A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-126 in Subjects With Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Safety and tolerability assessments
研究概览
简要总结
This study will investigate safety, tolerability and pharmacokinetics of ABT-126 in up to 20 male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.
详细描述
This is a double-blind, placebo-controlled, randomized, multiple-dose, parallel group, multicenter study. Up to 20 male and female subjects with mild to moderate Alzheimer's disease (AD) who are taking stable doses of acetylcholinesterase inhibitors will be enrolled in this study. The study will be conducted in up to four sites. Within 28 days prior to study drug administration, subjects will be screened based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD, Mini-Mental State Examination (MMSE) and Modified Hachinski Ischemic Scale (MHIS) scores, medical history, physical examination, neurological examination, vital signs, ECG, laboratory tests and response to Columbia-Suicide Severity Rating Scale (C-SSRS).
Subjects will be divided into two groups of 10 subjects each. In each group, 8 subjects will receive ABT-126 and two subjects will receive matching placebo. Group 1 will be administered Dose 1 of ABT-126 or placebo. Group 2 will be administered Dose 2 ABT-126 or placebo. All doses will be administered once daily in the morning for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
干预措施: Placebo (Drug)
Group 1
干预措施: ABT-126 (Drug)
Group 2
干预措施: ABT-126 (Drug)
Group 2
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability assessments
时间窗: From Day 1 through Day 17
vital signs, electrocardiogram (ECG), neurological examination, laboratory tests, number of subjects with adverse events, Columbia-Suicide Severity Rating Scale (C-SSRS)
次要结局
- Pharmacokinetic evaluation profile(Blood collection prior to, and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 72, 120, and 168 hours after dosing on Day 10)
