NCT00141661已完成2 期
A Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study in Subjects With Mild to Moderate Dementia of the Alzheimer's Type to Evaluate the Safety and Tolerability of Two 10-Week Dose Regimens of Orally-Administered PF-04494700
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
- 67
- 试验地点
- 1
- 主要终点
- Safety Measures include Adverse Events
研究概览
简要总结
A 10-week safety and tolerability study of a potential treatment for 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
- •Diagnosis of probably Alzheimer's disease for at least 1 year.
- •Mini Mental State Exam (MMSE) score between 12-26 at screening.
- •Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.
排除标准
- •Current evidence of a neurological or psychiatric illness that could contribute to dementia.
- •Living alone.
- •Poorly controlled high blood pressure.
研究组 & 干预措施
Low Dose Arm
Experimental
干预措施: PF-04494700 - Low Dose Arm (Drug)
High Dose Arm
Experimental
干预措施: PF-04494700 - High Dose Arm (Drug)
Placebo Control
Placebo Comparator
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Safety Measures include Adverse Events
时间窗: Every Visit
Laboratory Tests
时间窗: Every Office Visit
12-Lead Electrocardiogram
时间窗: Every Office Visit
24-Hour 12-Lead Serial ECGs
时间窗: Baseline, Study End
次要结局
- Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta(Baseline, Visit 5, Study End)
- Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL(Screening Visit, Baseline, Study End)
- Pharmacokinetic Profile(Baseline and Every Office Visit)
研究者
研究点 (1)
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