Full Text View
Tabular View
No Study Results Posted
Related Studies
Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery
This study has been completed.
First Received: November 24, 2006   Last Updated: September 11, 2008   History of Changes
Sponsored by: Allon Therapeutics
Information provided by: Allon Therapeutics
ClinicalTrials.gov Identifier: NCT00404014
  Purpose

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

Condition Intervention Phase
Mild Cognitive Impairment
Drug: AL-208
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study Designed to Evaluate the Safety, Tolerability, and Effect of a Single, Rising Dose of Intravenous AL-208, Followed by a Placebo-Controlled, Double-Blind, Parallel-Group Evaluation of a Single Dose of AL-208, on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery.

Resource links provided by NLM:


Further study details as provided by Allon Therapeutics:

Estimated Enrollment: 234
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404014

  Show 29 Study Locations
Sponsors and Collaborators
Allon Therapeutics
Investigators
Study Director: Elena Matthews, MD Medical Monitor on behalf of Allon Therapeutics
  More Information

No publications provided

Responsible Party: Allon Therapeutics Inc. ( Director, Clinical Operations )
Study ID Numbers: AL 208-201
Study First Received: November 24, 2006
Last Updated: September 11, 2008
ClinicalTrials.gov Identifier: NCT00404014     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Allon Therapeutics:
MCI following CABG surgery

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cognition Disorders

ClinicalTrials.gov processed this record on September 03, 2009