TY - JOUR
T1 - Sativex (nabiximols) for the treatment of Agitation & Aggression in Alzheimer's dementia in UK nursing homes
T2 - a randomised, double-blind, placebo-controlled feasibility trial
AU - Albertyn, Christopher P.
AU - Guu, Ta Wei
AU - Chu, Petrina
AU - Creese, Byron
AU - Young, Allan
AU - Velayudhan, Latha
AU - Bhattacharyya, Sagnik
AU - Jafari, Hassan
AU - Kaur, Simrat
AU - Kandangwa, Pooja
AU - Carter, Ben
AU - Aarsland, Dag
N1 - Publisher Copyright:
© 2025 The Author(s).
PY - 2025/6/1
Y1 - 2025/6/1
N2 - Background Alzheimer's Disease (ad) patients often experience clinically significant agitation, leading to distress, increased healthcare costs and earlier institutionalisation. Current treatments have limited efficacy and significant side effects. Cannabinoid-based therapies, such as the nabiximols oral spray (Sativex®; 1:1 delta-9-tetrahydrocannabinol and cannabidiol), offer potential alternatives. We aimed to explore the feasibility and safety of nabiximols as a potential treatment for agitation in ad. Methods The 'Sativex® for Agitation & Aggression in Alzheimer's Dementia' (STAND) trial was a randomised, double-blind, placebo-controlled, feasibility study conducted in UK care homes. Participants with probable ad and predefined clinically significant agitation were randomised to receive placebo or nabiximols for 4 weeks on an up-titrated schedule, followed by a 4-week observation period. To be considered feasible, we prespecified the following thresholds that needed to be met: randomising 60 participants within 12 months, achieving a ≥ 75% follow-up rate at 4 weeks, maintaining ≥80% adherence to allocation and estimating a minimum effect size (Cohen's d ≥ 0.3) on the Cohen-Mansfield Agitation Inventory. This trial is registered with ISRCTN 7163562. Findings Between October 2021 and June 2022, 53 candidates were assessed; 29 met eligibility criteria and were randomised. No participants withdrew, and adherence was high (100%) and was generally feasible to deliver. The intervention was well tolerated (0 adverse reactions), with no safety concerns reported. Interpretation Despite significant COVID-19 pandemic related challenges, administering nabiximols through oral mucosa to advanced ad patients with agitation demonstrated feasibility and safety. These findings support a larger confirmatory efficacy trial to evaluate the potential therapeutic efficacy of nabiximols for agitation in AD.
AB - Background Alzheimer's Disease (ad) patients often experience clinically significant agitation, leading to distress, increased healthcare costs and earlier institutionalisation. Current treatments have limited efficacy and significant side effects. Cannabinoid-based therapies, such as the nabiximols oral spray (Sativex®; 1:1 delta-9-tetrahydrocannabinol and cannabidiol), offer potential alternatives. We aimed to explore the feasibility and safety of nabiximols as a potential treatment for agitation in ad. Methods The 'Sativex® for Agitation & Aggression in Alzheimer's Dementia' (STAND) trial was a randomised, double-blind, placebo-controlled, feasibility study conducted in UK care homes. Participants with probable ad and predefined clinically significant agitation were randomised to receive placebo or nabiximols for 4 weeks on an up-titrated schedule, followed by a 4-week observation period. To be considered feasible, we prespecified the following thresholds that needed to be met: randomising 60 participants within 12 months, achieving a ≥ 75% follow-up rate at 4 weeks, maintaining ≥80% adherence to allocation and estimating a minimum effect size (Cohen's d ≥ 0.3) on the Cohen-Mansfield Agitation Inventory. This trial is registered with ISRCTN 7163562. Findings Between October 2021 and June 2022, 53 candidates were assessed; 29 met eligibility criteria and were randomised. No participants withdrew, and adherence was high (100%) and was generally feasible to deliver. The intervention was well tolerated (0 adverse reactions), with no safety concerns reported. Interpretation Despite significant COVID-19 pandemic related challenges, administering nabiximols through oral mucosa to advanced ad patients with agitation demonstrated feasibility and safety. These findings support a larger confirmatory efficacy trial to evaluate the potential therapeutic efficacy of nabiximols for agitation in AD.
KW - Alzheimer's disease
KW - behavioural and psychological symptoms of dementia
KW - cannabinoid-based medicine
KW - dementia
KW - neuropsychiatric symptoms
KW - older people
UR - http://www.scopus.com/inward/record.url?scp=105008241545&partnerID=8YFLogxK
U2 - 10.1093/ageing/afaf149
DO - 10.1093/ageing/afaf149
M3 - Article
C2 - 40479610
AN - SCOPUS:105008241545
SN - 0002-0729
VL - 54
JO - Age and Ageing
JF - Age and Ageing
IS - 6
M1 - afaf149
ER -