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

Completed · Phase 2 · Has a placebo group

Conditions studied: Mild Cognitive Impairment

In brief

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

Key facts

Study ID

NCT00404014

Run by

Allon Therapeutics

People needed

234

Starts

2006-08-01

Expected to finish

2008-06-01

Last updated by the study team

2012-10-24

Who can join

Age: 50 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Cardiac and Thoracic Surgical Associates, Ltd. — Mechanicsville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.