AIT 082 IN MILD ALZHEIMERS DISEASE PATIENTS

AIT-082是一种治疗阿尔茨海默病(AD)的新药物。临床前实验表明，AIT-082具有增强记忆和神经营养的特性。之前两项使用AIT-082的单剂量1期研究已经显示出良好的安全性和人类耐受性。这项1B期临床试验旨在评估AIT-082在被诊断为轻度阿尔茨海默病的患者中的多剂量安全性、耐受性和药代动力学。这项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(每个临床地点9名)。每个患者都将接受口服剂量的AIT-082或安慰剂，为期一周。患者将被分成三个递增剂量队列，每个队列12名患者。每个队列由8名患者随机组成，分别服用AIT-082(100毫克/天、500毫克/天或2000毫克/天)和4名患者服用安慰剂。在整个研究过程中，将观察患者的不良反应。采血测定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患者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.