An Open-Label Extension To The B1451006 Protocol To Evaluate The Safety And Efficacy Of Dimebon (Latrepirdine, PF-01913539) In Subjects With Moderate-To-Severe Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of dimebon in subjects with moderate-to-severe Alzheimer's Disease.
详细描述
This study was terminated on May 7, 2010 due to modification of the dimebon development plan, following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful completion of 6 months treatment in the previous B1451006 Phase 3 dimebon study
排除标准
- •Any major medical illness or unstable medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the ability to interpret study safety data
研究组 & 干预措施
Dimebon
干预措施: Dimebon tablet for oral administration (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Baseline up to 4 weeks after last dose of study treatment
An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
次要结局
- Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26(Baseline, Week 6, 12, 26)
- Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26(Baseline, Week 6, 12, 26)
- Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26(Baseline, Week 12, 26)
- Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26(Baseline, Week 6, 12, 26)
- Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26(Week 26)
- Change From Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) at Week 12 and 26(Baseline, Week 12, 26)
- Change From Baseline in European Quality of Life 5 Domain Scale (EQ-5D) at Week 12 and 16(Baseline, Week 12, 26)