NCT00693004终止2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of PRX-03140 as Monotherapy in Subjects With Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 236
- 试验地点
- 33
- 主要终点
- Alzheimer's Disease Assessment Scale-Cognitive subscale.
研究概览
简要总结
A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment period and an optional 3-month extension period.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or Women with a clinical diagnosis of Probable AD
- •MMSE score 16 to 24 inclusive
- •Age >50 and <90 years
- •Brain CT or MRI scan Consistent with a primary diagnosis of AD within 12 months
- •Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits)
- •No history or evidence of any other CNS disorder that could be interpreted as a cause of dementia
- •No diagnosis of vascular dementia
- •No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. Subjects with major depressive disorder on a stable dose of an antidepressant for >6 months may be eligible
- •No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or abnormalities in thyroid function
- •No cognitive rehabilitation within 6 months of the study
- •Subject has a regular caregiver willing to attend all study visits
- •Signed informed consent by the subject (and legal guardian, if applicable)
排除标准
- •No history of drug or alcohol abuse
- •No clinically significant laboratory abnormalities or medical history
- •No investigational drug within 30 days of Randomization
- •Intolerance or allergy to cholinesterase inhibitors
- •Cannot have been on cholinesterase inhibitors for AD for > 2 years
- •If have been on cholinesterase inhibitors for < 2 years, must have been discontinued >= 2 months prior to randomization
- •Cannot have received memantine within 2 months
- •No clinically significant ECG abnormalities prior to randomization
- •No history of uncontrolled seizure disorder within 12 months
- •Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
- •No history of malignancy within 3 years of randomization
- •Women cannot be pregnant or breastfeeding
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
PRX-03140
Experimental
干预措施: PRX-03140 (Drug)
donepezil
Active Comparator
干预措施: Donepezil (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale-Cognitive subscale.
次要结局
未报告次要终点
研究者
研究点 (33)
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