A Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Pharmacokinetic evaluation of the two ABT-957 diastereomers
研究概览
简要总结
This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's disease (AD);
- •Has a Mini-Mental State Examination total score of 16 to 26;
- •Has a Modified Hachinski Ischemia Scale score of ≤ 4;
- •Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30 days;
- •Has had a computerized tomography or magnetic resonance imaging. The scan must not show evidence for an alternative etiology for dementia;
- •With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, is in general good health.
排除标准
- •Positive screen for drugs of abuse, alcohol or cotinine;
- •Females must not have positive results for pregnancy;
- •Focal neurological signs on examination;
- •Has a clinically significant abnormal value, in serum chemistry, hematology or urinalysis;
- •History of any significant neurologic disease other than AD;
- •History of head trauma, motor vehicle accident, concussion.
研究组 & 干预措施
ABT-957
ABT-957 administered twice-daily for 7 days
干预措施: ABT-957 (Drug)
Placebo
Placebo administered twice-daily for 7 days
干预措施: Placebo for ABT-957 (Other)
结局指标
主要结局
Pharmacokinetic evaluation of the two ABT-957 diastereomers
时间窗: Day 7
maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), plasma concentration at the end of the dosing interval (Ctrough), the area under the plasma concentration-time curve (AUC) during each dosing interval (AUC0-12 and AUC12-24)
Number of subjects with adverse events
时间窗: Routinely for the duration of the study, about 7 months
Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
次要结局
未报告次要终点