Researchers in London are looking for volunteers living in the capital’s care homes to take part in a new trial for people with Alzheimer’s disease. The phase II trial will explore whether Sativex, a cannabinoid-based oral spray, could be used to help treat symptoms of agitation and aggression in dementia.
Currently Sativex is indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. To date there have been no studies looking at the potential benefits of this medicine for people with dementia, and there are some important questions that need to be answered before large-scale studies can be done.
A team of researchers based at King’s College London is running a phase II clinical trial to find out how feasible it is to give the medicine to people with dementia. Funded by Alzheimer’s Research UK, the researchers will also investigate how easy it is to run a trial across multiple nursing homes, which will help them to best design a larger phase III clinical trial.
To do this they are inviting people with Alzheimer’s disease between the ages of 55 and 90 to take part in the study. To take part, volunteers must be:
1. A resident in care home within Greater London/near London.
2. Clinically diagnosed with Alzheimer’s disease.
3. Experiencing regular anxiety, agitation and/or aggressive behaviours.
Volunteers will either receive a course of treatment with the cannabinoid-based medicine, which is given as an oral spray, or a dummy treatment known as a placebo. Those selected to take part in the trial will take part for four weeks and will begin the study on a low dose (one spray per day), building up to the top dose of four sprays a day by week three.
Katie Puckering, head of Information Services at Alzheimer’s Research UK said: “While a major focus for dementia research is to develop drugs that slow or stop the progression of the physical diseases that cause dementia, what really matters is that a medicine benefits people’s day-to-day lives.”
Alzheimer’s Research UK is funding the study. It has been approved by the West Midlands – Coventry & Warwickshire Research Ethics Committee & MHRA, and co-sponsored by King’s College London & SLaM NHS Trust. GW Pharmaceuticals, and Jazz Pharmaceuticals company, has provided the medicine for the study.