NCT02787590

Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease

Simvastatin as a Neuroprotective Treatment for Parkinson's Disease: a Double-blind, Randomised, Placebo Controlled Futility Study in Patients of Moderate Severity.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: University Hospital Plymouth NHS Trust · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Participants are randomly allocated to one of two treatment groups. In one group, participants are given capsules of simvastatin to take orally (by mouth) for 24 months. In the other group, participants are given placebo (dummy) capsules to take orally for 24 months. At the start of the study, when they receive their medication, participants complete a number of questionnaires and motor (movement) tests (a walking test and a finger tapping test). Participants in both groups also attend a further 6 clinic visits after 1, 6, 12, 18 and 24 and 26 months, where they are asked about their health and any medication they are taking, as well as repeating the questionnaires and motor tests. For 4 of the clinic visits, the participants will be asked to attend in the 'OFF medication' state (having omitted their usual PD medication) so that the researchers can get a true picture of their disease without it being masked by their normal medication.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Simvastatin
DRUG	Matched Placebo (for Simvastatin)

Timeline

• Start date: 2016-03-08
• Primary completion: 2019-11-01
• Completion: 2020-12-31
• First posted: 2016-06-01
• Last updated: 2021-10-18

Locations

24 sites across 1 country: United Kingdom