Category: Parkinson’s Disease: Clinical Trials
Objective: This abstract provides an overview of the progress of the CHIEF-PD trial.
Background: Falls are a common and debilitating consequence of Parkinson’s disease (PD). Falls are associated with significant morbidity and mortality including soft tissue injuries and fractures, hospital admissions as well as fear of falling. Cholinesterase inhibitors are established for the treatment of PD dementia and phase II trials have established the potential efficacy in fall prevention in PD. Further evidence is required to establish the clinical and cost-effectiveness.
Method: CHolinesterase Inhibitors to prEvent Falls in Parkinson’s Disease (CHIEF-PD) is a National Institute of Health Research funded, phase III, double blind randomised controlled trial of rivastigmine versus placebo for the prevention of falls in idiopathic Parkinson’s disease (PD). The trial will recruit 600 patients with PD across sites in the UK. Participants are eligible if they have iPD, have fallen in the year prior to enrolment, can walk 10m unaided and do not have dementia and are not using ChEis. Participants are enroled for one year and are prescribed transdermal rivastigmine (or matched placebo) 4.6mg for one month, 9.5mg for five months and 13.3mg for six months, as tolerated. The primary outcome is fall rate.
Results: The trial is recruiting across 33 centers in the UK with sites having recruited between 0 and 56 patients. As of 28th February 2022, 229 participants had been enroled. 11 participants have withdrawn due to burden of participation (7), intercurrent health issues (1) death (1) and reasons unknown (2). Of the enroled participants, 31 have discontinued the active / placebo patches largely secondary to already described side effects. 23 Serious Adverse Events have been reported and 4 of these have been possibly, probably or definitely related to the active / placebo patches.
Conclusion: The CHIEF-PD trial continues to recruit participants with iPD who have experienced a fall for randomisation to rivastigmine or matched placebo transdermal patches. The trial is recruiting well across multiple centres and the retention of participants remains above that predicted. The results of the CHIEF-PD trial will provide definitive evidence as to the clinical and cost-effectiveness for cholinesterase inhibitors for fall prevention in PD.
References: The CHIEF-PD trial continues to recruit participants with iPD who have experienced a fall for randomisation to rivastigmine or matched placebo transdermal patches. The trial is recruiting well across multiple centres and the retention of participants remains above that predicted. The results of the CHIEF-PD trial will provide definitive evidence as to the clinical and cost-effectiveness for cholinesterase inhibitors for fall prevention in PD.
To cite this abstract in AMA style:A. Bamford, S. Neumann, J. Taylor, G. Young, S. Emmett, W. Hollingworth, A. Whone, D. Steeds, C. Metcalfe, Y. Ben-Shlomo, E. Henderson. Progress of the UK Cholinesterase inhibitor to prevent falls in Parkinson’s disease (CHIEF-PD) trial [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/progress-of-the-uk-cholinesterase-inhibitor-to-prevent-falls-in-parkinsons-disease-chief-pd-trial/. Accessed March 4, 2024.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/progress-of-the-uk-cholinesterase-inhibitor-to-prevent-falls-in-parkinsons-disease-chief-pd-trial/