Available datapackage for study 'A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)'

The purpose of this study is to assess the efficacy and safety of lanabecestat compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the hypothesis that lanabecestat is a disease-modifying treatment for participants with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2 lanabecestat treatment groups compared with placebo.

本研究旨在评估拉那贝西司他（lanabecestat）对比安慰剂给药104周治疗早期阿尔茨海默病的有效性与安全性。本研究将验证如下假说：拉那贝西司他可作为疾病修饰治疗药物，应用于早期阿尔茨海默病受试者——此类受试者属于连续疾病谱人群，涵盖因阿尔茨海默病导致的轻度认知障碍（Mild Cognitive Impairment, MCI）患者，以及确诊为阿尔茨海默病型轻度痴呆患者；验证指标为第104周时，两个拉那贝西司他治疗组相较于安慰剂组，在13项阿尔茨海默病评定量表-认知分量表（Alzheimer's Disease Assessment Scale - Cognitive Subscale, ADAS-Cog13）上得分较基线的变化值。