A Phaseiia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 40
- 试验地点
- 20
- 主要终点
- Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
研究概览
简要总结
The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 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 Status Exam (MMSE) of 16-26
排除标准
- •Significant Neurological Disease
- •Major Psychiatric Disorder
- •Clinically significant systemic illness
研究组 & 干预措施
PBS
Placebo, IM injection, Day 1, month 3, 6, 9, 12
干预措施: PBS (Other)
结局指标
主要结局
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
时间窗: Baseline up to 24 months
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
时间窗: Baseline up to 24 months
Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Number of Participants With Abnormalities in Neurological Examination
时间窗: Baseline up to 24 months
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.
次要结局
- Anti-a-beta IgG Titer at Specified Visits(Baseline up to 24 months)
- Anti-a-beta IgM Titer at Specified Visits(Baseline up to 24 months)