Simvastatin as a neuroprotective treatment for Parkinson's disease: a double­blind, randomised, placebo controlled futility study in patients of moderate severity

Study ID: 19666
Short Title: Simvastatin as a neuroprotective treatment for moderate PD (PD STAT)
Organisation: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Location: Christchurch Hospital
Condition: Parkinson's disease
Main Specialty: Neurological disorders
Expected End Date: 31/12/2019
Postcode: BH1 3LT
Contact Name: Mary Smolen
Contact Email:
Active: Yes

Inclusion Criteria

1. Diagnosis of idiopathic PD.

2. Modified Hoehn and Yahr stage < 3.0 in the ON medication state.

3. Age 40­-90 years.

4. On dopaminergic treatment with wearing ff phenomenon.

5. Able to comply with study protocol and willing to attend necessary study visits.

Exclusion Criteria

1. Diagnosis or suspicion of other cause for parkinsonism.

2. Known abnormality on CT or MRI brain imaging considered to be causing symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with study protocol.

3. Concurrent dementia defined by MoCA score 31.

4. Prior intracerebral surgical intervention for PD including deep brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplantation.

5. Already actively participating in a research study that might conflict with this trial.

6.  Prior or current use of statins as a lipid-lowering therapy.

7.  Intolerance to statins.

8.  Untreated hypothyroidism.

9. End-stage renal disease (creatinine clearance 1.1 x upper limit of normal (ULN).

10. Aspartate transaminase (AST) or alanine transaminase (ALT) >1.1 x ULN.

11. Females who are pregnant or breastfeeding or of child­bearing potential and unwilling to use appropriate contraception methods whilst on trial treatment.

12. Currently taking any medication contraindicated with simvastatin use.

13. Any requirement for statin use.

14. Regular participation in endurance or high ­impact sports.

15. Unable to abstain from consumption of grapefruit ­based products.

Study summary:

Parkinson’s disease (PD) is a progressive, neurodegenerative condition affecting more than 127,000 people in the UK with a further 10,000 diagnosed each year.
No drug has been shown to slow or reverse the neurodegenerative
process of PD. All currently licensed therapies act as symptom­ relieving agents, but have a limited lifespan of effectiveness because of
neuronal loss.
Clinical trials of potential neuro-protective agents in PD are difficult to design due to the variability in disease, characteristics and rate of progression.
There is also no reliable biomarker for disease progression. There is some evidence to support a possible neuro-protective role for statins. This study has been designed to establish whether Simvastatin is of any value as a neuro-protective treatment in PD.
Eligible patients who consent to participate will be randomly allocated to receive either oral simvastatin capsules or a matched placebo over a two year period.
This study is double blind so neither the participant or research team will know which study treatment the participant is allocated.
Over a 26 month period, participants will attend scheduled study clinic visits and complete a number of validated assessments.
Participants will also be invited to complete questionnaires during this time. At the end of the study, the results of the assessments will be compared to determine the response of those receiving the oral simvastatin compared to those participants who received the matched placebo.

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