NCT01766336终止2 期
A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Treatment Emergent Adverse Events
研究概览
简要总结
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
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
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete Week 12 visit of AG201
- •Both patient and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests
排除标准
- •Is currently using any other investigational or experimental drugs or devices
- •Has significant worsening of medical conditions or dementia such that it may preclude completion of this safety extension study
研究组 & 干预措施
Group 1 ELND005/ELND005
Experimental
Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks.
干预措施: Group 1 ELND005 (Drug)
Group 2 PLACEBO/ELND005
Experimental
Patients who received placebo during Study AG201 will receive ELND005 at the same dosing regimen as the active group in Study AG201 for 36 weeks.
干预措施: Group 2 ELND005 (Drug)
结局指标
主要结局
Number of Participants Experiencing Treatment Emergent Adverse Events
时间窗: 36 weeks
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
次要结局
未报告次要终点
研究者
研究点 (1)
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