NCT00890890终止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 Prodromal Alzheimer's Disease
Bristol-Myers Squibb51 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2009年5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
- 终止
- 发起方
- 入组人数
- 263
- 试验地点
- 51
- 主要终点
- Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
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 Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.
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
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)
- •Memory complaint by subject or study partner
- •CSF aβ42 levels < 200pg/mL or Total Tau/aβ42 ratio of ≥ 0.39
- •Score of ≤4 on the Modified Hachinski Ischemia Scale
- •CT results consistent with Alzheimer's disease
- •Medically stable
- •6 years education
- •Reliable study partner
- •Must be able to swallow capsules
排除标准
- •Premenopausal women
- •DSM-IV diagnosis of Dementia 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
- •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
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Avagacestat (50 mg)
Experimental
干预措施: Avagacestat (Drug)
结局指标
主要结局
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
时间窗: Avagacestat-treated patients will have a 24 week post treatment skin examination by a dermatologist
次要结局
- Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia(Baseline (Week 0), Week 2 (optional), Week 24 and Week 104)
研究者
研究点 (51)
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