A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 53
- 试验地点
- 22
- 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 purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.
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
- None
入排标准
- 年龄范围
- 52 Years 至 87 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
- •Screening brain MRI scan is consistent with the diagnosis of AD.
- •MMSE score 10 and above.
排除标准
- •Significant neurological diseases other than AD.
- •Brain MRI evidence of vasogenic edema during the preceding studies.
- •Clinically significant illness.
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 radiologists.
Number of Treatment Emergent Adverse Events (AEs) by Severity
时间窗: Baseline up to 24 months
Number of mild, moderate, and 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 of the preceding studies through 24 months of this study
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.
次要结局
未报告次要终点