Lundbeck's Investigational Compound Meets Primary Endpoint

The study was conducted in 278 patients suffering from moderate Alzheimer’s disease, and Lu AE58054 was administered as add-on to donepezil, a commonly used acetylcholinesterase inhibitor for a period of 24 weeks.

H. Lundbeck A/S (Lundbeck) has announced that its investigational compound Lu AE58054 has met primary endpoint in a fixed dose, randomized, placebo-controlled clinical study in 278 patients suffering from Alzheimer's disease.

Lu AE58054 is a novel, selective 5HT6 receptor antagonist with a different mechanism of action than currently available Alzheimer's medications.

Augmentation therapy with Lu AE58054 (plus10mg/day donepezil) at the selected dose resulted in statistically significant improvement in cognition, as measured by the ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive sub-scale) over a 24 week treatment period versus placebo (plus10mg/day donepezil). Secondary endpoints, including measures of global status and activities of daily living also showed posit