Status:
COMPLETED
Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery
Lead Sponsor:
Allon Therapeutics
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
50-79 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00404014
Start Date
August 1 2006
End Date
June 1 2008
Last Update
October 24 2012
Active Locations (28)
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1
Physicians Clinical Research Corp.
Laguna Hills, California, United States, 92653
2
Sacramento Heart and Vascular Research Center
Sacramento, California, United States, 95825
3
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
4
Miami Research Associates
South Miami, Florida, United States, 33143