抗阿尔茨海默病药物Ⅲ期临床试验评估指标综述

Review of Evaluation Indexes for Phase Ⅲ Clinical Trials of Anti Alzheimer's Drugs

阿尔茨海默病(AD)为神经退行性疾病,临床表现为认知和日常生活功能受损。目前认为其发病原因为β-淀粉样蛋白沉积形成的老年斑和高度磷酸化Tau蛋白所致的神经元纤维缠结导致的神经元大量凋亡。除已上市的胆碱酯酶抑制剂和N-甲基-D-天冬氨酸受体拮抗剂,近20年已有多种AD治疗药物包括国内完全自主知识产权的1类化学药品进入Ⅲ期临床试验。该文概述了目前AD对症治疗药物和对因治疗药物的Ⅲ期临床试验评估指标。

Alzheimer＇s disease（AD） is a neur ode generative disorder characterized by impaired cognitive and daily life functions. At present, itis believed that the pathogenesis of AD is caused by a great deal of apoptosis of the nurons, which induced by the entanglement of senile plaques formed by P - amyloid protein deposition and neuronal fibers induced by highly phosphorylted Tau protein. In addition to the commercially available cholinesterase inhibitors and N - methyl - D - asparate receptor antagonists, a ing a kind of pharmaceuticals with completely independent intellectual property rights in China, have entered phase I clinical trials in the past 20 years. This paper summarizes the current evaluation indexes of symptom - based drugs and pathogenesis - based drugs for AD in phase I clinical trials.