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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
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

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NHS Grampian
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AberdeenUnited KingdomUnknown status
Betsi Cadwaladr University Health Board
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BangorUnited KingdomUnknown status
Barnsley Hospital NHS Foundation Trust
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BarnsleyUnited KingdomUnknown status
Royal United Hospitals Bath NHS Foundation Trust
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BathUnited KingdomUnknown status
University Hospitals Dorset NHS Foundation Trust
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BournemouthUnited KingdomUnknown status
Princess of Wales Hospital (Cwm Taf Morgannwg University Health Board)
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BridgendUnited KingdomUnknown status
North Bristol NHS Trust
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BristolUnited KingdomUnknown status
University Hospitals Bristol and Weston NHS Foundation Trust
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BristolUnited KingdomUnknown status
Pennine Acute Hospitals NHS Trust
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BuryUnited KingdomUnknown status
University Hospitals of Derby and Burton NHS Foundation Trust
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DerbyUnited KingdomUnknown status
NHS Tayside
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DundeeUnited KingdomUnknown status
Lothian Health Board NHS
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EdinburghUnited KingdomUnknown status
Gateshead Health NHS Foundation Trust
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GatesheadUnited KingdomUnknown status
Gloucestershire Hospitals NHS Foundation Trust
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GloucesterUnited KingdomUnknown status
NHS Forth Valley
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LarbertUnited KingdomUnknown status
Leeds Teaching Hospitals NHS Trust
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LeedsUnited KingdomUnknown status
University Hospitals of Leicester NHS Foundation Trust
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LeicesterUnited KingdomUnknown status
The Walton Centre NHS Foundation Trust
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LiverpoolUnited KingdomUnknown status
Imperial College Healthcare NHS Trust
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LondonUnited KingdomUnknown status
University College London Hospitals NHS Foundation Trust
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LondonUnited KingdomUnknown status
Manchester University NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
South Tees Hospitals NHS Foundation Trust
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MiddlesbroughUnited KingdomUnknown status
Newcastle Hospitals NHS Foundation Trust
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NewcastleUnited KingdomUnknown status
Northumbria Healthcare NHS Foundation Trust
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NewcastleUnited KingdomUnknown status
Aneurin Bevan University Health Board
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NewportUnited KingdomUnknown status
Norfolk and Norwich University Hospital
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NorwichUnited KingdomUnknown status
Oxford University Hospitals
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OxfordUnited KingdomUnknown status
North West Anglia NHS Foundation Trust
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PeterboroughUnited KingdomUnknown status
University Hospitals Plymouth NHS Trust
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PlymouthUnited KingdomUnknown status
Lancashire Teaching Hospitals NHS Foundation Trust
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PrestonUnited KingdomUnknown status
Royal Berkshire NHS Foundation Trust
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ReadingUnited KingdomUnknown status
Barking, Havering and Redbridge University Hospitals NHS trust
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RomfordUnited KingdomUnknown status
Salford Royal NHS Foundation Trust
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SalfordUnited KingdomUnknown status
North Tees and Hartlepool Hospitals NHS Foundation Trust
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Stockton-on-TeesUnited KingdomUnknown status
Somerset NHS Foundation Trust
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TauntonUnited KingdomUnknown status
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
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WiganUnited KingdomUnknown status
Betsi Cadwaladr University Health Board
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WrexhamUnited KingdomUnknown status
Yeovil District Hospital
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YeovilUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.