A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 63
- 试验地点
- 40
- 主要终点
- Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)
研究概览
简要总结
This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concern about a change in cognition expressed by the subject or by an informant that knows the subject well
- •Mini-Mental State Examination (MMSE) score ≥ 25
- •Global Clinical Dementia Rating = 0.
- •General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening.
- •Amyloid burden detected on screening brain PET scan.
- •Other inclusion criteria apply.
排除标准
- •Significant neurological disease other than early Alzheimer's disease
- •Major psychiatric disorder or symptom
- •Contraindication to undergo brain MRI
- •Unstable medical conditions
- •Other exclusion criteria apply
研究组 & 干预措施
Placebo- Phosphate buffered saline (PBS)
干预措施: Placebo- Phosphate buffered saline (PBS) (Other)
ACC-001 3 μg/ QS-21 50 μg
干预措施: ACC-001 3 μg/ QS-21 50 μg (Biological)
ACC-001 10 μg/ QS-21 50 μg
干预措施: ACC-001 10 μg/ QS-21 50 μg (Biological)
结局指标
主要结局
Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)
时间窗: 104 weeks
Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline.
次要结局
未报告次要终点