CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease)
NCT ID: NCT04226248
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2020-01-02
2025-07-24
Brief Summary
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Cholinesterase inhibitor (ChEis) are drugs that are currently used to treat people with memory problems in Parkinson's. The effect of these drugs on falls in Parkinson's has been tested to show that treatment has the potential to almost halve the number of falls.
This trial aims to definitively determine whether cholinesterase inhibitors (ChEi), can prevent falls in Parkinson's and whether this treatment is cost effective. 600 participants with Parkinson's disease will be enrolled from hospitals throughout the UK. Participants will be randomly assigned to either receive the drug (ChEi) via a patch or receive a placebo (dummy) treatment via a patch.
Neither the researchers nor the participants will know which group they are in. Participants will take the medication for 12 months and record any falls that they experience in diaries. If successful, this treatment in Parkinson's disease, would tackle one of the most disabling complications of the disease and positive findings will provide robust evidence to change clinical practice.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Active (Rivastigmine)
Rivastigmine Transdermal Patches
Rivastigmine Transdermal System
Rivastigmine Trandermal Patches applied once a day for up to 12 months
Placebo
Placebo Matched Transdermal Patches
Placebo Transdermal System
Placebo Trandermal Patches applied once a day for up to 12 months
Interventions
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Rivastigmine Transdermal System
Rivastigmine Trandermal Patches applied once a day for up to 12 months
Placebo Transdermal System
Placebo Trandermal Patches applied once a day for up to 12 months
Eligibility Criteria
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Inclusion Criteria
* Modified Hoehn and Yahr stage 1-4 disease as determined at baseline visit.
* Have experienced a fall in the previous year.
* Able to walk ≥10m without aids or assistance.
* 18+ years of age.
Exclusion Criteria
* Hypersensitivity to rivastigmine
* Dementia diagnosed according to MDS criteria (6).
* Inability to attend or comply with treatment or follow-up scheduling.
* Non-English-speaking patients (cognitive tests performed in English).
* Falling ≥4x per day.
* Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential.
* Pregnancy and/or breastfeeding
18 Years
ALL
No
Sponsors
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Royal United Hospitals Bath NHS Foundation Trust
OTHER
University of Bristol
OTHER
Responsible Party
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Principal Investigators
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Emily Henderson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bristol
Locations
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Barking, Havering and Redbridge University Hospitals NHS trust
Romford, Accepted, United Kingdom
Manchester University NHS Foundation Trust
Manchester, England, United Kingdom
Betsi Cadwaladr University Health Board
Bangor, Gwynedd, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Lothian Health Board NHS
Edinburgh, Scotland, United Kingdom
NHS Forth Valley
Larbert, Scotland, United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Bath, Somerset, United Kingdom
NHS Grampian
Aberdeen, , United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, , United Kingdom
University Hospitals Dorset NHS Foundation Trust
Bournemouth, , United Kingdom
Princess of Wales Hospital (Cwm Taf Morgannwg University Health Board)
Bridgend, , United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, , United Kingdom
North Bristol NHS Trust
Bristol, , United Kingdom
Pennine Acute Hospitals NHS Trust
Bury, , United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, , United Kingdom
NHS Tayside
Dundee, , United Kingdom
Gateshead Health NHS Foundation Trust
Gateshead, , United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
University Hospitals of Leicester NHS Foundation Trust
Leicester, , United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
Northumbria Healthcare NHS Foundation Trust
Newcastle, , United Kingdom
Newcastle Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Aneurin Bevan University Health Board
Newport, , United Kingdom
Oxford University Hospitals
Oxford, , United Kingdom
North West Anglia NHS Foundation Trust
Peterborough, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, , United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
North Tees and Hartlepool Hospitals NHS Foundation Trust
Stockton-on-Tees, , United Kingdom
Somerset NHS Foundation Trust
Taunton, , United Kingdom
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan, , United Kingdom
Betsi Cadwaladr University Health Board
Wrexham, , United Kingdom
Yeovil District Hospital
Yeovil, , United Kingdom
Countries
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References
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Neumann S, Taylor J, Bamford A, Metcalfe C, Gaunt DM, Whone A, Steeds D, Emmett SR, Hollingworth W, Ben-Shlomo Y, Henderson EJ. 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. BMC Neurol. 2021 Oct 29;21(1):422. doi: 10.1186/s12883-021-02430-2.
Other Identifiers
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Study 2018-2030
Identifier Type: -
Identifier Source: org_study_id
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