-Hsien Lin, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Hsien Lin, MD, PhD

CONTACT

886-2-23123456; chlin@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 8, 2017
• Study Start: May 15, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)