Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery

Inclusion criteria

• 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.

Exclusion criteria

• 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.