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Prof John-Paul Taylor
+44 191 2081311
john-paul.taylor@ncl.ac.uk


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Be Part of Research - Trial Details - Predicting response to treatment in early Lewy body disease
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Predicting response to treatment in early Lewy body disease

Recruiting

Open to: All Genders

Age: Adult

Newcastle

Medical Conditions

Dementia, Lewy body disease

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Lewy body dementia (LBD) is a condition that effects thinking abilities and movement of affected individuals. Some people with LBD may benefit from treatment with a cholinesterase inhibitor, which affect a brain chemical system called the cholinergic system while others do not. The aim of this study is to develop a new test to identify which people with early stage Lewy Body Dementia (LBD) will respond best to treatments. A central feature of LBD is evidence of cholinergic loss, which contributes to symptoms like visual hallucinations, risk of falls, problems with walking and our ability to think, read and understand (cognition) the world around us.

One way to do this is to make use of electroencephalography (EEG). This is a method of recording brain signals using wires attached to a head cap; a completely pain free procedure, which allows the recording of changes in brainwaves. These changes might indicate whether someone could respond to a cholinergic treatment. We will give people with early stage LBD a short course of treatment with an established cholinergic drug called donepezil. Donepezil is also known as Aricept which you may be familiar with as a treatment for Alzheimer’s disease and LBD. We will explore if there are changes in brainwaves in participants after being given donepezil. Participants will either get the real drug or a pretend (placebo) drug. We will see whether we can predict any improvements in thinking abilities based on visible changes in the EEG brainwaves.

Another way of putting it is that by identifying brainwave patterns we can attempt to predict which participant will benefit most from the study medication.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

28 Feb 2020 31 Oct 2025

Participants will be randomly assigned (like flipping a coin) to receive either donepezil or a placebo for a certain period of time (with the exception of the healthy volunteers) followed by a period when no drug would be given before switching over to the other treatment group. Both donepezil and placebo will look exactly the same, hence both participants and researchers will not know at any point during the study whether they are receiving active treatment or placebo.
The medication being given in this study is normally used to treat certain conditions causing memory loss, it can slow down the progression of these conditions and cause memory to improve in some individuals. There are side effects that can happen with the treatment although most people tolerate this well.

We will also ask people to undergo a number of other tests including for example assessment of thinking abilities and memory. These assessments come under the umbrella terms of neurocognitive and neuropsychiatric testing and include drawing complex figures, reading aloud and problem solving but there are also questions related to personal feelings, mood and quality of life and some of these are addressed to the informal carer (like a spouse or close relative). It is essential for this study that we also conduct examination of the brain internally and we do this using two types of scanning, magnetic resonance imaging (MRI) and positron emission topography (PET). An MRI scan is used because it provides detailed structural images of the brain and we use PET scans to see the functioning of the brain. The PET scan uses a special dye containing radioactive tracers which will be delivered intravenously and will then highlight the specific areas of interest within the brain. A further element of this study protocol is the delivery of transcranial magnetic stimulation (TMS). This involves stimulation of the brain cells using a magnetic coil and it is also a completely pain free process. Its purpose is to inform us further of the cholinergic function of participants. A common symptom of LBD is a change in the way a person walks (gait). Participants will be assessed at the Gait lab and will undertake two tests walking around a short circuit and then repeating this while doing a task. These tests will be recorded and analysed. Following these assessments participants will then return home wearing a body sensor for a period of 7 days and this will record their levels of activity, gait, sleep and functional performance.

This will provide us with a very rich data set which may support the use of EEG as an easy to use way of identifying cholinergic function, permitting a more precise treatment approach for patients, which is currently lacking in this disease group.


We aim to enrol 60 participants with LBD and 16 healthy volunteers.

You can take part if:



You may not be able to take part if:


1. History of significant cerebrovascular disease2. Presence of major cerebrovascular disease on brain imaging (severe leukoaraiosis or infarcts in strategic areas)3. Other neurological diseases which may cause cognitive impairment e.g. a diagnosis of progressive supranuclear palsy, multiple system atrophy, or corticobasal degeneration, according to accepted diagnostic criteria4. Presence of major depression5. Physical co-morbidities including: history of severe gastrointestinal ulceration, severe asthma or obstructive pulmonary disease; systolic hypotension (< 90 mmHg); bradycardia (< 50 beats per minute); sick sinus syndrome; atrial or atrioventricular conduction block; QT interval prolongation (> = 450 ms)6. Use of cognitive enhancing medications (e.g. cholinesterase inhibitors, memantine)7. High dose benzodiazepines, antipsychotics or anticonvulsants8. Use of anticholinergics with significant central effects e.g. oxybutynin 9. Contraindications to MR scanning (e.g. inability to lie flat for 30 minutes, claustrophobia, inability to tolerate a previous similar procedure, MR incompatible pacemaker)10. Severe kidney disease11. History of deep brain stimulation12. Unstable and/or significant medical comorbidity likely to interfere with compliance13. Significant functional deficits likely to interfere with compliance14. Severe parkinsonism (Hoehn and Yahr stage IV or above)15. Hypersensitivity to donepezil or piperidine derivatives


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Freeman Hospital
    Newcastle Upon Tyne Hospital Trust Freeman Road High Heaton
    Newcastle
    NE7 7DN

Medication: The cholinesterase inhibitor Donepezil is normally used to treat certain conditions causing memory loss, it can slow down the progression of these conditions and cause memory to improve in some individuals. The possible adverse effects of donepezil are well established and include: Common or very common(up to 1 in 10): Aggression; agitation; decreased appetite; common cold; diarrhoea; dizziness; fatigue; gastrointestinal disorders; hallucination; headache; injury; muscle cramps; nausea; pain; skin reactions; sleep disorders; syncope; urinary incontinence; vomiting Uncommon (less than 1 in 100) Bradycardia; gastrointestinal haemorrhage; hypersalivation; seizure Rare or very rare (less than 1 in 1000) Cardiac conduction disorders; extrapyramidal symptoms; hepatic disorders; neuroleptic malignant syndrome; rhabdomyolysis Most people tolerate donepezil well.
Neurocognitive and neuropsychiatry tests: There is no adverse effect from these assessments. Doing these tests will take time for the participants and their care-givers. However, from our prior experience, many participants value the social interaction and engagement that being involved in a research study brings. We will make it more convenient for the participants by conducting a home visit so that this can be done in the comfort of their homes and paced according to their ability/availability. In a similar study using similar test battery, it took approximately two hours for the tests to be completed. These tests were well received by the participants and their care-givers.
ontraindications for MRI are verified, and repeated immediately prior to the MR scan. There are no known risks associated with the MR scan, and the scan is not painful. The only discomfort some people feel is claustrophobia whilst in the scanner and that they will need to lie still for the period of the scan (up to 40 minutes).
200 participants).
150 participants).
We will alleviate anxiety from undergoing these procedures by explaining to the participants and addressing any concerns they may have. Our previous experience indicates that dementia participants and their carer or relative derive benefit from the additional contact with research staff, and from the sense of helping with research into these illnesses.

Prof John-Paul Taylor
+44 191 2081311
john-paul.taylor@ncl.ac.uk



The study is sponsored by Newcastle upon Tyne Hospitals NHS Foundation Trust and funded by NIHR Newcastle Biomedical Research Centre.



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Read full details for Trial ID: ISRCTN49497250

Or CPMS 43617

Last updated 06 June 2025

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