一项评估甘露特钠 (GV-971) 治疗轻、中度阿尔茨海默病患者安全性和有 效性的多中心、随机、双盲、安慰剂平行对照 3 期临床试验 [绿色记忆 (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)]
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial evaluating the safety and efficacy of sodium mannitol (GV-971) in patients with mild to moderate Alzheimer's disease [GREEN MEMORY : GREen Valley 971 EvaluatioN Memory)]
主要终点为评估与安慰剂相比 GV-971 在轻 、中度阿尔茨海默病 (AD) 受试者的认知和总 体功能方面的疗效。 次要终点有:评估与安慰剂相比 GV-971 对轻、中度 AD 受试者行为症状和认知损害的影响;评估与安慰剂相比 GV-971 对轻度至中度 AD 受试者日常生活活动能力 (ADL) 的影响;评估与安慰剂相比 GV-971 对轻、中度 AD 受试者的认知、功能及总体临床印象的短期疗效;评估与安慰剂相比轻、中度 AD 受试者 中 GV-971 的安全性和耐受性;评估 GV-971 对轻、中度 AD 受试者的 护理者/伴侣的影响;评估 GV-971 对资源利用的影响;评估 GV-971 在整个试验期间直至开放标签延展 (OLE) 阶段的有效性和安全性。探索性终点为评估轻、中度 AD 受试者中 GV-971 的群体药代动力学 (PK);评估 GV-971 对神经退行性变、炎症、 炎症细胞、肠道代谢物生物标记物、肠道菌群、淀粉样蛋白、 tau标记物和脑结构神经退行性变的影响。
[Translation] The primary endpoint was to evaluate the efficacy of GV-971 compared with placebo in subjects with mild to moderate Alzheimer's disease (AD) in terms of cognition and overall function. Secondary endpoints are: To evaluate the effect of GV-971 compared with placebo on behavioral symptoms and cognitive impairment in subjects with mild to moderate AD; to evaluate GV-971 compared to placebo in subjects with mild to moderate AD activities of daily living (ADL); to assess the short-term efficacy of GV-971 compared with placebo on cognition, function, and overall clinical impression in subjects with mild to moderate AD; to assess mild and moderate AD compared with placebo Safety and tolerability of GV-971 in subjects with moderate AD; assessing the effect of GV-971 on caregivers/partners of subjects with mild to moderate AD; assessing the effect of GV-971 on resource utilization; assessing Efficacy and safety of GV-971 throughout the trial period up to the open-label extension (OLE) phase. Exploratory endpoints were to assess the population pharmacokinetics (PK) of GV-971 in subjects with mild to moderate AD; to assess the effects of GV-971 on neurodegeneration, inflammation, inflammatory cells, gut metabolite biomarkers, Effects of gut microbiota, amyloid, tau markers, and brain structure on neurodegeneration.
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