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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03242499
• Date of registration: 01/08/2017
• Prospective Registration: No
• Primary sponsor: National Taiwan University Hospital
• Public title: Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease
• Scientific title: Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease: a Single-center, Double-blind, Placebo-controlled Randomized Trial
• Date of first enrolment: May 15, 2017
• Target sample size: 80
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03242499
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Chin-Hsien Lin, MD,PhD

• Name: Chin-Hsien Lin, MD, PhD

• Name: Chin-Hsien Lin, MD, PhD
• Affiliation: National Taiwan University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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).



Age minimum: 30 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Lovastatin

Drug: Placebo

Primary Outcome(s)

Changes of MDS-UPDRS Part III (motor subscale) from baseline to week 48 [Time Frame: 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]

Secondary ID(s)

NCTRC201702

Source(s) of Monetary Support

Please refer to primary and secondary sponsors