An Extension Study of a Phase IIa Study in Patients With Mild Alzheimer's Disease to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
研究概览
简要总结
To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study (NCT02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a 12-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who participated in V203-AD trial without major safety concerns;
- •Stable doses of permitted medications for 3 months before screening;
- •With a caregiver;
- •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 boosters
Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
干预措施: UB-311 (Biological)
3 boosters
Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
干预措施: Placebo (Drug)
3 priming doses followed by 2 boosters
Subjects will receive 5 doses of UB-311.
干预措施: UB-311 (Biological)
结局指标
主要结局
Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
时间窗: Overall Study Duration/Early Termination, over an average study duration of 326 days
For the immunogenicity assessment of the investigational product, UB-311, the level of anti-Aβ antibodies in the serum samples will be measured by a validated enzyme immunoassay manufactured by United Biomedical, Inc. (UBI). The level of anti-Aβ antibodies is assessed at every visit throughout the study period.
The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).
时间窗: Overall Study Duration/Early Termination, over an average study duration of 326 days
Summary of Treatment Emergent Adverse Events (TEAEs), based on reported adverse events and other safety information including local tolerability at injection site, MRI, vital signs, physical examination, 12-lead ECG and laboratory tests.
次要结局
未报告次要终点