Current partner codePEPTIDESDE
NCT00404014·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

234

Locations

28

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

AL-208

1 dose of 300 mg

DRUG

Placebo

1 dose of placebo

Timeline

From registration to results.

  1. First posted

    Nov 27, 2006

  2. Study start

    Aug 2006

  3. Primary completion

    Jun 2008

  4. Study completion

    Jun 2008

  5. Results posted

    Not reported

  6. Registry updated

    Oct 24, 2012

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
50 Years
Maximum age
79 Years
Sex
ALL
Healthy volunteers
No

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

28 registered sites.

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

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Put the record in context.

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