NCT00404014已完成2 期
A Phase II Study Designed to Evaluate the Safety, Tolerability, and Effect of a Single, Rising Dose of Intravenous AL-208, Followed by a Placebo-Controlled, Double-Blind, Parallel-Group Evaluation of a Single Dose of AL-208, on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery.
Allon Therapeutics28 个研究点 分布在 2 个国家目标入组 234 人开始时间: 2006年8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
- 234
- 试验地点
- 28
- 主要终点
- The primary objective of this study was to compare mild cognitive impairment in the AL-208 group with the placebo group at 14±3 days after coronary artery bypass graft (CABG) surgery.
研究概览
简要总结
The primary objective is to compare mild cognitive impairment in the AL-208 group with the placebo group at 14 + - 3 days after CABG surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females (of non-childbearing potential), 50 to 79 years of age.
- •Undergoing CABG surgery with the use of extracorporeal circulation.
- •Willing and able to complete cognitive testing.
- •Score < 16 on the Center for Epidemiological Studies in Depression scale (CES-D).
- •Score > or = 28 on the Mini-Mental State Examination (MMSE).
- •Willing and able to provide informed consent to participate in this study
- •Fluency in written and spoken English.
排除标准
- •Presence of any severe mental illness that could affect interpretation of efficacy data, such as schizophrenia or bipolar affective disorder; any untreated or unstable psychiatric condition including depressive disorder or anxiety disorder.
- •History of stroke or other significant neurological disorder
- •Transient ischemic attack (TIA) with ongoing cognitive sequelae
- •Chronic atrial fibrillation or uncontrolled atrial fibrillation prior to surgery
- •Myocardial infarction (MI) within the last 8 weeks and/or previous history of more than 3 MIs
- •History of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes > 2.5 x upper limit or normal (ULN) at screening).
- •History of renal dysfunction with ongoing sequelae (including but not limited to creatinine value > 2.5 mg/dL at screening).
- •Known active alcohol or drug abuse.
- •Concurrent use of prescription medications known to enhance memory
- •General anesthesia (defined as anesthesia requiring intubation or ventilatory support) within 3 months prior to randomization.
- •Cardiopulmonary bypass or thoracotomy within 2 years prior to randomization.
- •Undergoing valvular repair or replacement during scheduled CABG surgery.
- •Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy.
- •Decompensating congestive heart disease
- •Subjects on immunosuppressive drugs, such as azathioprine, chemotherapeutic agents, mycophenolate, monoclonal antibodies, or more than 20 mg/day prednisone, within the previous 3 months
- •Receipt of any investigational agent or device within 30 days of screening.
研究组 & 干预措施
AL-208
Active Comparator
1 dose of 300 mg
干预措施: AL-208 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The primary objective of this study was to compare mild cognitive impairment in the AL-208 group with the placebo group at 14±3 days after coronary artery bypass graft (CABG) surgery.
时间窗: 14 days
The primary objective of this study was to compare mild cognitive impairment in the AL-208 group with the placebo group at 14±3 days after coronary artery bypass graft (CABG) surgery.
次要结局
- The safety profile of AL-208 in subjects undergoing CABG surgery(14 days)
- The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery(14 days)
- Concentration of AL-208 in plasma in subjects undergoing CABG surgery(14 days)
研究者
研究点 (28)
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