WASHINGTON, DC — Adding a potent antagonist of the 5-HT6 serotonin receptor (RVT-101, Axovant Sciences Inc) to standard dementia care with donepezil (Aricept, Eisai Inc and Pfizer Inc) improves cognitive outcomes in patients with mild to moderate Alzheimer’s disease (AD), results of a new phase 2b double-blind, controlled study reveal.
On the basis of these results, company officials are keen to move forward with the investigational agent. “With these data in hand, we are one study away from being able to file this with the FDA [Food and Drug Administration],” Ilise Lombardo, MD, vice president, clinical research, Axovant Sciences Inc, toldMedscape Medical News.
The company presented data on the patients who were “completers,” or had data available for each time point in the study, at the Alzheimer’s Association International Conference (AAIC) 2015. Positive intention-to-treat (ITT) analyses from the same trial have already been published.
The new “exceptionally robust” findings are at least as strong as — if not a bit more so — those in the ITT population, said Dr Lombardo.
Alzheimer’s Association International Conference (AAIC) 2015. Oral presentation DT-01-04. Presented July 22, 2015.