Dementia is a condition that people often associate with memory problems, but it can also affect people in many other ways. Behavioural changes someone with dementia may experience can sometimes be just as challenging, both for the person living with dementia, as well as their carers or family members. Thanks to your support, we are now able to fund a new clinical trial to explore whether a cannabis-based treatment could help.
Agitation, a state of anxiety and disturbance, is one of the lesser known symptoms of Alzheimer’s disease, the most common cause of dementia. And although there are some medications, known as antipsychotics, which may be prescribed to help people with Alzheimer’s if they are experiencing severe agitation, previous research funded by Alzheimer’s Research UK has revealed serious potential side effects that have to be carefully weighed against their benefits.
Moves have now been made to reduce the use of these antipsychotic drugs in people with Alzheimer’s, and we need safer alternatives.
Why is Alzheimer’s Research UK funding this trial?
While Alzheimer’s Research UK continues to fund research into treatments that will slow or stop the diseases that cause dementia from damaging the brain, we must also invest in other ways to help improve the lives of those living with the disease. The includes way to address symptoms that can make life harder for people with dementia.
Around half of the 850,000 people with dementia in the UK will experience agitation as part of their condition and it can be a major reason why people with dementia move into full time care.
It has been over fifteen years since a new dementia medicine came to market and we need to explore every possible angle to find more ways to help. Your support means we are now able to fund a clinical trial at King’s College London to explore whether an existing medication could help to ease agitation experienced by people with Alzheimer’s disease.
What is the treatment we are testing?
The drug, which will be tested in this carefully controlled trial, is a cannabis-based medicine called Sativex®. The drug has already been found to be safe in people and has been approved for use in the treatment of muscle stiffness and tightness experienced by people with multiple sclerosis. However, Sativex® is not currently licensed in the UK for any other indication, including treatment of the symptoms of dementia. The trial will now test whether it’s feasible to treat agitation in people with Alzheimer’s disease with the drug.
In November 2018 the government moved cannabis-based products for medicinal from Schedule 1 to 2 – enabling their prescription by specialist clinicians. Sativex®, however, is a Schedule 4 drug given its regulatory approval by MHRA in 2010 and its established quality, safety and efficacy.
Sativex® is a peppermint-flavoured mouth spray that contains a 1:1 ratio of two key cannabinoids found in the cannabis plant – delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The plants are grown under a Home Office licence in the UK in highly controlled and secure conditions which, taken alongside high-tech manufacturing processes, ensures batch to batch consistency in each bottle.
There’s been a lot of attention given to cannabis-based medicine recently in the media, however Dr David Reynolds, Alzheimer’s Research UK’s Chief Scientific Officer, stressed that people should not take cannabis in an uncontrolled setting.
“There is no good evidence that using cannabis in an uncontrolled setting could benefit people living with dementia, and we know that the drug can involve risks including short-term memory and thinking problems, coordination difficulties and anxiety.”
So how do clinical trials like this work? And how much hope should we have?
Like any drug, we must wait to see the results from this carefully controlled trial before we can tell if it will be feasible for use in people with Alzheimer’s who have symptoms of agitation.
So how do clinical trials like this work? Well, this is a phase II clinical trial, so that means the treatment will be in a group of people actually affected by the disease.
The study team aim to recruit 60 volunteers with Alzheimer’s disease between 55 and 90 years old, who are living in care homes and are experiencing agitation or aggression. During the trial the researchers will carefully assess the symptoms of those taking the medication against those taking a dummy drug.
One of the key questions the trial will try to answer is whether it is practical to give someone with dementia a drug using a mouth spray, especially if those people’s symptoms mean they are experiencing some level of distress and discomfort. Researchers will also get an indication of whether it is safe and effective at reducing symptoms, although larger studies including a phase III trial will be needed to get firm evidence of this.
It’s critical that any drug is safe and practical to use
It’s critical that any drug is safe and practical to use. This means that going ahead with the larger studies will depend on whether the results of the phase II trial show that the drug is likely to be reasonably safe and useful in people with Alzheimer’s. This is only one of many reasons why approval of the drug for a new indication cannot be guaranteed at this stage.
We look forward to seeing the outcome of this pioneering research and hope this new trial brings us closer to breakthroughs that improve lives.
If you have any questions about the research we fund you can ring our Dementia Research Infoline on 0300 111 5 111.
To donate to fund dementia research and make vital breakthroughs possible visit https://donate.alzheimersresearchuk.org/