AIT 082 IN MILD ALZHEIMERS DISEASE PATIENTS

AIT-082是一种治疗阿尔茨海默病（Alzheimer' disease，AD）的新药。 临床前实验表明，AIT-082具有增强记忆和神经营养特性。 两个先前的单剂量，1期研究与AIT-082已显示出良好的安全性和耐受性在人类。这项1B期临床试验旨在评估AIT-082在诊断为轻度阿尔茨海默病患者中的多次给药安全性，耐受性和药代动力学。 本研究将在四个普通临床研究中心进行。 将招募36例患者（每个临床试验机构9例）。 每名患者将每天接受口服剂量的AIT-082或安慰剂，持续一周。 将患者分为3个递增剂量队列，每个队列12例患者。 每个群组将由随机分配至AIT-082剂量（100 mg/天、500 mg/天或2000 mg/天）的八名患者加上安慰剂的四名患者组成。 在整个研究期间，将观察患者的不良反应。 将采集血液以确定AIT-082多次给药的药代动力学参数。 将收集初步疗效数据。 神经心理学测试将用于评估AIT-082对AD中认知和记忆的可能短期影响。

AIT-082 is being developed as a new therapeutic agent for Alzheimer' disease (AD). Preclinical experiments indicate that AIT-082 has memory enhancing and neurotrophic properties. Two prior single-dose, Phase 1 studies with AIT-082 have shown good safety and tolerability in humans. This Phase 1B clinical trial is designed to assess multiple-dose safety, tolerability and pharmacokinetics of AIT-082 in patients diagnosed with mild Alzheimer's disease. The study will be conducted at four sites with General Clinical Research Centers. Thirty-six patients will be recruited (nine at each clinical site). Each patient will receive an oral dose of AIT-082 or placebo, daily for one week. Patients will be divided into three escalating dose cohorts, 12 patients each. Each cohort will consist of eight patients randomized to a dose of AIT-082 (100mg/day, 500mg/day or 2000 mg/day) plus four patients to placebo. Patients will be observed for adverse reactions throughout the study. Blood will be collected to determine the pharmacokinetic parameters of AIT-082 with multiple dosing. Preliminary efficacy data will be collected. Neuropsychological tests will be used to assess possible short-term effects of AIT-082 on cognition and memory in AD.