Trial record 4 of 5 for:    davunetide

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allon Therapeutics
ClinicalTrials.gov Identifier:
NCT00404014
First received: November 24, 2006
Last updated: October 18, 2012
Last verified: October 2012
  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
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The safety profile of AL-208 in subjects undergoing CABG surgery [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Concentration of AL-208 in plasma in subjects undergoing CABG surgery


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)
Arms Assigned Interventions
Active Comparator: AL-208
1 dose of 300 mg
Drug: AL-208
1 dose of 300 mg
Placebo Comparator: Placebo Drug: Placebo
1 dose of placebo

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 28 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
ClinicalTrials.gov Identifier: NCT00404014     History of Changes
Other Study ID Numbers: AL 208-201
Study First Received: November 24, 2006
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Allon Therapeutics:
MCI following CABG surgery

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

ClinicalTrials.gov processed this record on July 28, 2015