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.
| Original language | English |
|---|---|
| Article number | 422 |
| Pages (from-to) | 422 |
| Journal | BMC Neurology |
| Volume | 21 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 29 Oct 2021 |
Bibliographical note
Funding Information:This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA 16/31/13). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UKCRC registered clinical trials unit which, as part of the Bristol Trials Centre, is in receipt of National Institute for Health Research CTU support funding. We are grateful to Dr. Gordon Duncan, Dr. Veronica Lyell and Associate Professor Camille Carroll for their valuable comments on the draft protocol. This study is sponsored by the University of Bristol who provide and oversight and governance for the running of the trial (https://www.bristol.ac.uk/red). They were not involved in the preparation of this manuscript nor the decision to submit for publication.
Funding Information:
EJH has received funding from the National Institute of Health Research, Parkinson’s UK, The Gatsby Foundation and The British Geriatrics Society and has received fees and / or travel support from Bial, Abbvie, Luye and Profile, Ever, and Kyowa Kirin.
Funding Information:
This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA 16/31/13). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Publisher Copyright:
© 2021, The Author(s).
Structured keywords
- Ageing and Movement Research Group
- CHIEFPD
- HEHP@Bristol
- BRTC
Keywords
- Cholinesterase Inhibitors/therapeutic use
- Double-Blind Method
- Gait Disorders, Neurologic
- Humans
- Parkinson Disease/complications
- Quality of Life
- Rivastigmine/therapeutic use