DRUG
AL-208
1 dose of 300 mg
Status
Completed
Phase
Phase 2
Enrollment
234
Locations
28
Results
Not posted
Publications
1
Study 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
Interventions
DRUG
1 dose of 300 mg
DRUG
1 dose of placebo
Timeline
First posted
Nov 27, 2006
Study start
Aug 2006
Primary completion
Jun 2008
Study completion
Jun 2008
Results posted
Not reported
Registry updated
Oct 24, 2012
Outcomes
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.
Time frame · 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.
The safety profile of AL-208 in subjects undergoing CABG surgery
Time frame · 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
Time frame · 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
Time frame · 14 days
Concentration of AL-208 in plasma in subjects undergoing CABG surgery
Eligibility
Inclusion Criteria: 1. Males and females (of non-childbearing potential), 50 to 79 years of age. 2. Undergoing CABG surgery with the use of extracorporeal circulation. 3. Willing and able to complete cognitive testing. 4. Score \< 16 on the Center for Epidemiological Studies in Depression scale (CES-D). 5. Score \> or = 28 on the Mini-Mental State Examination (MMSE). 6. Willing and able to provide informed consent to participate in this study 7. Fluency in written and spoken English. Exclusion Criteria: 1. 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. 2. History of stroke or other significant neurological disorder 3. Transient ischemic attack (TIA) with ongoing cognitive sequelae 4. Chronic atrial fibrillation or uncontrolled atrial fibrillation prior to surgery 5. Myocardial infarction (MI) within the last 8 weeks and/or previous history of more than 3 MIs 6. History of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes \> 2.5 x upper limit or normal (ULN) at screening). 7. History of renal dysfunction with ongoing sequelae (including but not limited to creatinine value \> 2.5 mg/dL at screening). 8. Known active alcohol or drug abuse. 9. Concurrent use of prescription medications known to enhance memory 10. General anesthesia (defined as anesthesia requiring intubation or ventilatory support) within 3 months prior to randomization. 11. Cardiopulmonary bypass or thoracotomy within 2 years prior to randomization. 12. Undergoing valvular repair or replacement during scheduled CABG surgery. 13. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy. 14. Decompensating congestive heart disease 15. Subjects on immunosuppressive drugs, such as azathioprine, chemotherapeutic agents, mycophenolate, monoclonal antibodies, or more than 20 mg/day prednisone, within the previous 3 months 16. Receipt of any investigational agent or device within 30 days of screening.
Study locations
Canada · United States. Showing up to 24 locations stored in the fast local snapshot.
Physicians Clinical Research Corp.
Laguna Hills, California, United States
Sacramento Heart and Vascular Research Center
Sacramento, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Miami Research Associates
South Miami, Florida, 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
Chicago Heart Institute and Vein Clinic
Elk Grove Village, Illinois, United States
Illinois Heart and Vascular Foundation
Hindsdale, Illinois, United States
Indiana/Ohio Heart Cardiothoracic and Vascular Surgeons
Fort Wayne, Indiana, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Cardiothoracic Associates
Flint, Michigan, United States
NYU Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolina Cardiovascular Surgical Associates, PA
Raleigh, North Carolina, United States
Memory Assessment and Research Services
Wilmington, North Carolina, United States
St. Vincent Mary Medical Center
Toledo, Ohio, United States
Tulsa Clinical Resesarch, LLC
Tulsa, Oklahoma, United States
Consultants in Cardiovascular Diseases Inc.
Erie, Pennsylvania, United States
Clinical Research Solutions, PC
Knoxville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Clinical Cardiovascular Research Center
Dallas, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Publications
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