Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery
NCT ID: NCT00404014
Last Updated: 2012-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
234 participants
INTERVENTIONAL
2006-08-31
2008-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AL-208
1 dose of 300 mg
AL-208
1 dose of 300 mg
Placebo
Placebo
1 dose of placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AL-208
1 dose of 300 mg
Placebo
1 dose of placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
50 Years
79 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allon Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elena Matthews, MD
Role: STUDY_DIRECTOR
Medical Monitor on behalf of Allon Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Multicare Health Systems
Tacoma, Washington, United States
London health Sciences Centre
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AL 208-201
Identifier Type: -
Identifier Source: org_study_id