Objectives: Alzheimer's disease (AD) is the most common cause of dementia worldwide in the older population. There is no disease-modifying therapy available for AD. The current standard of care drug therapy for AD is cholinesterase inhibitors, including donepezil. Bacopa monnieri or brahmi is used in traditional Indian medicine for memory loss. We conducted a phase 2b randomized controlled trial (RCT) to find out the efficacy of brahmi and donepezil in AD and mild cognitive impairment (MCI). Patients and Methods: The study was planned as a 52 week, randomized, double-blind, parallel-group, phase-2 single-center clinical trial comparing the efficacy and safety of Bacopa monnieri (brahmi) 300 mg OD and donepezil 10 mg OD for 12 months in 48 patients with AD and MCI-AD including cognitive and quality of life outcomes. The primary outcome was differences in the change from baseline of the neuropsychological tests [Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog) and postgraduate institute (PGI) memory scale] at 12 months between the intervention group (brahmi) and active comparison group (donepezil). Results: The study was terminated after 3 years and 9 months, after recruiting 34 patients, because of slow recruitment and a high dropout rate. Intention to treat analysis after adjusting for baseline confounders showed no difference in the rate of change in ADAS-Cog score from baseline at any time point, including the last follow-up. There was no difference in the rate of change in PGI Memory scale (PGIMS) at 3, 6, and 9 months. In the last follow-up, there was a significant difference in the change in total PGIMS score between brahmi and donepezil, while there was no difference in individual scores of the PGI memory scale. Conclusion: This phase-2 RCT on the efficacy of brahmi vs. donepezil showed no significant difference between them after 1 year of treatment. Larger phase-3 trials, preferably multicentric, are required to find the superiority of brahmi over donepezil.

中文翻译：

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假马齿苋（婆罗米）和多奈哌齐对阿尔茨海默病和轻度认知障碍的疗效：一项随机双盲平行 2b 期研究

目的：阿尔茨海默病 (AD) 是全球老年人群中最常见的痴呆症原因。没有可用于 AD 的疾病缓解疗法。目前治疗 AD 的标准药物治疗是胆碱酯酶抑制剂，包括多奈哌齐。Bacopa monnieri或 brahmi 用于传统印度医学中用于记忆丧失。我们进行了一项 2b 期随机对照试验 (RCT)，以了解婆罗米和多奈哌齐对 AD 和轻度认知障碍 (MCI) 的疗效。患者和方法：该研究计划为一项为期 52 周、随机、双盲、平行组、2 期单中心临床试验，比较假马齿苋的疗效和安全性(brahmi) 300 mg OD 和多奈哌齐 10 mg OD 治疗 12 个月，用于 48 名 AD 和 MCI-AD 患者，包括认知和生活质量结果。主要结果是干预组 (brahmi) 和积极对照组在 12 个月时神经心理学测试 [阿尔茨海默病评估量表-认知分量表 (ADAS-Cog) 和研究生院 (PGI) 记忆量表] 的基线变化差异（多奈哌齐）。结果：该研究在招募 34 名患者后在 3 年零 9 个月后终止，原因是招募缓慢且辍学率高。调整基线混杂因素后的意向治疗分析显示，在任何时间点（包括最后一次随访），ADAS-Cog 评分与基线的变化率均无差异。在 3、6 和 9 个月时，PGI 记忆量表 (PGIMS) 的变化率没有差异。末次随访中，婆罗米与多奈哌齐的 PGIMS 总分变化存在显着差异，而 PGI 记忆量表的个体得分无差异。结论：这项关于婆罗米与多奈哌齐疗效的 2 期 RCT 显示，治疗 1 年后两者之间没有显着差异。需要更大规模的 3 期试验，最好是多中心试验，以发现婆罗米优于多奈哌齐。