CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease)
- Conditions
- Parkinson Disease
- Interventions
- Other: Placebo Transdermal System
- Registration Number
- NCT04226248
- Lead Sponsor
- University of Bristol
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active (Rivastigmine) Rivastigmine Transdermal System Rivastigmine Transdermal Patches Placebo Placebo Transdermal System Placebo Matched Transdermal Patches
- Primary Outcome Measures
Name Time Method Fall rate 12 months from the day the IMP is commenced Fall rate measured using monthly diaries and telephone calls prospectively
- Secondary Outcome Measures
Name Time Method Participant health related quality of life 0,1,3,6 9 and 12 months EuroQoL 5D-5L health status questionnaire (EQ-5D-5L)
Apathy 12 months Starkstein Apathy Scale
Gait Assessment 12 months Gait speed measured with and without dual task
Depression 12 months Geriatric Depression Scale (GDS)
Fear of falling 12 months Iconographical Fall Efficacy Scale (ICON-FES)
Freezing of gait 12 months New Freezing of Gait Questionnaire (NFOGQ)
Cognition 12 months Montreal Cognitive Assessment (MoCA)
Parkinson's Disease (PD) 12 months MDS-UPDRS total score in the practically defined 'ON' state and each individual subscale (1-4)
Frailty 12 months Frailty assessed by the SHARE-FI
Freezing of Gait Assessment 12 months Gait speed measured with Freezing of Gait (turn test)
Capability of older people 12 months ICEpop CAPability measure for Older people (ICECAP-O)
Mortality (all cause and PD-related) 12 months Office of National Statistics (ONS) data
Cost effectiveness by NHS resource use 12 months NHS Hospital Episode Statistics (HES) data
Physical performance 12 months Measured by the Short physical performance battery (SPPB)
Dysphagia 12 months Swallowing Disturbance Questionnaire (SDQ)
Trial Locations
- Locations (37)
University Hospitals Plymouth NHS Trust
🇬🇧Plymouth, United Kingdom
NHS Forth Valley
🇬🇧Larbert, Scotland, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, Norfolk, United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
🇬🇧Bath, Somerset, United Kingdom
Manchester University NHS Foundation Trust
🇬🇧Manchester, England, United Kingdom
Somerset NHS Foundation Trust
🇬🇧Taunton, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS trust
🇬🇧Romford, Accepted, United Kingdom
Betsi Cadwaladr University Health Board
🇬🇧Wrexham, United Kingdom
Lothian Health Board NHS
🇬🇧Edinburgh, Scotland, 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
Gateshead Health NHS Foundation Trust
🇬🇧Gateshead, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
NHS Tayside
🇬🇧Dundee, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
🇬🇧Gloucester, 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
South Tees Hospitals NHS Foundation Trust
🇬🇧Middlesbrough, United Kingdom
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Aneurin Bevan University Health Board
🇬🇧Newport, United Kingdom
Newcastle Hospitals NHS Foundation Trust
🇬🇧Newcastle, United Kingdom
Oxford University Hospitals
🇬🇧Oxford, United Kingdom
North West Anglia NHS Foundation Trust
🇬🇧Peterborough, 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
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
🇬🇧Wigan, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, United Kingdom
Northumbria Healthcare NHS Foundation Trust
🇬🇧Newcastle, United Kingdom