miércoles, 15 de julio de 2020

Biogen's 'positive' Alzheimer's trial has a problem with small numbers - STAT

Biogen's 'positive' Alzheimer's trial has a problem with small numbers - STAT

The Readout

Damian Garde & Meghana Keshavan

Despite years of toil and rebuke, the amyloid hypothesis endures

Biogen and Eisai are embarking on yet another Phase 3 trial of yet another drug meant to treat Alzheimer’s disease by targeting a brain plaque called beta-amyloid, all despite a growing scientific consensus that the field needs some new ideas.

The drug in question, BAN2401, previously missed its primary goal in a Phase 2 trial, which was memorably presented at a confusing conference back in 2018. At the time, the companies claimed BAN2401 showed a benefit in a subset of the population and moved forward with a larger study enrolling people with early-stage Alzheimer’s.

Now, in collaboration with the NIH and academic groups, they’re planning to enroll 1,400 people who have no cognitive symptoms but test positive for amyloid in their brains. Patients will get either BAN2401 or placebo over more than four years with the goal of demonstrating the drug’s ability to prevent dementia.

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