A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel-group, Multicenter, Phase IIa Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311) in Patients With Mild Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the secondary endpoint.
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
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild Alzheimer's Disease
- •Mini-Mental State Examination (MMSE) scores between 20 and 26 (inclusive)
- •Clinical dementia rating (CDR) scores of 0.5 or 1
- •Other inclusion criteria apply
排除标准
- •Clinically significant neurological disease other than Alzheimer's disease
- •Major psychiatric disorder
- •Severe systemic disease
- •Serious adverse reactions to any vaccine
- •Other exclusion criteria apply
研究组 & 干预措施
3 priming doses followed by 4 boosters
Subjects will receive 7 doses of UB-311.
干预措施: UB-311 (Biological)
3 priming doses followed by 2 boosters
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
干预措施: UB-311 (Biological)
3 priming doses followed by 2 boosters
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
干预措施: Placebo (Drug)
Placebo
Subjects will receive 7 doses of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events
时间窗: 78 weeks
Safety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs.
次要结局
未报告次要终点