AIT 082 IN MILD ALZHEIMERS DISEASE PATIENTS

AIT 082 在轻度阿尔茨海默病患者中的应用

基本信息

批准号：
6303490
负责人：
JUDITH L HEIDEBRINK
金额：
$ 0.02万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
起止时间：
1999-12-01 至 2001-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6303490
关键词：
Alzheimer's disease blood chemistry brain disorder chemotherapy clinical research clinical trial phase I cognition drug adverse effect drug screening /evaluation human subject human therapy evaluation hypoxanthines memory neuropsychological tests p aminobenzoate pharmacokinetics purine analog

项目摘要

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.

AIT-082 正在开发作为阿尔茨海默病 (AD) 的新治疗剂。临床前实验表明 AIT-082 具有增强记忆和神经营养的特性。之前两项针对 AIT-082 的单剂量 1 期研究已显示出对人类良好的安全性和耐受性。该 1B 期临床试验旨在评估 AIT-082 在诊断患有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。该研究将在四个地点的普通临床研究中心进行。将招募 36 名患者（每个临床中心 9 名）。每位患者将每天口服 AIT-082 或安慰剂，持续一周。患者将被分为三个递增剂量组，每组 12 名患者。每个队列将由 8 名随机接受 AIT-082 剂量（100 毫克/天、500 毫克/天或 2000 毫克/天）的患者以及 4 名安慰剂患者组成。在整个研究过程中将观察患者的不良反应。将采集血液以确定多次给药的 AIT-082 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 认知和记忆可能的短期影响。