Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery
- Registration Number
- NCT00404014
- Lead Sponsor
- Allon Therapeutics
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AL-208 AL-208 1 dose of 300 mg Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method The safety profile of AL-208 in subjects undergoing CABG surgery 14 days The safety profile of AL-208 in subjects undergoing CABG surgery
The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery 14 days The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery
Concentration of AL-208 in plasma in subjects undergoing CABG surgery 14 days Concentration of AL-208 in plasma in subjects undergoing CABG surgery
Trial Locations
- Locations (28)
Cardiac and Thoracic Surgical Associates, Ltd.
🇺🇸Mechanicsville, Virginia, United States
Clinical Cardiovascular Research Center
🇺🇸Dallas, Texas, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
London health Sciences Centre
🇨🇦London, Ontario, Canada
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Piedmont Hospital Research Institute
🇺🇸Atlanta, Georgia, United States
The Atlanta Heart and Vascular Research Group
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Physicians Clinical Research Corp.
🇺🇸Laguna Hills, California, United States
Sacramento Heart and Vascular Research Center
🇺🇸Sacramento, California, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Chicago Heart Institute and Vein Clinic
🇺🇸Elk Grove Village, Illinois, United States
Cardiothoracic Associates
🇺🇸Flint, Michigan, United States
NYU Medical Center
🇺🇸New York, New York, United States
Illinois Heart and Vascular Foundation
🇺🇸Hindsdale, Illinois, United States
Indiana/Ohio Heart Cardiothoracic and Vascular Surgeons
🇺🇸Ft. Wayne, Indiana, United States
St. Vincent Mary Medical Center
🇺🇸Toledo, Ohio, United States
Memory Assessment and Research Services
🇺🇸Wilmington, North Carolina, United States
Consultants in Cardiovascular Diseases Inc.
🇺🇸Erie, Pennsylvania, United States
Carolina Cardiovascular Surgical Associates, PA
🇺🇸Raleigh, North Carolina, United States
Tulsa Clinical Resesarch, LLC
🇺🇸Tulsa, Oklahoma, United States
Multicare Health Systems
🇺🇸Tacoma, Washington, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Clinical Research Solutions, PC
🇺🇸Knoxville, Tennessee, United States