NCT00810147已完成2 期
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Mild to Moderate Alzheimer's Disease
Bristol-Myers Squibb36 个研究点 分布在 2 个国家目标入组 209 人开始时间: 2009年2月最近更新:
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
- 入组人数
- 209
- 试验地点
- 36
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and the course of any potential effects during a 12-week wash-out period
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Mild to Moderate Alzheimer's disease (MMSE 16-26)
- •6 Month cognitive decline
- •Stable marketed AD therapy x2 months or additional marketed AD therapy during study
- •Score of <=4 on the Modified Hachinski Ischemia Scale
- •CT results consistent with Alzheimer's disease
- •Medically stable
- •6 years education
- •Reliable study partner (caregiver)
- •Must be able to swallow capsules
排除标准
- •Premenopausal women
- •Dementia due to other causes than Alzheimer's disease
- •History of stroke
- •Immunocompromised
- •Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea or past GI surgery that would impact drug absorption
- •Unstable Vitamin B-12 deficiency
- •Hematologic or solid malignancy within 5 years
- •Geriatric Depression Scale >= 6
- •Unstable medical condition
- •Alcohol or drug abuse history with 12-months of study entry
- •Significant drug allergy
- •Alzheimer's disease modification experimental therapy with 12 months of study entry
- •Prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry
- •Any other experimental therapy with 30-days of study entry
研究组 & 干预措施
A1
Active Comparator
干预措施: BMS-708163 (Drug)
A2
Active Comparator
干预措施: BMS-708163 (Drug)
A3
Active Comparator
干预措施: BMS-708163 (Drug)
A4
Active Comparator
干预措施: BMS-708163 (Drug)
A5
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Events
时间窗: Weekly for the first 12-weeks of the 24-Week dosing period (Baseline-Week-12) and every 2 weeks during the second 12-weeks of the 24-Week dosing period (Weeks 14-24) and during the subsequent 12-week washout period (Weeks 28, 32, & 36)
次要结局
- Pharmacodynamics effects of the Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes(Baseline, Week 12, Week 24 and Week 36)
- Characterize Pharmacodynamics/Pharmacokinetics effects of the plasma exposure of BMS-708163 and variability in a population with Alzheimer's disease(Baseline, Week 12 and Week 24)
- Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale(Baseline, Week 12, Week 24 and Week 36)
- Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects(Baseline, Week 12 and Week 24)
- Pharmacodynamics effects of Cerebral Spinal Fluid(Baseline, Week 12 and Week 24)
- Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale(Baseline, Week 12, Week 24 and Week 36)
- Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes(Baseline, Week 12 and Week 24)
- Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data(Baseline, Week 12 and Week 24)
研究者
研究点 (36)
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