CompletedPhase IIIInterventional

A trial of rivastigmine to prevent falls in Parkinson's

Falls are very common in Parkinson’s disease, affecting about six in ten people each year. The condition causes walking to become slower and less steady. It can also make it harder to concentrate on your steps, raising the risk of tripping or losing balance. This UK-wide clinical trial, called CHIEF-PD, is testing whether a medicine called rivastigmine can help. Rivastigmine is already widely used for memory problems. Earlier research suggests it might also sharpen attention enough to almost halve falls in people with Parkinson’s. The trial is enrolling 600 adults with Parkinson’s across the UK. Participants will wear a skin patch every day for 12 months. Half will receive the active medication and half will receive a dummy (placebo) patch. Everyone will keep a simple diary to track any falls and help researchers see if the treatment works.

At a glance

Status

Completed

Phase

Phase III

Sponsor

University of Bristol

Enrolment target

600

Start

02 Sep 2019

Estimated completion

30 Apr 2023

Parkinson's Disease

What is this study about?

Parkinson’s disease is a common condition that affects how the brain controls movement. As time goes on, the loss of a brain chemical called dopamine makes walking slower, stiffer, and less steady. Many people try to stay upright by concentrating hard on every step. However, Parkinson's can also affect thinking speed and memory. This makes it difficult to stay focused on walking, especially when talking, carrying something, or navigating everyday obstacles. Because of this, around 60% of people with Parkinson’s experience a fall each year, which can lead to injury and loss of confidence.

Researchers want to see if a medication called rivastigmine can reduce these falls. Rivastigmine belongs to a group of medicines called cholinesterase inhibitors. Doctors already prescribe it safely to help with memory and attention problems. Scientists believe that by boosting brain chemicals that support concentration, the drug may help people pay better attention to their balance and avoid tripping.

The CHIEF-PD trial aims to find out for certain whether using a daily rivastigmine patch reduces falls and provides good value for the NHS. By taking part, participants help doctors learn whether this existing treatment can become a simple, standard way to keep people with Parkinson's safer on their feet.

Key takeaways

Tests whether a daily rivastigmine skin patch reduces falls in Parkinson's disease.
Open to adults with Parkinson's who have fallen at least once in the last year.
Involves 600 participants across UK hospital clinics over a 12-month period.
Half of participants receive the medicine patch and half receive a dummy patch.
Taking part is voluntary and you may withdraw at any time.

Who may be eligible?

This study is open to adults aged 18 and older who have been diagnosed with Parkinson's disease. To qualify, you must have had at least one fall in the past year, but not fall four or more times every day. You also need to be able to walk at least 10 metres on your own without walking aids or help from another person.

You cannot join if you have used rivastigmine or a similar memory medicine in the past 12 months, or if you are allergic to it. The study is also not suitable for people diagnosed with dementia, or those who cannot attend clinic visits or complete the study tasks.

Because study memory tests are given in English, participants need to speak English. Women who are pregnant, breastfeeding, or who could become pregnant and do not wish to use reliable contraception are also unable to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 18 years old or older and have a diagnosis of Parkinson's disease.
I have fallen at least once in the past 12 months.
I do not fall four or more times every day.
I can walk at least 10 metres without walking sticks, frames, or personal help.
I have not taken rivastigmine or similar memory medicines in the past year.
I have not been diagnosed with dementia.

Answer every question to see your result.

What does participation involve?

If you join the trial, you will take part for roughly 12 months. You will be placed by chance (like flipping a coin) into one of two groups. One group will use skin patches containing rivastigmine, and the other will use matching dummy (placebo) patches. Neither you nor your study doctors will know which patch you are receiving, ensuring the results are fair.

You will apply a new patch to your skin every day. During the year, you will attend regular hospital appointments for check-ups, balance tests, and memory tasks. Because these tests are thorough, they can sometimes feel tiring. You will also be asked to keep a daily diary to record whether you have had any trips or falls. The research team will stay in touch to support you and check how you are feeling throughout the study.

Potential risks and benefits

If you receive the active medicine, your balance may improve and your risk of falling may drop, though this cannot be guaranteed. Your participation will also provide vital information to help treat Parkinson's disease in the future. Rivastigmine can cause side effects like mild sickness, loss of appetite, or skin irritation under the patch, although these often settle as your body gets used to the dose. The study assessments can also feel tiring. Taking part is completely voluntary, and you are free to leave the trial at any time without your regular NHS care being affected.

Locations (33)

Royal United Hospitals Bath NHS Foundation Trust
City only
Bath, England
Salford Royal NHS Foundation Trust
City only
Salford, England
Northern Care Alliance
City only
Manchester, England
Royal Cornwall Hospitals NHS Trust
City only
Truro, England
NHS Lothian
Approximate
Edinburgh, Scotland
Derby Teaching Hospitals NHS Foundation Trust
Unverified
Derby, England
Plymouth Hospitals NHS Trust
Unverified
Plymouth, England
Imperial College Healthcare NHS Trust
Unverified
London, England
Yeovil District Hospital NHS Foundation Trust
Unverified
Yeovil, England
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Unverified
Newcastle-upon-Tyne, England
Taunton And Somerset NHS Foundation Trust
Unverified
Taunton, England
Cambridge University Hospitals NHS Foundation Trust
Unverified
Cambridge, England

Common questions

What is rivastigmine?

Rivastigmine is an approved medicine that boosts chemical signals in the brain linked to attention and memory. In this study, it is given as an everyday stick-on skin patch.

What is a placebo patch?

A placebo is a dummy patch that looks identical to the real medicine patch but contains no active drug. It helps scientists prove whether any changes are truly caused by the medicine.

Will I know if I am getting the real medicine?

No. To keep the findings unbiased, neither you nor your doctors will know which patch you are using until the study is finished.

Do I have to stop taking my normal Parkinson's medications?

No. You will continue to take your prescribed Parkinson's medications as usual, unless your doctor advises otherwise.

Can I leave the trial early if I change my mind?

Yes. You can leave the study at any point without giving a reason, and it will not change the standard of your ongoing NHS treatment.

How to find out more

Emily Henderson

Chief-pd@bristol.ac.uk +44 (0)117 4283111 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.