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EJ Henderson(1); G Young(2); D Pendry-Brazier(1), M Smith(1), K Lloyd(1), C Metcalfe(2), W Hollingworth(3); Y Ben-Shlomo(1) on behalf of the CHIEF-PD trial group

1. Ageing and Movement Research Group, Population Health Sciences, Bristol Medical School, University of Bristol, UK. 2. Bristol Trials Unit. University of Bristol, UK 3. Health Economics, Population Health Sciences, University of Bristol, UK.

SP - Parkinson's Disease

Clinical Trials

Abstract

Introduction. Falls are a common complication of Parkinson’s disease, driven in part by an underlying cholinergic deficit that contributes to gait and cognitive impairment. Phase 2 studies have established that amelioration of this deficit using cholinesterase inhibitors may reduce falls.

Methods. CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease) is a phase 3 randomised, double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson's disease that recruited from NHS sites. Relationships between the Principal Investigators’ specialty and the participants baseline characteristics were evaluated using linear, logistic and ordinal logistic regression. Cognitive impairment was defined as MoCA ≤26, while falls in the prior 12 months were separated into ordinal quartiles (1-2, 3-5, 6-12, 13+).

Results. Recruitment to CHIEF-PD commenced in January 2020 and completed in April 2023. Recruitment increased up until the start of the pandemic and thereafter there were 2 peaks. Potential participants were identified through clinic lists, databases, via national and local media and charities. 600 participants were enrolled across 38 sites. Sites enrolled between 1 and 74 participants, each. The median recruitment rate was 19 participants per month (IQR 6-27). 14 (37%) sites had Principal Investigators that were neurologists and 24 (63%) sites had PIs that were geriatricians. Most participants (76%) were over the age of 65 years. Compared with neurologists, geriatricians recruited older patients (difference in means 2.08 (95% CI 0.68, 3.48); p=0.004), with similar levels of cognitive impairment (OR 1.20 (95% CI 0.85, 1.69); p=0.293) and a lower fall rate (OR 0.46 (95% CI 0.34, 0.62); p<.001) at baseline.

Conclusion. Recruitment of older participants to a clinical trial an investigational medicinal product (ctimp) throughout the covid-19 pandemic across 38 uk centres was feasible using multiple strategies. characteristics varied according sub-speciality principal investigator site.