NCT01397578已完成2 期
A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 29
- 主要终点
- Change in brain amyloid load as assessed by amyloid PET imaging
研究概览
简要总结
This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria
- •Mini-Mental State Examination (MMSE) score of 18-26 points at screening
- •Geriatric Depression Scale (GDS-15) score of < 6
- •Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)
- •For patients currently receiving treatment with approved AD treatments (AChE inhibitors or memantine): Treatment initiated and continued for at least the last 3 months prior to randomization, at a stable dose for at least the last 2 months prior to randomization
排除标准
- •Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care
- •History or presence of clinically evident vascular disease potentially affecting the brain (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation)
- •History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (e.g., cerebral contusion)
- •Hospitalization within 4 weeks prior to screening
- •Previous treatment with MABT5102A or any other therapeutic that targets Abeta
- •Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed
研究组 & 干预措施
Part 1: Subcutaneous cohort exp
Experimental
干预措施: MABT5102A (Drug)
Part 2: Intravenous cohort exp
Experimental
干预措施: MABT5102A (Drug)
Part 1: Subcutaneous cohort
Placebo Comparator
Repeating subcutaneous injection
干预措施: placebo (Drug)
Part 2: Intravenous cohort
Placebo Comparator
Repeating intravenous injection
干预措施: placebo (Drug)
结局指标
主要结局
Change in brain amyloid load as assessed by amyloid PET imaging
时间窗: Baseline to Week 69
次要结局
- Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging(Baseline to Week 69)
- Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease(Baseline to Week 69)
- Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score(Baseline to Week 73)
研究者
研究点 (29)
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