[Translation] A multicenter, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial to evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of OAB-14 dry suspension in the treatment of Alzheimer's disease
主要目的:评价OAB-14干混悬剂相比安慰剂控制阿尔茨海默病患者疾病总体进展的疗效;
关键次要目的:评价OAB-14干混悬剂相比安慰剂控制阿尔茨海默病患者疾病进展的疗效。
次要目的:评价OAB-14干混悬剂相比安慰剂改善阿尔茨海默病患者认知和/或功能下降的疗效;评价OAB-14干混悬剂相比安慰剂减少脑内淀粉样斑块的疗效;评价OAB-14干混悬剂相比安慰剂改善阿尔茨海默病患者行为的疗效;评价OAB-14干混悬剂的安全性和耐受性;评价OAB-14干混悬剂在阿尔茨海默病患者中的药代动力学特征;
探索性目的:观察口服OAB-14干混悬剂后脑脊液中OAB-14的浓度;评价OAB-14干混悬剂相比安慰剂对脑脊液中生物标志物含量的影响;评价OAB-14干混悬剂相比安慰剂对血浆中生物标志物含量的影响;评价OAB-14干混悬剂相比安慰剂改善脑内神经元损伤的疗效
[Translation] Primary objective: To evaluate the efficacy of OAB-14 dry suspension compared with placebo in controlling the overall progression of the disease in patients with Alzheimer's disease;
Key secondary objective: To evaluate the efficacy of OAB-14 dry suspension compared with placebo in controlling the progression of the disease in patients with Alzheimer's disease.
Secondary objectives: To evaluate the efficacy of OAB-14 dry suspension in improving cognitive and/or functional decline in patients with Alzheimer's disease compared with placebo; To evaluate the efficacy of OAB-14 dry suspension in reducing amyloid plaques in the brain compared with placebo; To evaluate the efficacy of OAB-14 dry suspension in improving the behavior of patients with Alzheimer's disease compared with placebo; To evaluate the safety and tolerability of OAB-14 dry suspension; To evaluate the pharmacokinetic characteristics of OAB-14 dry suspension in patients with Alzheimer's disease;
Exploratory objectives: To observe the concentration of OAB-14 in cerebrospinal fluid after oral administration of OAB-14 dry suspension; To evaluate the effect of OAB-14 dry suspension on the content of biomarkers in cerebrospinal fluid compared with placebo; To evaluate the effect of OAB-14 dry suspension on the content of biomarkers in plasma compared with placebo; To evaluate the efficacy of OAB-14 dry suspension in improving neuronal damage in the brain compared with placebo