The study was conducted in 278 patients in Canada, Europe, and Australia with either Lu AE58054 (plus 10mg/day donepezil) or placebo (plus 10mg/day donepezil).
Lundbeck Canada scientific affairs senior director Jean Proulx said, "We see Lu AE58054 as having a strong potential in Alzheimer’s disease, a disease with a huge unmet medical need."
Patients receiving investigational compound achieved statistically significant improvement in cognition, as measured by the Alzheimer’s Disease Assessment Scale-cognitive sub-scale (ADAS-cog) over a 24-week treatment period versus donepezil monotherapy (10mg/day).
Measures of global status and activities of daily living, which were the secondary endpoints of the trial, also showed positive trends with the addition of Lu AE58054, compared with patients who received donepezil alone.
Treatment with augmentation therapy Lu AE58054 was well tolerated in the study, according to the company.
Lundbeck intends to initiate a major pivotal clinical program of Lu AE58054, potentially including development and commercial partnerships.