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01-12-2021 | Parkinson's Disease | Study protocol

Cholinesterase inhibitor to prevent falls in Parkinson’s disease (CHIEF-PD) trial: a phase 3 randomised, double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease

Authors: S. Neumann, J. Taylor, A. Bamford, C. Metcalfe, D. M. Gaunt, A. Whone, D. Steeds, S. R. Emmett, W. Hollingworth, Y. Ben-Shlomo, E. J. Henderson

Published in: BMC Neurology | Issue 1/2021

Abstract

Background

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. 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.

Methods

This 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.

Discussion

This 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 registration

REC reference: 19/SW/0043.

EudraCT: 2018–003219-23.

ISCRTN: 41639809 (registered 16/04/2019).

ClinicalTrials.gov Identifier: NCT04226248

Protocol at time of publication

Version 7.0, 20th January 2021.

Available only for authorised users

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Title: Cholinesterase inhibitor to prevent falls in Parkinson’s disease (CHIEF-PD) trial: a phase 3 randomised, double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease
Authors: S. Neumann
J. Taylor
A. Bamford
C. Metcalfe
D. M. Gaunt
A. Whone
D. Steeds
S. R. Emmett
W. Hollingworth
Y. Ben-Shlomo
E. J. Henderson
Publication date: 01-12-2021
Publisher: BioMed Central
Keyword: Parkinson's Disease
Published in: BMC Neurology / Issue 1/2021
Electronic ISSN: 1471-2377
DOI: https://doi.org/10.1186/s12883-021-02430-2

2024 ASCO Annual Meeting

Springer Medicine

Cholinesterase inhibitor to prevent falls in Parkinson’s disease (CHIEF-PD) trial: a phase 3 randomised, double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease

Abstract

Background

Methods

Discussion

Trial registration

Protocol at time of publication

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Protocol at time of publication

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