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

NCT00404014 | Completed Phase 2

• 1 other identifier: AL 208-201
• Study Type: interventional
• Target: 234
• Locations: 2 countries
• Sites: 28

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

Conditions

Mild Cognitive Impairment

Keywords

MCI following CABG surgery

Outcome Measures

Primary Outcomes (1)

• 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 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.

  14 days

Secondary Outcomes (3)

• The safety profile of AL-208 in subjects undergoing CABG surgery

  14 days

• The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery

  14 days

• Concentration of AL-208 in plasma in subjects undergoing CABG surgery

  14 days

Study Arms (2)

AL-208

ACTIVE COMPARATOR

1 dose of 300 mg

Drug: AL-208

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AL-208 DRUG

1 dose of 300 mg

AL-208

Placebo DRUG

1 dose of placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Allon Therapeutics: lead

Study Sites (28)

Physicians Clinical Research Corp.

Laguna Hills, California, 92653, United States

Location

Sacramento Heart and Vascular Research Center

Sacramento, California, 95825, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Piedmont Hospital Research Institute

Atlanta, Georgia, 30309, United States

Location

The Atlanta Heart and Vascular Research Group

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Chicago Heart Institute and Vein Clinic

Elk Grove Village, Illinois, 60007, United States

Location

Illinois Heart and Vascular Foundation

Hindsdale, Illinois, 60521, United States

Location

Indiana/Ohio Heart Cardiothoracic and Vascular Surgeons

Fort Wayne, Indiana, 46804, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Cardiothoracic Associates

Flint, Michigan, 48532, United States

Location

NYU Medical Center

New York, New York, 10016, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Carolina Cardiovascular Surgical Associates, PA

Raleigh, North Carolina, 27610, United States

Location

Memory Assessment and Research Services

Wilmington, North Carolina, 28405, United States

Location

St. Vincent Mary Medical Center

Toledo, Ohio, 43608, United States

Location

Tulsa Clinical Resesarch, LLC

Tulsa, Oklahoma, 74104-5428, United States

Location

Consultants in Cardiovascular Diseases Inc.

Erie, Pennsylvania, 16502, United States

Location

Clinical Research Solutions, PC

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Clinical Cardiovascular Research Center

Dallas, Texas, 75226, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Cardiac and Thoracic Surgical Associates, Ltd.

Mechanicsville, Virginia, 23116, United States

Location

Multicare Health Systems

Tacoma, Washington, 98415, United States

Location

London health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

Location

Related Publications (1)

• Gozes I, Blatt J, Guz LS. Systemic davunetide provides sex-specific neuroprotection during Coronary Artery Bypass Grafting (CABG). Transl Psychiatry. 2025 Oct 31;15(1):454. doi: 10.1038/s41398-025-03675-y.

  PMID: 41173865 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

davunetide

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Elena Matthews, MD

  Medical Monitor on behalf of Allon Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2006
• First Posted: November 27, 2006
• Study Start: August 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

US (26); CA (2)