A Phase 2, Multi-Center, Double-Blinded, Placebo-Controlled Safety And Efficacy Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.
研究概览
简要总结
The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild-to-Moderate Alzheimer's disease
- •MMSE score 10-24 inclusive
排除标准
- •Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days
- •Complication of other causes of dementia
研究组 & 干预措施
Placebo
Placebo three times daily for 6 months
干预措施: Placebo (Drug)
PF-01913539 5 mg three times daily
PF-01913539 5 mg three times daily for 6 months
干预措施: PF-01913539 5 mg (Drug)
PF-01913539 20 mg three times daily
PF-01913539 20 mg three times daily for 6 months
干预措施: PF-01913539 5 mg (Drug)
结局指标
主要结局
Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.
时间窗: 26 weeks
Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input
时间窗: 26 weeks
次要结局
- Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.(12, 26 weeks)
- Mean change in Neuropsychiatric Inventory (NPI) score from baseline.(12, 26 weeks)
- Mean change in Mini-Mental State Examination (MMSE) score from baseline.(6, 12, 18, 26 weeks)
- Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.(12, 26 weeks)
- Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis).(12, 26 weeks)
- Population PK parameters (CL/F, V/F, etc.)(26 weeks)