NCT00566397已完成2 期
A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants 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
- 发起方
- Pfizer
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI).
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.
- •Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization
排除标准
- •Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia.
- •Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations.
- •Evidence or history of diabetes mellitus Type 1 or Type
- •History or symptoms of autoimmune disorders.
研究组 & 干预措施
1
Experimental
干预措施: PF-04494700 (Drug)
2
Experimental
干预措施: PF-04494700 (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI).
时间窗: 18 Month
Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment.
时间窗: 18 Month
次要结局
- Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints(18 Month)
- Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET)(18 Month)
- Evaluate the potential dose response of PF 04494700(18 Month)
研究者
研究点 (1)
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