NCT00384423已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study to Assess the Short-Term Effects of PRX-03140 Alone and in Combination With Donepezil in Subjects With Mild Alzheimer's Disease.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 34
- 主要终点
- Safety and tolerability of PRX-03140 during 2 weeks of treatment.
研究概览
简要总结
This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once daily for 14 days in subjects with mild Alzheimer's Disease who are using a stable, well-tolerated 10 mg dose of Aricept (donepezil) but continue to experience worsening AD symptoms.
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
- Double
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 60 years old.
- •On a stable 10 mg dose of Aricept for at least 90 days and able to take it in the morning.
- •Diagnosis of probable Alzheimer's Disease.
- •Mild dementia.
- •You or your authorized representative provide voluntary written informed consent.
- •Not pregnant, planning a pregnancy, or capable of becoming pregnant.
排除标准
- •Any other medical condition which, in the opinion of the Investigator, would jeopardize your safety, impact the validity of the study results, or interfere with your ability to complete the study according to the protocol.
- •Intolerance to Aricept.
- •Dementia other than Alzheimer's type.
- •Parkinson's Disease.
- •History of seizure or epilepsy.
- •History of stroke.
- •Participation in another research study within last 30 days.
- •Enrollment in any previous research study testing PRX-
- •Use of prescription cognitive enhancing medications (except Aricept) or MAO inhibitors within last 4 weeks.
- •Use of tobacco products within last 4 weeks.
- •Positive blood screen for Hepatitis B surface antigen or Hepatitis C antibody.
- •Positive urine screen for alcohol or drugs of abuse or history of drug or alcohol abuse within last 6 months.
- •Major surgery within last 4 weeks.
结局指标
主要结局
Safety and tolerability of PRX-03140 during 2 weeks of treatment.
Electroencephalogram (EEG) changes through 14 days of treatment.
次要结局
- Changes in cognition after 2 weeks of treatment.
- Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.
研究者
研究点 (34)
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