NCT00329082已完成2 期
LY2062430: Multiple-Dose Safety in Subjects With Mild-to-Moderate Alzheimer's Disease and Single-Dose Safety in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
To study the safety of LY2062430 in patients with mild-to-moderate Alzheimer's disease and in healthy volunteers.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 50 years of age and diagnosed with mild to moderate Alzheimer's disease or healthy volunteers
- •fluent in reading and speaking English
- •AD patients must have a reliable study partner who will be in frequent contact with the patient and comply with protocol requirements
- •AD patients who have received AChEIs or memantine for at least 4 months and on stable therapy for at least 2 months prior to starting study drug
排除标准
- •Have a history of serious infectious disease affecting the brain, head trauma, cancer, drug or alcohol abuse in the past 5 years
- •Have serious or uncontrolled health problems or laboratory tests
- •Multiple or severe drug allergies
- •Prior participation in an active immunization study
研究组 & 干预措施
3
Experimental
干预措施: LY2062430 (Drug)
1
Experimental
干预措施: LY2062430 (Drug)
2
Experimental
干预措施: LY2062430 (Drug)
4
Experimental
干预措施: LY2062430 (Drug)
5
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 1 year
次要结局
- To determine the plasma pharmacokinetics of LY2062430(1 year)
- To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations(1 year)
- To evaluate the changes in thinking and memory(1 year)
研究者
研究点 (1)
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