A Phase 3 interventional study of Rivastigmine Transdermal System and Placebo Transdermal System in Parkinson Disease, sponsored by University of Bristol. Completed at 38 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by University of Bristol · Phase 3, Interventional, and Prevention
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 600 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Bristol is the lead sponsor of 22 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rivastigmine Transdermal Patches
Drug: Rivastigmine Transdermal System
Placebo Matched Transdermal Patches
Other: Placebo Transdermal System
Rivastigmine Trandermal Patches applied once a day for up to 12 months
Placebo Trandermal Patches applied once a day for up to 12 months
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
Plan to share: No
Ran from Jan 2020 to primary completion in May 2024, 52 months.
Of 67 phase 3 interventional studies under Parkinson Disease, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's 52 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Bristol