Nature Medicine: Alzheimer’s guidance

April 4, 2013

The US Food and Drug Administration (FDA) plans to lower the evidentiary bar needed for an Alzheimer's treatment to gain approval. According to draft guidelines released in February and described by agency officials on 13 March in the New England Journal of Medicine (http://doi.org/kv7, 2013), drugs targeted at patients early in the course of their disease could be initially approved off the back of improvements in cognition (such as memory) alone, with functional gains on daily chores demonstrated later through post-marketing studies. “This FDA guidance is providing us with an accelerated way to bring drugs to market,” says Howard Fillit, executive director and chief scientific officer of the Alzheimer's Drug Discovery Foundation in New York. “But I'm concerned because some of those drugs that have an effect on cognition might not prove clinically meaningful,” he adds.