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

Sponsor
Allon Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT00404014
Collaborator
(none)
234
Enrollment
28
Locations
2
Arms
22
Duration (Months)
8.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
234 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, 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.
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  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. [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 Outcome Measures

  1. The safety profile of AL-208 in subjects undergoing CABG surgery [14 days]

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

  2. The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery [14 days]

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

  3. Concentration of AL-208 in plasma in subjects undergoing CABG surgery [14 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 79 Years
Sexes Eligible for Study:
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:

  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

Locations

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

Sponsors and Collaborators

  • Allon Therapeutics

Investigators

  • Study Director: Elena Matthews, MD, Medical Monitor on behalf of Allon Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Allon Therapeutics
ClinicalTrials.gov Identifier:
NCT00404014
Other Study ID Numbers:
  • AL 208-201
First Posted:
Nov 27, 2006
Last Update Posted:
Oct 24, 2012
Last Verified:
Oct 1, 2012
Keywords provided by Allon Therapeutics
MCI following CABG surgery
Additional relevant MeSH terms:
Cognitive Dysfunction

Study Results

No Results Posted as of Oct 24, 2012