CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease)
CHIEF-PD
CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease: A Phase 3 Randomised, Double-blind Placebo-controlled Trial of Rivastigmine to Prevent Falls in Parkinson's Disease.
1 other identifier
interventional
600
1 country
38
Brief Summary
Parkinson's disease is a common condition particularly affecting older people. Falls are a very frequent complication of the disease affecting 60% of people with Parkinson's every year. As the population ages, the number of people living with Parkinson's disease and the occurrence of complications will increase. The loss of the chemical dopamine in the brain causes walking in Parkinson's to become slower, unsteady and irregular. People with the condition are therefore at a very high risk of falling. To some extent, people can compensate for these changes by paying more attention to their walking. However, Parkinson's also diminishes memory and thinking ability. This decreases people's ability to pay attention to their walking, especially when doing something at the same time. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 parkinson-disease
Started Jan 2020
Longer than P75 for phase_3 parkinson-disease
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2019
CompletedStudy Start
First participant enrolled
January 2, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2025
CompletedSeptember 29, 2025
August 1, 2024
4.3 years
December 5, 2019
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fall rate
Fall rate measured using monthly diaries and telephone calls prospectively
12 months from the day the IMP is commenced
Secondary Outcomes (15)
Parkinson's Disease (PD)
12 months
Freezing of gait
12 months
Frailty
12 months
Physical performance
12 months
Freezing of Gait Assessment
12 months
- +10 more secondary outcomes
Study Arms (2)
Active (Rivastigmine)
ACTIVE COMPARATORRivastigmine Transdermal Patches
Placebo
PLACEBO COMPARATORPlacebo Matched Transdermal Patches
Interventions
Rivastigmine Trandermal Patches applied once a day for up to 12 months
Placebo Trandermal Patches applied once a day for up to 12 months
Eligibility Criteria
You may qualify if:
- Diagnosis of idiopathic Parkinson's disease.
- 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.
- + years of age.
You may not qualify if:
- Previous ChEi use in 12 months prior to enrolment.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Barking, Havering and Redbridge University Hospitals NHS trust
Romford, Accepted, BS8 1NU, United Kingdom
Manchester University NHS Foundation Trust
Manchester, England, M13 9WL, United Kingdom
Betsi Cadwaladr University Health Board
Bangor, Gwynedd, LL57 2PW, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY, United Kingdom
Lothian Health Board NHS
Edinburgh, Scotland, EH1 3EG, United Kingdom
NHS Forth Valley
Larbert, Scotland, FK5 4WR, United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Bath, Somerset, BA1 3NG, United Kingdom
NHS Grampian
Aberdeen, AB15 6RE, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, S75 2EP, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Bournemouth, BH23 2JX, United Kingdom
Princess of Wales Hospital (Cwm Taf Morgannwg University Health Board)
Bridgend, CF31 1RQ, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, BS1 3NU, United Kingdom
North Bristol NHS Trust
Bristol, BS10 5NB, United Kingdom
Pennine Acute Hospitals NHS Trust
Bury, BL9 7TD, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, DE22 3NE, United Kingdom
NHS Tayside
Dundee, DD2 1UB, United Kingdom
Gateshead Health NHS Foundation Trust
Gateshead, NE9 6SX, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, GL1 3NN, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS2 3AX, United Kingdom
University Hospitals of Leicester NHS Foundation Trust
Leicester, LE1 5WW, United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ, United Kingdom
Imperial College Healthcare NHS Trust
London, W6 8RF, United Kingdom
University College London Hospitals NHS Foundation Trust
London, WC1N 3BG, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BS, United Kingdom
Northumbria Healthcare NHS Foundation Trust
Newcastle, NE27 0QJ, United Kingdom
Newcastle Hospitals NHS Foundation Trust
Newcastle, NE7 7DN, United Kingdom
Aneurin Bevan University Health Board
Newport, NP18 3XQ, United Kingdom
Oxford University Hospitals
Oxford, OX3 9DU, United Kingdom
North West Anglia NHS Foundation Trust
Peterborough, PE3 9GZ, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, PL6 5FP, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, PR2 9HT, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN, United Kingdom
Salford Royal NHS Foundation Trust
Salford, MA6 8HD, United Kingdom
North Tees and Hartlepool Hospitals NHS Foundation Trust
Stockton-on-Tees, TS19 8PE, United Kingdom
Somerset NHS Foundation Trust
Taunton, TA1 5DA, United Kingdom
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan, WN1 2NN, United Kingdom
Betsi Cadwaladr University Health Board
Wrexham, LL13 7YP, United Kingdom
Yeovil District Hospital
Yeovil, United Kingdom
Related Publications (1)
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.
PMID: 34715821DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Henderson, PhD
University of Bristol
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2019
First Posted
January 13, 2020
Study Start
January 2, 2020
Primary Completion
May 2, 2024
Study Completion
July 24, 2025
Last Updated
September 29, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share