Objective: Preventing falls in people with Parkinson’s disease has the potential to reduce hospital admissions and improve quality of life by diminishing the significant morbidity associated with this complication. The Cholinesterase Inhibitor to prEvent Falls in Parkinson’s disease (CHIEF-PD) trial seeks to evaluate the effectiveness of rivastigmine, a cholinesterase inhibitor, in reducing fall rate in people with Parkinson’s.

Background: Falls are a common and debilitating complication of Parkinson’s disease. Cholinergic deficit has been shown to contribute to both gait and cognitive dysfunction seen in the condition. Previous small trials with a cholinesterase inhibitor suggest potential benefit [1]. It is hypothesised that ameliorating the cholinergic deficit will improve attention and/or gait stability and lead to a reduced rate of falls.

Method: This Phase III, multi-centre, blinded, randomised placebo-controlled trial will enrol 600 people with Hoehn & Yahr stage 1–4 idiopathic Parkinson’s disease who have fallen in the past year. Participants will be randomised to receiving either rivastigmine (active) or placebo transdermal patches administered for 12 months. Randomisation will be stratified by recruiting site using age, MoCA score and number of falls in past year as minimisation criteria. The primary outcome is the rate of falls measured prospectively over 12 months. Falls will be measured by monthly diaries and phone calls. Secondary outcome measures, collected at baseline and 12 months, include gait and balance measures, neuropsychiatric indices, fear of falling, MDS-UPDRS  and cost-effectiveness. Adverse events and compliance will be measured and reported.

Results: We anticipate that patients who are allocated the active treatment with rivastigmine will have a lower rate of falls over the 12 months and better gait and balance measures. We will explore the effect on neuropsychiatric indices, fear of falling and Parkinson’s symptoms measured by the MDS-UPDRS.

Conclusion: This Phase III, blinded, randomised, placebo-controlled trial will assess the clinical and cost effectiveness of rivastigmine in reducing the rate of falls in people with Parkinson’s disease. If successful this would offer a novel, acceptable and effective intervention to tackle a common and particularly debilitating complication of the disease.

References: [1] Henderson et al. 2016, the Lancet Neurology 15(3): 249-258

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