Abstract
BackgroundFalls are a common complication of Parkinson’s disease. There is a need for new therapeutic options to target this debilitating aspect of the disease. Cholinergic deficit has been shown to contribute to both gait and cognitive dysfunction seen in the condition. Potential benefits of using cholinesterase inhibitors were shown during a single centre phase 2 trial. The aim of this trial is to evaluate the effectiveness of a cholinesterase inhibitor on fall rate in people with idiopathic Parkinson’s disease.MethodsThis is a multi-centre, double-blind, randomised placebo-controlled trial in 600 people with idiopathic Parkinson’s disease (Hoehn and Yahr stages 1 to 4) with a history of a fall in the past year. Participants will be randomised to two groups, receiving either transdermal rivastigmine or identical placebo for 12 months. The primary outcome is the fall rate over 12 months follow-up. Secondary outcome measures, collected at baseline and 12 months either face-to-face or via remote video/telephone assessments, include gait and balance measures, neuropsychiatric indices, Parkinson’s motor and non-motor symptoms, quality of life and cost-effectiveness.DiscussionThis trial will establish whether cholinesterase inhibitor therapy is effective in preventing falls in Parkinson’s disease. If cost-effective, it will alter current management guidelines by offering a new therapeutic option in this high-risk population.Trial registrationREC reference: 19/SW/0043.EudraCT: 2018–003219-23.ISCRTN: 41639809 (registered 16/04/2019).ClinicalTrials.gov Identifier: NCT04226248Protocol at time of publicationVersion 7.0, 20th January 2021.
Highlights
Falls are a common complication of Parkinson’s disease
The CHolinesterase Inhibitors to Prevent Falls in Parkinson’s Disease (CHIEF-Parkinson’s disease (PD)) trial will compare the fall rates of people with PD treated for 12 months with either transdermal rivastigmine or matched placebo
Sample size A total of 480 participants with primary outcome data (240 per group) will allow a 25% difference in geometric mean fall rate between the two treatment groups to be detected with 90% power at the two-sided 5% significance level. We previously demonstrated this to be the minimum clinically important difference (MCID) for a falls intervention in Parkinson’s using a Delphi approach [51]
Summary
Falls are a common complication of Parkinson’s disease. There is a need for new therapeutic options to target this debilitating aspect of the disease. Potential benefits of using cholinesterase inhibitors were shown during a single centre phase 2 trial. The aim of this trial is to evaluate the effectiveness of a cholinesterase inhibitor on fall rate in people with idiopathic Parkinson’s disease. Prospective studies report that around 61% of people with PD have at least one fall in a year and 39% fall recurrently [1]. Falls can cause injury [6], hospitalisation [7] and fear of further falling [8]. This in turn contributes to social isolation, restricted activity, loss of independence and carer burden [9]. Targeting falls has been identified as a top research priority by people living with Parkinson’s [10]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
