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

October 18, 2012 updated by: Allon Therapeutics

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.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
1 dose of placebo
Active Comparator: AL-208
1 dose of 300 mg
Drug: AL-208
1 dose of 300 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The safety profile of AL-208 in subjects undergoing CABG surgery
Time Frame: 14 days
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
Time Frame: 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
Time Frame: 14 days
Concentration of AL-208 in plasma in subjects undergoing CABG surgery
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allon Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elena Matthews, MD, Medical Monitor on behalf of Allon Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AL 208-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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