NCT00998764终止3 期
A Phase 3 Extension, Multicenter, Long Term Safety And Tolerability Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E 4 Carriers And Participated In Study 3133k1-3001-us Or Study 3133k1-3001-ww.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 494
- 试验地点
- 180
- 主要终点
- Number of Participants Reporting a Serious Adverse Event
研究概览
简要总结
The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.
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
- 51 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has completed study 3133K1-3001 (Week 78) and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease
- •Mini-Mental Status Examination (MMSE) >=10 at screening
- •Caregiver able to attend all clinic visits with subject
排除标准
- •Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
- •Any significant brain MRI abnormality.
- •Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening
研究组 & 干预措施
Bapineuzumab 0.5 mg/kg
Experimental
干预措施: Bapineuzumab 0.5 mg/kg (Drug)
结局指标
主要结局
Number of Participants Reporting a Serious Adverse Event
时间窗: Up to Week 195
Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.
次要结局
- Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78(Base Study Baseline, Weeks 13, 26, 39, 52 and 78)
- Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.(Base Study Baseline, Weeks 13, 26, 39, 52 and 78)
- Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.(Base Study Baseline, Weeks 13, 26, 39, 52 and 78)
- Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.(Base Study Baseline, Weeks 26, 52 and 78)
- Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.(Base Study Baseline, Weeks 13, 26, 39, 52 and 78)
- Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.(Base Study Baseline, Weeks 6, 19, 32, 45 and 78)
- Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.(Base Study Baseline, Weeks 26, 52 and 78)
- Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.(Base Study Baseline, Weeks 6, 19, 32, 45 and 78)
研究者
研究点 (180)
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