NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.
South Western Sydney Clinical School, University of New South Wales, Kensington, NSW, Australia.
PLoS One. 2023 Mar 15;18(3):e0265285. doi: 10.1371/journal.pone.0265285. eCollection 2023.
Vascular dementia (VaD) accounts for 15-20% of all dementia cases. It is a syndrome of acquired cognitive impairment with a complex pathophysiological basis. A novel herbal formulation (Sailuotong; SLT) consisting of Panax ginseng C.A Mey, Ginkgo biloba L and Crocus sativus L extracts was developed to treat VaD. Preclinical animal studies found significant improvements in memory and in pathogenic biochemical parameters. Appropriate safety of SLT was shown in acute and chronic toxicity studies, and early clinical trials of SLT demonstrated enhancements in cognition in VaD patients. A fully powered study with a long intervention period is needed to confirm the efficacy and safety of this novel intervention. A rigorous phase III clinical trial was developed with the aim of recruiting 238 patients diagnosed with mild to moderate probable VaD, or VaD mixed with Alzheimer's disease (where cerebrovascular disease is the clinical dominant contributor to dementia, abbreviated as CVD+AD). Using a permuted block strategy, participants will be randomly allocated to receive SLT (120 mg bd) or placebo capsules for an intervention period of 52 weeks and will be followed-up for an additional 13 weeks. The primary outcome measures are the Vascular Dementia Assessment Scale-cognitive subscale and Alzheimer's Disease Cooperative Study-Activities of Daily Living scale. Secondary outcome measures include the Clinician's Interview Based Impression of Change-Plus, CLOX, EXIT-25, Neuropsychiatric Inventory-Clinician rating scale, and Dementia Quality of Life questionnaire. Safety is assessed through adverse event reports and liver, renal, and coagulation studies. Primary and secondary outcome measures will be compared between treatment and placebo groups, using intention to treat and per protocol analyses. We hypothesise that a 52-week treatment of SLT will be clinically effective and well tolerated in participants with VaD or AD+CVD. This project will provide vital efficacy and safety data for this novel treatment approach to VaD.
血管性痴呆 (VaD) 占所有痴呆病例的 15-20%。它是一种获得性认知障碍综合征，具有复杂的病理生理基础。一种新的草药配方（银杏蜜环口服溶液；SLT）由人参、银杏叶和西红花提取物组成，用于治疗 VaD。临床前动物研究发现，记忆力和致病生化参数有显著改善。急性和慢性毒性研究表明 SLT 具有适当的安全性，早期 SLT 临床试验表明 VaD 患者的认知能力得到提高。需要一项具有长期干预期的大型研究来证实这种新干预措施的疗效和安全性。一项严格的 III 期临床试验正在进行中，旨在招募 238 名轻度至中度可能的 VaD 患者，或 VaD 合并阿尔茨海默病（其中脑血管疾病是痴呆的临床主要贡献因素，缩写为 CVD+AD）患者。采用置换块策略，参与者将被随机分配接受 SLT（120mg 每日两次）或安慰剂胶囊治疗，干预期为 52 周，并随访 13 周。主要结局指标是血管性痴呆评估量表认知分量表和阿尔茨海默病合作研究日常生活活动量表。次要结局指标包括临床医生访谈基于变化的印象-Plus、CLOX、EXIT-25、神经精神病学临床评定量表和痴呆生活质量问卷。安全性通过不良事件报告和肝、肾和凝血研究进行评估。使用意向治疗和方案分析，比较治疗组和安慰剂组的主要和次要结局指标。我们假设 SLT 治疗 52 周将在 VaD 或 AD+CVD 患者中具有临床疗效且耐受性良好。该项目将为 VaD 的这种新治疗方法提供重要的疗效和安全性数据。
