AIT 082 IN MILD ALZHEIMERS DISEASE PATIENTS

AIT-082是一种治疗阿尔茨海默病（AD）的新型药物。临床前实验表明AIT-082具有增强记忆和神经营养的作用。AIT-082先前的两项单剂量一期研究显示出良好的安全性和人体耐受性。该1B期临床试验旨在评估AIT-082在轻度阿尔茨海默病患者的多剂量安全性、耐受性和药代动力学。该研究将在普通临床研究中心的四个地点进行。将招募36名患者（每个临床点9名）。每位患者将接受口服剂量的AIT-082或安慰剂，持续一周。患者将被分为三个剂量递增的队列，每组12名患者。每个队列将由8名患者组成，随机分配给AIT-082剂量（100mg/天、500mg/天或2000mg /天），另外4名患者接受安慰剂。在整个研究过程中观察患者的不良反应。采集血液，确定AIT-082在多剂量下的药代动力学参数。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患者认知和记忆可能的短期影响。

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.