Topic: Dementias and neurodegeneration
Conditions
Interventions
Participants in this study will be randomly allocated to one of two treatment groups in a 1:1 ratio:
Intervention group: Participants will receive oral simvastatin capsules to take daily for 24 months
the maximum supply provided will be a 6 month supply. Bottles containing 100 capsules of either 40mg simvastatin or matched placebo will be issued to the participants.
Over a 26 month period, partic
Sponsors
Plymouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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-off phenomenon 5. Able to comply with study protocol and willing to attend necessary study visits
Exclusion criteria
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 5. Prior intracerebral surgical intervention for PD including deep brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplantation 6. Already actively participating in a research study that might conflict with this trial 7. Prior or current use of statins as a lipid lowering therapy 8. Intolerance to statins 9. Untreated hypothyroidism 10. End stage renal disease (creatinine clearance 1.1 x upper limit of normal (ULN) 14. Aspartate transaminase (AST) or alanine transaminase (ALT) >1.1 x ULN 15. Females who are pregnant or breast feeding or of childbearing potential and unwilling to use appropriate contraception methods whilst on trial treatment 16. Currently taking any medication contraindicated with simvastatin use 17. Any requirement for statin use 18. Regular participation in endurance or high impact sports 19. Unable to abstain from consumption of grapefruit based products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient motor skills are determined using the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III) in the OFF state at 12 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The overall impact of PD on the participant is assessed using the MDS-UPDRS total score in the practically defined ON state at 12 and 24 months 2. The impact of PD on activities of daily living is assessed using the MDS-UPDRS part II subscale score in the practically defined ON state at 12 and 24 months 3. Motor skills are assessed using timed motor tests (finger tapping and timed walk test (10MWT)) in the OFF state at 12 and 24 months 4. Depression is assessed using the Montgomery and Asberg Depression Rating Scale (MADRS) at 12 and 24 months 5. Cognition is assessed using the Addenbrooke’s Cognitive Assessment-III (ACE-III) at 12 and 24 months 6. The presence of the non-motor features of PD is captured using the Non-Motor Symptom assessment scale (NMSS) at 12 and 24 months 7. A PD-specific health status is assessed using the Parkinson’s disease Questionnaire (PDQ-39) at 12 and 24 months 8. Changes in PD medication are measured by capturing a levodopa-equivalent dose (LED) at 12 and 24 months 9. Cholesterol levels are captured using total, HDL, LDL, and total/HDL ratio results at 12 and 24 months 10. The presence of PD-specific pain is captured using the King’s PD pain scale (KPPS) at 12 and 24 months 11. A current overall health status is captured using the EuroQoL 5D-5L (EQ-5D-5L) health status questionnaire at 12 and 24 months 12. The safety and tolerability of trial medication is assessed by adverse events (AEs) review at 12 and 24 months 13. The incidence of diabetes mellitus is assessed at 24 months using a glycated haemoglobin (HbA1c) level of 6.5% (48mmol/mol) as diagnostic of diabetes mellitus (WHO 2011) | — |
Countries
England, United Kingdom
Contacts
Public ContactDoug Webb
Outcome results
None listed