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Randomized Controlled Trial
. 2025 May 31;54(6):afaf149.
doi: 10.1093/ageing/afaf149.

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

Christopher P Albertyn  1 , Ta-Wei Guu  1   2 , Petrina Chu  3 , Byron Creese  4 , Allan Young  5 , Latha Velayudhan  1 , Sagnik Bhattacharyya  5 , Hassan Jafari  3 , Simrat Kaur  1 , Pooja Kandangwa  1 , Ben Carter  6 , Dag Aarsland  7   8
Affiliations
Randomized Controlled Trial

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

Christopher P Albertyn et al. Age Ageing. .

Abstract

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.

Keywords: Alzheimer’s disease; behavioural and psychological symptoms of dementia; cannabinoid-based medicine; dementia; neuropsychiatric symptoms; older people.

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Conflict of interest statement

T.W.G. is/has been supported by the grants from the Taiwanese Ministry of Education, the National Science and Technology Council, Taiwan, the Elite Physician fund, China Medical University Beigang Hospital, Taiwan, the Alzheimer’s Association, US and the Alzheimer’s Research UK. L.V. is/has been supported by grants from the NIHR, UK; Psychiatry Research trust; Parkinson’s UK; Rosetrees Trust; Alzheimer’s Research UK. S.B. is/has been supported by grants from the NIHR, UK; Wellcome trust; Psychiatry Research trust; Parkinson’s UK; Rosetrees Trust; Alzheimer’s Research UK. S.B. has participated in advisory boards for or received research funding from EmpowerPharm/SanteCannabis and NW PharmaTech Ltd. All of these honoraria/funding were received as contributions towards research support through King’s College London and not personally. S.B. also had a collaboration with Beckley Canopy Therapeutics/Canopy Growth (investigator-initiated research) wherein they supplied study drug for free for charity (Parkinson’s UK) and NIHR (BRC) funded research.

Figures

Figure 1
Figure 1
Trial profile. *Screened residents may have been ineligible for more than one reason.
Figure 2
Figure 2
Marginal estimate for CMAI (a) and NPI-NH (b) scores by treatment arm.
See this image and copyright information in PMC

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References

    1. Livingston G, Huntley J, Liu KY et al. Dementia prevention, intervention, and care: 2024 report of the lancet standing commission. Lancet 2024;404:572–628. 10.1016/S0140-6736(24)01296-0. - DOI - PubMed
    1. Laganà V, Bruno F, Altomari N et al. Neuropsychiatric or behavioral and psychological symptoms of dementia (BPSD): focus on prevalence and natural history in Alzheimer’s disease and frontotemporal dementia. Front Neurol 2022;13:1–9. 10.3389/fneur.2022.832199. - DOI - PMC - PubMed
    1. Cummings J, Sano M, Auer S et al. Reduction and prevention of agitation in persons with neurocognitive disorders: an international psychogeriatric association consensus algorithm. Int Psychogeriatr 2024;36:251–62. 10.1017/S104161022200103X. - DOI - PMC - PubMed
    1. Sano M, Cummings J, Auer S et al. Agitation in cognitive disorders: progress in the international psychogeriatric association consensus clinical and research definition. Int Psychogeriatr 2024;36:238–50. 10.1017/S1041610222001041. - DOI - PMC - PubMed
    1. Aldridge Z, Ponnusamy K, Noble A et al. Dementia in care homes: increasing the diagnosis rate among undiagnosed residents. Nurs Older People 2024;35:22–7. 10.7748/nop.2023.e1435. - DOI - PubMed

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