Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,457
- 试验地点
- 1
- 主要终点
- Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
研究概览
简要总结
This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).
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
- None
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
- •Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
- •Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
- •Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
- •Must have good vein access to administer infusions
- •Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO
排除标准
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- •Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study
研究组 & 干预措施
Solanezumab
干预措施: Solanezumab (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
时间窗: Baseline through Week 104
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
次要结局
- Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)(Baseline, Week 104)
- Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)(Baseline, Week 104)
- Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels(Baseline, Week 52)
- Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)(Baseline, Week 104)
- Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)(Baseline, Week 104)
- Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)(Baseline, Week 104)
- Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)(Baseline, Week 104)
- Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)(Baseline, Week 104)
- Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)(Baseline, Week 104)
- Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)(Baseline, Week 104)
- Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours(Baseline, Week 104)
- Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease(Baseline, Week 104)