NCT00555204终止2 期
A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian Adaptive Design to Evaluate the Efficacy and Safety of ABT-089 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 337
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for 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
- •Patient has mild to moderate Alzheimer's disease
- •Patient has been receiving a stable dose of an acetylcholinesterase inhibitor
- •Patient has a MMSE score between 12 and 26
- •Patient has a MHIS score of less than or equal to 4
- •Females must be postmenopausal for at least two years or surgically sterile
- •Patient has an identified, reliable, caregiver who will support him/her to ensure compliance with treatment and will accompany them to each outpatient visit
排除标准
- •Patient is living in a nursing home
- •Patient has a history of any significant neurologic disease other than Alzheimer's disease
- •Patient has any uncontrolled medical illness
- •Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence
研究组 & 干预措施
A
Experimental
干预措施: ABT-089 (Drug)
B
Experimental
干预措施: ABT-089 (Drug)
C
Experimental
干预措施: ABT-089 (Drug)
D
Experimental
干预措施: ABT-089 (Drug)
E
Experimental
干预措施: ABT-089 (Drug)
F
Experimental
干预措施: ABT-089 (Drug)
G
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Baseline to Final Evaluation
次要结局
- Pharmacokinetics (how the body handles the study drug)(Baseline to Final Evaluation)
- Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)(Baseline to Final Evaluation)
研究者
相似试验
已完成
2 期
A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity DisorderNCT00528697AbbVie (prior sponsor, Abbott)278
已完成
2 期
Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity DisorderNCT00640419AbbVie (prior sponsor, Abbott)121
已完成
2 期
Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity DisorderNCT00640185AbbVie (prior sponsor, Abbott)160
已完成
2 期
Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01137526AbbVie (prior sponsor, Abbott)267
已完成
2 期
A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity DisorderNCT00391729Abbott221