Evidence map›Paper›PMID 40479610›Full record

Trial reportAge and ageing2025

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, Ta-Wei Guu, Petrina Chu, Byron Creese, Allan Young, Latha Velayudhan, Sagnik Bhattacharyya, Hassan Jafari, Simrat Kaur, Pooja Kandangwa and 2 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Age and ageing, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Christopher P AlbertynCentre for Healthy Brain Ageing, Department of Psychological Medicine, King's College London Institute of Psychiatry, Psychology & Neuroscience, London, UK.
Ta-Wei GuuCentre for Healthy Brain Ageing, Department of Psychological Medicine, King's College London Institute of Psychiatry, Psychology & Neuroscience, London, UK.
Petrina ChuDepartment of Biostatistics and Health Informatics, King's College London Institute of Psychiatry Psychology & Neuroscience, London, UK.
Byron CreeseDepartment of Life Sciences, Brunel University London, London, UK.
Allan YoungSchool of Academic Psychiatry, King's College London Institute of Psychiatry Psychology & Neuroscience, London, UK.
Latha VelayudhanCentre for Healthy Brain Ageing, Department of Psychological Medicine, King's College London Institute of Psychiatry, Psychology & Neuroscience, London, UK.ORCID 0000-0002-7712-930X
Sagnik BhattacharyyaSchool of Academic Psychiatry, King's College London Institute of Psychiatry Psychology & Neuroscience, London, UK.
Hassan JafariDepartment of Biostatistics and Health Informatics, King's College London Institute of Psychiatry Psychology & Neuroscience, London, UK.
Simrat KaurCentre for Healthy Brain Ageing, Department of Psychological Medicine, King's College London Institute of Psychiatry, Psychology & Neuroscience, London, UK.
Pooja KandangwaCentre for Healthy Brain Ageing, Department of Psychological Medicine, King's College London Institute of Psychiatry, Psychology & Neuroscience, London, UK.
Ben CarterBiostatistics and Health Informatics De Crespigny Park Denmark Hill, King's College London, London SE5 8AF, UK.ORCID 0000-0003-0318-8865
Dag AarslandDivision of Academic Psychiatry - Old Age Psychiatry, Institute of Psychiatry Psychology and Neuroscience, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlzheimer'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.

methodsThe '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.

findingsBetween 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.

interpretationDespite 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.

Indexed as

AggressionAlzheimer DiseaseCannabidiolDronabinolPlant ExtractsPsychomotor AgitationAgedAged, 80 and overDouble-Blind MethodDrug CombinationsFeasibility StudiesFemaleHumansMaleNursing HomesTreatment OutcomeCannabidiolDronabinolDrug CombinationsnabiximolsPlant ExtractsAlzheimer’s diseasebehavioural and psychological symptoms of dementiacannabinoid-based medicinedementianeuropsychiatric symptomsolder people

Identifiers

PMID40479610
PMCPMC12143470

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.