STAND (Sativex® for the Treatment of AgitatioN in Dementia)
Research type
Research Study
Full title
A randomised feasibility trial investigating Sativex® for the treatment of the Agitation & Aggression (A/A) in Alzheimer’s Dementia.
IRAS ID
272703
Contact name
Rebecca Newton
Contact email
Sponsor organisation
King's College London
Eudract number
2020-001056-17
Duration of Study in the UK
2 years, 0 months, 29 days
Research summary
People living with dementia often experience a myriad of behavioural and psychological symptoms of dementia (BPSD). Anxiety and agitation are highly common within BPSD, negatively impacting their health, accelerating dementia progression, and are distressing both to patients and those caring for them. They also cost 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, cannabis-based medicinal products have emerged as potentially safer alternative candidates for agitation as they display effective anti-nausea, anti-anxiety and analgesic properties. However, there is little systematic and robust evidence support these encouraging early reports. Moreover, 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. This combination is particularly pertinent as THC reduces pain, anxiety and sleep disturbances; and CBD reduces delusions and hallucinations.
We will be conducting a mixed-methods, randomised, double-blind, parallel group, placebo-controlled phase II clinical trial, recruiting 60 people with dementia displaying behavioural symptoms from nursing homes, with the aim to assess the safety, feasibility & acceptability within a nursing home context, and estimate the effectiveness of Sativex® for agitation in dementia.
Lay summary of study results: The study aimed to include 60 participants but couldn’t due to the pandemic and a shorter recruitment period. Despite the challenges of running a trial in nursing homes during COVID-19, all participants stayed in the study, and the data collected was excellent. There were very few safety issues. Most participants followed the medication schedule well, though the definition of “adherence” might need to be updated in future studies. The analysis showed no clear link between the drug Sativex and the main neuropsychiatric outcomes, but the small number of participants and lack of precision should be taken into account. The safety and feasibility results support the need for a larger confirmatory trial to ascertain efficacy and effectiveness.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
20/WM/0210
Date of REC Opinion
14 Aug 2020
REC opinion
Further Information Favourable Opinion