Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy; Regional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, Italy.
Department of Experimental Medicine, Pharmacology Division, University of Campania "L. Vanvitelli", 80138 Naples, Italy.
Biomed Pharmacother. 2022 Sep;153:113488. doi: 10.1016/j.biopha.2022.113488. Epub 2022 Aug 4.
Up to 80 % nursing home residents with dementia experiences chronic pain. Contextually, 97 % presents fluctuant neuropsychiatric symptoms (NPS). Among the most challenging is agitation, connected with undertreated pain and managed through neuroleptics doubling death risk. Evidence is accumulating in favor of the involvement of the endocannabinoid system in nociception and NPS. This double-blind, placebo-controlled, randomized trial (NAbiximols Clinical Translation To the treatment of Pain and Agitation In Severe Dementia [NACTOPAISD]) aims at investigating efficacy and safety of oral spray nabiximols, containing Δ9-tetrahydrocannabinol and cannabidiol (Sativex®), for pain and agitation treatment in severe dementia patients (Mini-Mental State Examination ≤ 12) over 65. The coprimary endpoints are efficacy on pain and agitation, assessed through the recently validated Italian Mobilization-Observation-Behavior-Intensity-Dementia and the Cohen-Mansfield Agitation Inventory. The secondary endpoint is the evaluation of efficacy duration after wash-out and the assessment of quality of life through the DEMQOL. Any adverse events will be reported. The results undergo statistical analysis plan. NACTOPAISD might provide rationale for a translational safer pain and agitation treatment in severe dementia. It is approved by Calabria Region Ethics Committee and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and the Consolidated Standards of Reporting Trials (CONSORT) statements.
高达 80%的养老院痴呆症患者患有慢性疼痛。从上下文可以看出，97%的患者表现出波动性神经精神症状（NPS）。其中最具挑战性的是躁动，与未得到充分治疗的疼痛有关，并通过神经安定剂治疗，使死亡风险增加一倍。越来越多的证据表明内源性大麻素系统参与伤害感受和 NPS。这项双盲、安慰剂对照、随机试验（NAbiximols 临床转化为严重痴呆疼痛和躁动的治疗 [NACTOPAISD]）旨在研究含有 Δ9-四氢大麻酚和大麻二酚的口服喷雾 Nabiximols 治疗严重痴呆患者（Mini-Mental State Examination ≤ 12）疼痛和躁动的疗效和安全性，年龄超过 65 岁。主要终点是通过最近验证的意大利 Mobilization-Observation-Behavior-Intensity-Dementia 和 Cohen-Mansfield 躁动量表评估疼痛和躁动的疗效。次要终点是评估洗脱后疗效持续时间，并通过 DEMQOL 评估生活质量。任何不良事件都将报告。结果将根据统计分析计划进行分析。NACTOPAISD 可能为严重痴呆症患者提供更安全的疼痛和躁动治疗的转化依据。它已获得卡拉布里亚地区伦理委员会的批准，并遵循标准干预试验报告项目（SPIRIT）和临床试验报告标准（CONSORT）声明。
