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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
600
Rivastigmine Trandermal Patches applied once a day for up to 12 months
Placebo Trandermal Patches applied once a day for up to 12 months
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
Fall rate
Fall rate measured using monthly diaries and telephone calls prospectively
Time frame: 12 months from the day the IMP is commenced
Parkinson's Disease (PD)
MDS-UPDRS total score in the practically defined 'ON' state and each individual subscale (1-4)
Time frame: 12 months
Freezing of gait
New Freezing of Gait Questionnaire (NFOGQ)
Time frame: 12 months
Frailty
Frailty assessed by the SHARE-FI
Time frame: 12 months
Physical performance
Measured by the Short physical performance battery (SPPB)
Time frame: 12 months
Freezing of Gait Assessment
Gait speed measured with Freezing of Gait (turn test)
Time frame: 12 months
Gait Assessment
Gait speed measured with and without dual task
Time frame: 12 months
Cognition
Montreal Cognitive Assessment (MoCA)
Time frame: 12 months
Depression
Geriatric Depression Scale (GDS)
Time frame: 12 months
Fear of falling
Iconographical Fall Efficacy Scale (ICON-FES)
Time frame: 12 months
Dysphagia
Swallowing Disturbance Questionnaire (SDQ)
Time frame: 12 months
Participant health related quality of life
EuroQoL 5D-5L health status questionnaire (EQ-5D-5L)
Time frame: 0,1,3,6 9 and 12 months
Capability of older people
ICEpop CAPability measure for Older people (ICECAP-O)
Time frame: 12 months
Mortality (all cause and PD-related)
Office of National Statistics (ONS) data
Time frame: 12 months
Cost effectiveness by NHS resource use
NHS Hospital Episode Statistics (HES) data
Time frame: 12 months
Apathy
Starkstein Apathy Scale
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 28 more locations