The Phase II clinical trial was conducted at 28 medical centres in the US and Canada. The study was a randomized, placebo-controlled, double-blind, parallel-group evaluation of the safety, tolerability and effect of a single 300mg intravenous infusion of AL-208 administered 30 minutes prior to coronary artery bypass graft (CABG) surgery. Approximately half of the 210 patients randomized were treated with AL-208 and half were given a placebo.
The primary objective of the randomized study is to demonstrate an impact on cognitive performance in patients treated with AL-208 compared with patients given placebo when measured 2-3 weeks post surgery. Cognitive performance was assessed by a regimen of neuropsychological tests evaluating memory and executive function. The study will also expand the safety database on this drug. The company expects to release top-line results from this trial in the third quarter of 2008.
Gordon McCauley, president and CEO of Allon, said: “The trial will determine whether a single dose of AL-208 administered to patients prior to CABG surgery has an impact on their cognitive performance two to three weeks after their surgery.”