NCT00965588已完成1 期
A Phase I, Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of the UBITh AD Immunotherapeutic Vaccine (UB 311) in Patients With Mild to Moderate Alzheimer's Disease
United Biomedical4 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2009年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- To evaluate safety and tolerability of the vaccine (UB 311).
研究概览
简要总结
The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.
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
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild to moderate Alzheimer's Disease
- •Mini-Mental State Examination (MMSE) 15-25
- •Other inclusion criteria apply
排除标准
- •Major psychiatric disorder
- •Severe systemic disease
- •Serious adverse reactions to any vaccine
- •Other exclusion criteria apply
结局指标
主要结局
To evaluate safety and tolerability of the vaccine (UB 311).
时间窗: Screen, treatment & follow-up: 28-30 weeks
次要结局
- To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).(Screen, treatment & follow-up: 28-30 weeks)
研究者
研究点 (4)
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