A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of V950 Formulated on Aluminum-Containing Adjuvant With or Without ISCOMATRIX™ in Patients With Alzheimer Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Number of Participants Who Experienced at Least One Adverse Event
研究概览
简要总结
The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has mild to moderate Alzheimer Disease
- •Women cannot be able to get pregnant
- •Patient has a reliable caregiver, who will attend all visits and answer questions about the patient
排除标准
- •Patient lives in a nursing home or facility
- •Patient has another neurological or neurodegenerative disorder
- •Patient has a history of stroke
- •Patient uses illicit drugs or has a history of drug/alcohol abuse
- •Patient has received blood or blood derived products within 6 months
结局指标
主要结局
Number of Participants Who Experienced at Least One Adverse Event
时间窗: Up to 4 years after first dose of vaccine
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7
时间窗: Month 7
The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies
时间窗: Baseline and Month 7
The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
时间窗: Up to 6 months after first dose of vaccine
This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
次要结局
未报告次要终点