Department of Pharmacology, National University Health System, Singapore, Singapore. cplhchen @ yahoo.com.sg
Cerebrovasc Dis. 2013;35 Suppl 1:23-9. doi: 10.1159/000346234. Epub 2013 Mar 14.
A substantial proportion of patients after nondisabling stroke are cognitively impaired compared to age- and education-matched community-dwelling controls. Moreover, poststroke patients who have 'vascular cognitive impairment no dementia' (VCIND) of moderate severity have a high risk of incident dementia, dependency and death. Further studies are urgently needed to demonstrate effective cognition-enhancing therapies in VCIND given the scarcity of evidence-based treatment options. NeuroAiD is a traditional Chinese medicine that has been shown to induce neuroplasticity, promote cell proliferation and stimulate the development of dense axonal and dendritic networks in animal stroke models. NeuroAiD may improve cerebral blood flow and functional recovery after stroke in patients.
To investigate the effects and tolerability of NeuroAiD II in patients with VCIND.
The NeuroAiD II (MLC901) in Vascular Cognitive Impairment Study (NEURITES) is a 24-week, double-blind, randomized, placebo-controlled phase II study of NeuroAiD II in patients with VCIND. The primary outcome is executive function as measured by the Verbal Fluency test. Secondary outcomes include cognitive assessments such as the ADAS-Cog, MoCA, MMSE and Cognitive Battery: activities of daily living as measured by the Alzhei-mer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale for mild cognitive impairment, behavior as measured by the Neuropsychiatric Inventory, and depression as measured by the Geriatric Depression Scale and the Beck Depression Scale. In addition, there will be novel exploratory outcomes: (a) magnetic resonance imaging of lesion location (structural imaging), structural integrity of white matter pathways (diffusion tensor imaging), neuronal function (resting studies) and perfusion (arterial spin labeling and MR angiography), and (b) retinal and optic nerve imaging. Safety and tolerability will be assessed using adverse events, laboratory tests and vital signs.
NEURITES has the potential to set new standards for the systematic evaluation of Asian traditional medicine for integration into standard medicine practice and establishing a novel therapeutic approach for improving cognition after stroke.
与年龄和教育相匹配的社区居住对照相比，相当一部分非致残性中风后患者存在认知障碍。此外，中度严重程度的“血管性认知障碍，非痴呆”（VCIND）中风后患者发生痴呆、依赖和死亡的风险很高。鉴于缺乏循证治疗选择，进一步的研究迫切需要证明 VCIND 中有增强认知作用的治疗方法。NeuroAiD 是一种中药，已被证明可诱导神经可塑性，促进细胞增殖，并刺激动物中风模型中密集的轴突和树突网络的发育。NeuroAiD 可能改善中风患者的脑血流和功能恢复。
研究 NeuroAiD II 对 VCIND 患者的疗效和耐受性。
NeuroAiD II（MLC901）在血管性认知障碍研究（NEURITES）中是一项为期 24 周的、双盲、随机、安慰剂对照的、NeuroAiD II 对 VCIND 患者的 II 期研究。主要结局是通过词语流畅性测试测量的执行功能。次要结局包括认知评估，如 ADAS-Cog、MoCA、MMSE 和认知电池：日常生活活动，由轻度认知障碍的阿尔茨海默病合作研究日常生活活动（ADCS-ADL）量表测量，行为，由神经精神病学评定量表测量，以及抑郁，由老年抑郁量表和贝克抑郁量表测量。此外，还将有新的探索性结局：（a）病变部位的磁共振成像（结构成像）、白质通路的结构完整性（弥散张量成像）、神经元功能（静息研究）和灌注（动脉自旋标记和磁共振血管造影），以及（b）视网膜和视神经成像。安全性和耐受性将通过不良事件、实验室检查和生命体征进行评估。
NEURITES 有可能为系统评估亚洲传统医学以纳入标准医学实践并建立改善中风后认知的新治疗方法树立新标准。
