Rivastigmine Transdermal System
DrugRivastigmine Trandermal Patches applied once a day for up to 12 months
NCT Number: NCT04226248
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Barking, Havering and Redbridge University Hospitals NHS trust, Romford, Accepted, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rivastigmine Trandermal Patches applied once a day for up to 12 months
Placebo Trandermal Patches applied once a day for up to 12 months
Time frame: 12 months from the day the IMP is commenced
Fall rate measured using monthly diaries and telephone calls prospectively
Time frame: 12 months
MDS-UPDRS total score in the practically defined 'ON' state and each individual subscale (1-4)
Time frame: 12 months
New Freezing of Gait Questionnaire (NFOGQ)
Time frame: 12 months
Frailty assessed by the SHARE-FI
Time frame: 12 months
Measured by the Short physical performance battery (SPPB)
Time frame: 12 months
Gait speed measured with Freezing of Gait (turn test)
Time frame: 12 months
Gait speed measured with and without dual task
Time frame: 12 months
Montreal Cognitive Assessment (MoCA)
Time frame: 12 months
Geriatric Depression Scale (GDS)
Time frame: 12 months
Iconographical Fall Efficacy Scale (ICON-FES)
Time frame: 12 months
Swallowing Disturbance Questionnaire (SDQ)
Time frame: 0,1,3,6 9 and 12 months
EuroQoL 5D-5L health status questionnaire (EQ-5D-5L)
Time frame: 12 months
ICEpop CAPability measure for Older people (ICECAP-O)
Time frame: 12 months
Office of National Statistics (ONS) data
Time frame: 12 months
NHS Hospital Episode Statistics (HES) data
Time frame: 12 months
Starkstein Apathy Scale
University of Bristol
Other
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.
Acronym: CHIEF-PD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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