跳至主要内容
临床试验/NCT00934050
NCT00934050已完成2 期

A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease

OPKO Health, Inc.38 个研究点 分布在 2 个国家目标入组 103 人开始时间: 2009年6月最近更新:
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
103
试验地点
38
主要终点
Treatment Emergent Adverse Events (TEAEs)

研究概览

简要总结

The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication.

排除标准

  • Subject has no new medical contraindications to continued participation in the study.

研究组 & 干预措施

ELND005

Experimental

干预措施: ELND005 (scyllo-inositol) (Drug)

结局指标

主要结局

Treatment Emergent Adverse Events (TEAEs)

时间窗: 12 months

Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (38)

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