Voyager sees positive data from Ph II AD trial

US biopharmaceutical company Voyager Pharmaceutical says that trial data demonstrates that leuprolide acetate helps women with mild-to-moderate Alzheimer's disease to maintain functional capabilities for an extended period, in comparison with standard care. The findings, which were presented at a symposium held during the International Conference on Alzheimer's Disease and Related Disorders, in Madrid, Spain, are derived from a Phase II trial of the drug combined with acetylcholinesterase inhibitors in women with AD.

The program, which was a double-blind, placebo-controlled assessment that ran for 48-weeks, examined the drug in combination with AChEI versus AChEI and placebo. Treatment efficacy was measured according to the following three criteria: cognitive ability, assessed via the ADAS-Cog system; clinical impression, a physician or caregiver-based rating known as ADCS-CGIC; and the ability to perform daily activities, quantified using the ADCD-ADL scale.

The results showed that subjects who received the combined treatment declined 0.18 points on the ADAS-Cog scale compared with a mean 3.30 point drop in those receiving placebo. In the ADCS-CGIS analysis, 58% of those in the drug-treated cohort scored "no change" or better, versus 48% of those in the placebo group. Additionally, the subgroup ADCS-ADL assessment revealed that patients on the combined regimen declined an average 0.54 points, as opposed to those in the placebo arm where there was an average 6.85 drop.