Nabiximols spray was feasible and safe for treating agitation in Alzheimer's patients | Research

The takeaway

A feasibility trial found that nabiximols (1:1 THC:CBD oral spray) was safe and well-tolerated for treating agitation in nursing home residents with Alzheimer's disease, with zero adverse reactions reported.

Dementia care clinicians, geriatric psychiatrists, Alzheimer's disease researchers

Zero adverse reactions with 100% treatment adherence

What the researchers found

In a randomized, double-blind, placebo-controlled feasibility trial, 29 nursing home residents with Alzheimer's disease and clinically significant agitation were randomized to nabiximols or placebo for 4 weeks. No participants withdrew, adherence was 100%, and the intervention was well tolerated with zero adverse reactions reported. While the recruitment target of 60 was not met due to COVID-19 challenges, the trial demonstrated that administering oral mucosal spray to advanced AD patients with agitation was generally feasible.

Why it matters

Agitation in Alzheimer's disease causes significant distress and currently available treatments have limited efficacy with substantial side effects. This feasibility trial establishes that a cannabinoid-based approach can be safely delivered in nursing home settings, clearing the path for larger efficacy trials.

The numbers in context

29 randomized (target was 60); 0 withdrawals; 100% adherence; 0 adverse reactions; 4-week treatment + 4-week observation; trial conducted October 2021-June 2022

How the study worked

Randomized, double-blind, placebo-controlled feasibility study (STAND trial) in UK care homes. Participants with probable Alzheimer's disease and predefined clinically significant agitation were randomized to nabiximols or placebo for 4 weeks on an up-titrated schedule, followed by 4-week observation. Prespecified feasibility thresholds assessed.

What this study cannot tell us

Feasibility study not powered for efficacy outcomes. Did not meet recruitment target (29 of 60) due to COVID-19. Short 4-week treatment period. UK nursing home setting may not generalize to other care contexts. Efficacy remains unproven.

How to read the evidence

Well-designed RCT provides strong safety and feasibility data, but under-recruitment and lack of efficacy outcomes limit conclusions about therapeutic benefit.

When this study was published

2025 publication; trial conducted October 2021-June 2022; registered as ISRCTN 7163562

The bigger picture

Agitation is one of the most challenging behavioral symptoms in dementia care, often leading to antipsychotic prescribing despite known risks. Cannabinoid-based alternatives could fill a significant treatment gap if efficacy trials confirm the safety signals from this feasibility study.

Questions still open

Will the planned larger efficacy trial confirm that nabiximols reduces agitation in Alzheimer's patients? What is the optimal dosing schedule for this population?

Common questions

What is nabiximols?

Nabiximols (brand name Sativex) is a pharmaceutical oral spray containing a 1:1 ratio of THC and CBD derived from cannabis. It is already approved in several countries for multiple sclerosis spasticity.

Did the study show nabiximols works for agitation?

This was a feasibility study designed to test whether the treatment could be safely delivered, not whether it works. It showed the approach is safe and feasible, but a larger trial is needed to test actual efficacy against agitation.

Read the original research

Sativex (nabiximols) for the treatment of Agitation & Aggression in Alzheimer's dementia in UK nursing homes: a randomised, double-blind, placebo-controlled feasibility trial.

Age and ageing, 54(6)

View on PubMed ↗Publisher’s paper ↗

Citation

Albertyn, Christopher P; Guu, Ta-Wei; Chu, Petrina; Creese, Byron; Young, Allan; Velayudhan, Latha; Bhattacharyya, Sagnik; Jafari, Hassan; Kaur, Simrat; Kandangwa, Pooja; Carter, Ben; Aarsland, Dag. (2025). Sativex (nabiximols) for the treatment of Agitation & Aggression in Alzheimer's dementia in UK nursing homes: a randomised, double-blind, placebo-controlled feasibility trial.. Age and ageing, 54(6). https://doi.org/10.1093/ageing/afaf149