NCT04226248CompletedPhase 3
CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease)
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.
Source: ClinicalTrials.gov · Last updated 29 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (actual)
- First submitted
- 5 Dec 2019
- Start date
- 2 Jan 2020
- Primary completion date
- 2 May 2024
- Lead sponsor
- University of Bristol
- Diseases
- Parkinson disease
- NCT number
- NCT04226248
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 600
- From 2 Jan 2020 to the primary completion date, 2 May 2024
- 38 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ChEi use in 12 months prior to enrolment.
Other illness
- Hypersensitivity to rivastigmine
- Dementia diagnosed according to MDS criteria (6).
Other
- 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
Who the study is looking for
- 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.
- 18+ years of age.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NHS Grampian Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Unknown status |
| Betsi Cadwaladr University Health Board Coordinator of this site? Confirm its status | Bangor | United Kingdom | Unknown status |
| Barnsley Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Barnsley | United Kingdom | Unknown status |
| Royal United Hospitals Bath NHS Foundation Trust Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
| University Hospitals Dorset NHS Foundation Trust Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| Princess of Wales Hospital (Cwm Taf Morgannwg University Health Board) Coordinator of this site? Confirm its status | Bridgend | United Kingdom | Unknown status |
| North Bristol NHS Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| University Hospitals Bristol and Weston NHS Foundation Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Pennine Acute Hospitals NHS Trust Coordinator of this site? Confirm its status | Bury | United Kingdom | Unknown status |
| University Hospitals of Derby and Burton NHS Foundation Trust Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
| NHS Tayside Coordinator of this site? Confirm its status | Dundee | United Kingdom | Unknown status |
| Lothian Health Board NHS Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Gateshead Health NHS Foundation Trust Coordinator of this site? Confirm its status | Gateshead | United Kingdom | Unknown status |
| Gloucestershire Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Gloucester | United Kingdom | Unknown status |
| NHS Forth Valley Coordinator of this site? Confirm its status | Larbert | United Kingdom | Unknown status |
| Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| University Hospitals of Leicester NHS Foundation Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| The Walton Centre NHS Foundation Trust Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| South Tees Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Unknown status |
| Newcastle Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Northumbria Healthcare NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Aneurin Bevan University Health Board Coordinator of this site? Confirm its status | Newport | United Kingdom | Unknown status |
| Norfolk and Norwich University Hospital Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| Oxford University Hospitals Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| North West Anglia NHS Foundation Trust Coordinator of this site? Confirm its status | Peterborough | United Kingdom | Unknown status |
| University Hospitals Plymouth NHS Trust Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Lancashire Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Preston | United Kingdom | Unknown status |
| Royal Berkshire NHS Foundation Trust Coordinator of this site? Confirm its status | Reading | United Kingdom | Unknown status |
| Barking, Havering and Redbridge University Hospitals NHS trust Coordinator of this site? Confirm its status | Romford | United Kingdom | Unknown status |
| Salford Royal NHS Foundation Trust Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| North Tees and Hartlepool Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Stockton-on-Tees | United Kingdom | Unknown status |
| Somerset NHS Foundation Trust Coordinator of this site? Confirm its status | Taunton | United Kingdom | Unknown status |
| Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Wigan | United Kingdom | Unknown status |
| Betsi Cadwaladr University Health Board Coordinator of this site? Confirm its status | Wrexham | United Kingdom | Unknown status |
| Yeovil District Hospital Coordinator of this site? Confirm its status | Yeovil | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.