Status:
UNKNOWN
Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-90 years
Phase:
PHASE2
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 tri...
Detailed Description
This is a Phase 2, single-center, randomized, double-blind, placebo-controlled, parallel-group, 2-arm study in patients with mild to moderate PD. There will be three phases to the study. An initial 12...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
May 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03242499
Start Date
May 15 2017
End Date
December 31 2019
Last Update
October 17 2017
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100