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
Centre for Healthy Brain Ageing, Department of Psychological Medicine, King's College London Institute of Psychiatry, Psychology & Neuroscience, London, UK.
Division of Psychiatry, Department of Internal Medicine, China Medical University Beigang Hospital, Beigang, Taiwan.
Age Ageing. 2025 May 31;54(6). doi: 10.1093/ageing/afaf149.
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.
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.
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.
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.
阿尔茨海默病（AD）患者常出现具有临床意义的激越症状，导致痛苦、医疗费用增加以及更早地入住机构。目前的治疗方法疗效有限且副作用显著。基于大麻素的疗法，如纳比西莫尔口腔喷雾剂（Sativex®；1:1的Δ⁹-四氢大麻酚和大麻二酚），提供了潜在的替代方案。我们旨在探讨纳比西莫尔作为AD激越潜在治疗方法的可行性和安全性。
“用于阿尔茨海默病痴呆激越与攻击行为的Sativex®”（STAND）试验是一项在英国养老院进行的随机、双盲、安慰剂对照的可行性研究。患有可能的AD且有预定义的具有临床意义的激越症状的参与者被随机分配接受安慰剂或纳比西莫尔，按递增剂量方案给药4周，随后是4周的观察期。为了被认为可行，我们预先设定了需要满足的以下阈值：在12个月内随机分配60名参与者，4周时随访率≥75%，维持对分配的依从性≥80%，并估计对科恩-曼斯菲尔德激越量表的最小效应量（科恩d≥0.3）。该试验已在国际标准随机对照试验编号（ISRCTN）7163562注册。
2021年10月至2022年6月期间，评估了53名候选人；29名符合入选标准并被随机分组。没有参与者退出，依从性很高（100%），总体上给药可行。干预耐受性良好（0例不良反应），未报告安全问题。
尽管存在与2019冠状病毒病大流行相关的重大挑战，但通过口腔黏膜给患有激越症状的晚期AD患者使用纳比西莫尔证明了其可行性和安全性。这些发现支持进行更大规模的验证性疗效试验，以评估纳比西莫尔对AD激越的潜在治疗效果。
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