Bartschi Jessica G, Greenwood Lisa-Marie, Montgomery Amy, Dortants Lon, Weston-Green Katrina, Huang Xu-Feng, Pai Nagesh, Potter Jan, Schira Mark M, Croft Rodney, Solowij Nadia
School of Psychology, Faculty of the Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, Australia.
Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia.
Cannabis Cannabinoid Res. 2023 Apr;8(2):348-359. doi: 10.1089/can.2021.0209. Epub 2022 Aug 30.
The slowing of disease progression in dementia in the early stages of diagnosis is paramount to improving the quality of life for those diagnosed and their support networks. Accumulating evidence suggests that CBD, a constituent of , is associated with neuroprotective, neuroendocrine, and psychotherapeutic effects, suggesting that it may be beneficial to dementia treatment. However, no published human study to date has examined this possibility. This trial aims to determine whether daily treatment with CBD over a 12-week period is associated with improved neurobiological, behavioral, and psychological outcomes in individuals living with early-stage dementia. Sixty participants with early-stage dementia will be recruited for a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomized into either 99.9% pure CBD or placebo treatment conditions and administered two capsules per day for 12 weeks. Participants will commence a 200 mg/day dose for 2 weeks before escalating to 300 mg/day for the remaining 10 weeks. Neuroimaging and blood-based neuroendocrine profiles will be assessed at baseline and post-treatment. Psychological and behavioral symptoms will be assessed at baseline, 6 weeks, and post-treatment. Monitoring of health and side-effects will be conducted through weekly home visits. This study is among the first to investigate the effects of isolated CBD in improving neuroanatomical and neuroendocrine changes, alongside psychological symptoms, during the early stages of dementia diagnosis. The outcomes of this trial have the capacity to inform a potential novel and accessible treatment approach for individuals living with early-stage dementia, and in turn, improve quality of life, prognoses, and treatment outcomes. This trial has been registered with the Therapeutic Goods Administration (CT-2020-CTN-03849-1v2) and the Australian and New Zealand Clinical Trials Registry (ACTRN12621001364864).
在痴呆症诊断的早期阶段减缓疾病进展对于提高确诊患者及其支持网络的生活质量至关重要。越来越多的证据表明，大麻二酚（CBD，大麻的一种成分）具有神经保护、神经内分泌和心理治疗作用，这表明它可能对痴呆症治疗有益。然而，迄今为止，尚无已发表的人体研究探讨过这种可能性。本试验旨在确定在12周内每日使用CBD治疗是否与早期痴呆症患者神经生物学、行为和心理状况的改善相关。60名早期痴呆症患者将被招募参加一项随机、双盲、安慰剂对照的临床试验。参与者将被随机分为接受99.9%纯CBD治疗组或安慰剂治疗组，每天服用两粒胶囊，持续12周。参与者将在开始时每天服用200毫克剂量，持续2周，然后在剩余的10周内将剂量增加到每天300毫克。在基线期和治疗后将评估神经影像学和基于血液的神经内分泌特征。心理和行为症状将在基线期、6周和治疗后进行评估。通过每周的家访来监测健康状况和副作用。本研究是首批调查在痴呆症诊断早期阶段，分离出的CBD对改善神经解剖和神经内分泌变化以及心理症状影响的研究之一。该试验的结果有能力为早期痴呆症患者提供一种潜在的新型且可及的治疗方法，进而改善生活质量、预后和治疗效果。本试验已在治疗用品管理局（CT - 2020 - CTN - 03849 - 1v2）以及澳大利亚和新西兰临床试验注册中心（ACTRN12621001364864）注册。
