A Study Examining the Safety and Activity of Innate Immune System Stimulation With Leukine® (Sargramostim) to Reduce Brain Amyloid Load in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Sanofi
- 试验地点
- 1
- 主要终点
- Change from baseline in standardized uptake value ratio as measured by PET using florbetapir F18 (Amyvid)
研究概览
简要总结
Primary Objective:
To compare the effect of repeat doses of Leukine to placebo administered subcutaneously (SC) on established cortical amyloid load in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD).
Secondary Objective:
- To evaluate safety and tolerability of Leukine versus placebo.
- To explore the effect of Leukine versus placebo on cognitive performance.
- To collect biospecimens for future biomarker research.
详细描述
The total duration of study period per patient is up to 28 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Leukine
Administered SC in treatment cycles up to 24 weeks
Florbetapir administered for PET scans to examine baseline brain imaging pathology and changes on treatment.
干预措施: Sargramostim GZ402664 (Drug)
Leukine
Administered SC in treatment cycles up to 24 weeks
Florbetapir administered for PET scans to examine baseline brain imaging pathology and changes on treatment.
干预措施: Florbetapir F18 (Drug)
Placebo
Administered SC in treatment cycles up to 24 weeks
Florbetapir administered for PET scans to examine baseline brain imaging pathology and changes on treatment.
干预措施: Placebo (Drug)
Placebo
Administered SC in treatment cycles up to 24 weeks
Florbetapir administered for PET scans to examine baseline brain imaging pathology and changes on treatment.
干预措施: Florbetapir F18 (Drug)
结局指标
主要结局
Change from baseline in standardized uptake value ratio as measured by PET using florbetapir F18 (Amyvid)
时间窗: From baseline to Week 24
次要结局
- Number of patients experiencing treatment-emergent adverse events (TEAEs)(Week 24)
- Change from baseline in CSF analysis(Prior to first injection on Day 1 to serve as a baseline for any necessary follow-up, and optional assessment at Day 155)
- Measurement of antidrug antibody levels(At Days 1, 29, 57, 85, and 155)
- MRI to assess for emergence of amyloid related imaging abnormalities (ARIA)(At Screening and Days 43, 85, and 155)