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Two phase 3 trials of the investigational Alzheimer drug aducanumab were discontinued after a futility analysis found that they “were unlikely to meet their primary endpoint upon completion,” the manufacturers announced late last week.
The trials aimed to show that monthly aducanumab was better than placebo in slowing cognitive and functional impairment both in patients with mild cognitive impairment due to Alzheimer's and in patients with mild Alzheimer's dementia (NEJM JW Psychiatry Nov 2016 and Nature 2016; 537:50). The FDA had granted the companies fast-track designation for the drug's development.
A trial participant — and former New York Times reporter — shared his thoughts in a New York Times article.