Sativex® for the treatment of Agitation & Aggression in Alzheimer’s Dementia in UK nursing homes (STAND): Protocol for a feasibility randomised controlled trial

Abstract

Background: People living with dementia often experience a myriad of behavioural and psychological symptoms of dementia (BPSD). Agitation is highly common within BPSD, negatively impacting their health, accelerating dementia progression, and is distressing both to patients and those caring for them. It also costs society a great deal, with increased hospitalisations, cost of care and earlier institutionalisation. Unfortunately, current treatments for these symptoms do not work very well and have a lot of unwanted side-effects. Recently, cannabinoid-based medicines have emerged as potentially safer alternative candidates for agitation in dementia. However, there is little systematic and robust evidence to support these encouraging early reports. Therefore, we specifically hope to investigate Sativex®, administered as an oral-spray, containing 50% delta-9-tetrahydrocannabinol (THC) and 50% cannabidiol (CBD) for agitation in dementia. Methods: STAND is a mixed-methods, randomised, double-blind, parallel group, placebo-controlled feasibility clinical trial, recruiting 60 people living with Alzheimer’s disease displaying behavioural symptoms from UK nursing homes. Conclusions: We aim to assess the safety, feasibility and acceptability of Sativex® within a nursing home context, and estimate its efficacy for agitation in Alzheimer’s disease. Findings will be used to inform a potential larger phase III confirmatory effectiveness trial. ISRCTN registry: 97163562.