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CompletedNCT00404014Updated Oct 24, 2012

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

A Phase 2 interventional study of AL-208 and Placebo in Mild Cognitive Impairment, sponsored by Allon Therapeutics. Completed at 28 sites in 2 countries. Open to participants aged 50 Years to 79 Years. Per ClinicalTrials.gov, last updated 2012-10-24.

Sponsored by Allon Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
50 Years to 79 Years
Sex
All
01

Study 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

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • MCI following CABG surgery
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 234 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Allon Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 79 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
234 participants (actual)

Study arms

  • Active comparator
    AL-208

    1 dose of 300 mg

    Drug: AL-208

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugAL-208

    1 dose of 300 mg

  • DrugPlacebo

    1 dose of placebo

06

What researchers measure

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.

    Time frame: 14 days

Secondary outcomes

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

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

    Time frame: 14 days

  2. The effect of treatment with AL-208 on postoperative personality changes 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

  3. Concentration of AL-208 in plasma in subjects undergoing CABG surgery

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

    Time frame: 14 days

07

Study locations

28 sites
  • Physicians Clinical Research Corp.
    Laguna Hills, California 92653, United States
  • Sacramento Heart and Vascular Research Center
    Sacramento, California 95825, United States
  • Jacksonville Center for Clinical Research
    Jacksonville, Florida 32216, United States
  • Miami Research Associates
    South Miami, Florida 33143, United States
  • Piedmont Hospital Research Institute
    Atlanta, Georgia 30309, United States
  • The Atlanta Heart and Vascular Research Group
    Atlanta, Georgia 30342, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Chicago Heart Institute and Vein Clinic
    Elk Grove Village, Illinois 60007, United States
  • Illinois Heart and Vascular Foundation
    Hindsdale, Illinois 60521, United States
  • Indiana/Ohio Heart Cardiothoracic and Vascular Surgeons
    Ft. Wayne, Indiana 46804, United States
  • Brigham & Women's Hospital
    Boston, Massachusetts 02115, United States
  • Cardiothoracic Associates
    Flint, Michigan 48532, United States
  • NYU Medical Center
    New York, New York 10016, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Carolina Cardiovascular Surgical Associates, PA
    Raleigh, North Carolina 27610, United States
  • Memory Assessment and Research Services
    Wilmington, North Carolina 28405, United States
  • St. Vincent Mary Medical Center
    Toledo, Ohio 43608, United States
  • Tulsa Clinical Resesarch, LLC
    Tulsa, Oklahoma 74104-5428, United States
  • Consultants in Cardiovascular Diseases Inc.
    Erie, Pennsylvania 16502, United States
  • Clinical Research Solutions, PC
    Knoxville, Tennessee 37920, United States
  • Vanderbilt University
    Nashville, Tennessee 37212, United States
  • Clinical Cardiovascular Research Center
    Dallas, Texas 75226, United States
  • St. Luke's Episcopal Hospital
    Houston, Texas 77030, United States
  • Inova Fairfax Hospital
    Falls Church, Virginia 22042, United States
  • Cardiac and Thoracic Surgical Associates, Ltd.
    Mechanicsville, Virginia 23116, United States
  • Multicare Health Systems
    Tacoma, Washington 98415, United States
  • London health Sciences Centre
    London, Ontario N6A5A5, Canada
  • Toronto General Hospital
    Toronto, Ontario M5G2C4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00404014
Lead sponsor
Allon Therapeutics
Responsible party
Sponsor
First posted
Nov 27, 2006
Start date
Aug 2006
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Oct 24, 2012

Study contacts

Elena Matthews, MD
study director · Medical Monitor on behalf of Allon Therapeutics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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