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.

Allon Therapeutics28 sites in 2 countries234 target enrollmentAugust 2006

ConditionsMild Cognitive Impairment

InterventionsAL-208 Placebo

DrugsAL-208 Placebo

Overview

Phase: Phase 2
Intervention: AL-208
Conditions: Mild Cognitive Impairment
Sponsor: Allon Therapeutics
Enrollment: 234
Locations: 28
Primary Endpoint: 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.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

June 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Allon Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females (of non-childbearing potential), 50 to 79 years of age.
•Undergoing CABG surgery with the use of extracorporeal circulation.
•Willing and able to complete cognitive testing.
•Score \< 16 on the Center for Epidemiological Studies in Depression scale (CES-D).
•Score \> or = 28 on the Mini-Mental State Examination (MMSE).
•Willing and able to provide informed consent to participate in this study
•Fluency in written and spoken English.

Exclusion Criteria

•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.
•History of stroke or other significant neurological disorder
•Transient ischemic attack (TIA) with ongoing cognitive sequelae
•Chronic atrial fibrillation or uncontrolled atrial fibrillation prior to surgery
•Myocardial infarction (MI) within the last 8 weeks and/or previous history of more than 3 MIs
•History of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes \> 2.5 x upper limit or normal (ULN) at screening).
•History of renal dysfunction with ongoing sequelae (including but not limited to creatinine value \> 2.5 mg/dL at screening).
•Known active alcohol or drug abuse.
•Concurrent use of prescription medications known to enhance memory
•General anesthesia (defined as anesthesia requiring intubation or ventilatory support) within 3 months prior to randomization.

Arms & Interventions

AL-208

1 dose of 300 mg

Intervention: AL-208

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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(14 days)
Concentration of AL-208 in plasma in subjects undergoing CABG surgery(14 days)