Drug trial seeks participants with Lewy body dementia
A drug trial aimed at treating memory and thinking problems in people with Lewy body dementia is recruiting participants through Join Dementia Research.
The COmBining memantine And cholinesterase inhibitors in Lewy body dementia Treatment (COBALT) trial is looking at whether giving an Alzheimer’s drug to people with Lewy body dementia can help improve their symptoms.
Slowing down memory loss
Researchers on the COBALT trial want to find out if memantine can improve brain health for people with Lewy body dementia who are already taking cholinesterase inhibitors.
Cholinesterase inhibitors – such as donepezil, rivastigmine and galantamine – can help improve memory function by restoring acetylcholine; a brain chemical involved in memory and learning. They are often prescribed to help improve hallucinations, confusion and sleepiness.
Memantine is a prescription drug, used alongside a cholinesterase inhibitor, to treat moderate to severe memory loss in people with Alzheimer’s disease. It works by blocking a specific receptor in the brain called the N-methyl-D-aspartate, which is believed to disrupt communication between brain cells, and causes problems with memory.
So far, there have been no large-scale definitive trials to show whether memantine – either on its own or with a cholinesterase inhibitor – is an effective treatment for Lewy body dementia.
The trial is funded and supported by the National Institute for Health and Care Research (NIHR) and is being led by Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust.
About Lewy body dementia
Accounting for 10 to 15 percent of dementia cases in the UK, Lewy body is the second most common form of dementia.
It is caused by a buildup of abnormal proteins in the brain which form Lewy bodies. Symptoms include hallucinations, memory problems, difficulty sleeping, unsteadiness and falls.
Very little is known about the condition, what causes it and how to treat it. It is hoped that this trial will help identify a medication that can be used to slow the progression of the disease.
The trial
The COBALT trial is seeking 300 participants aged 55 and over with a diagnosis of Lewy body dementia and taking a cholinesterase inhibitor. Lewy body dementia refers to people with dementia with Lewy bodies and people with Parkinson’s disease dementia, as both share similar symptoms. People with either diagnosis can take part in this study.
Participants and their carers are first invited to visit a hospital site or seen in their own home to check if they are eligible before being invited to take part in the trial.
They are then randomly allocated either memantine or a placebo, so that the symptoms of participants on the study drug can be compared to those who are not. Neither the researchers nor participants are told whether they are getting the study drug or a placebo, to avoid bias. The medication is taken daily by the patient at home in the form of a pill.
The researchers will have follow-up phone calls with participants after 3, 8, 14 and 38 weeks, with a face-to-face hospital or home visit after 24 and 52 weeks, to monitor their symptoms.
After 56 weeks, the trial will be completed and any changes in symptoms are recorded. Participants are also invited to an optional follow-up appointment after 2 years to assess whether there are any long-term changes in symptoms.
Where can I take part in the trial?
The COBALT trial is currently recruiting participants in the following regions across England and Scotland:
- Bristol
- Cambridgeshire
- Cornwall
- County Durham
- Devon
- Edinburgh
- Fife
- Hampshire
- Kent
- Norfolk
- Nottinghamshire
- Oxfordshire
- Greater London
- Suffolk
- Surrey
- Sussex
- Yorkshire
It is also being set up in further regions and will be recruiting participants until September 2024.
Other Lewy body dementia studies recruiting participants through Join Dementia Research include brain scans, blood tests and memory, cognitive and neurological tests to help researchers understand the condition better.
To find out if you are eligible to take part in these or another dementia study, sign in to your Join Dementia Research account or, if you are not already registered, sign up today.