Representativeness of participants eligible to be enrolled in clinical trials of aducanumab for Alzheimer disease compared with Medicare beneficiaries with Alzheimer disease and mild cognitive impairment

JAMA

9 September 2021 - In June 2021, the US FDA granted accelerated approval for aducanumab to treat patients with mild cognitive impairment or mild dementia due to Alzheimer disease, despite limited evidence of clinical benefit. 

The two Phase 3 clinical trials of aducanumab, EMERGE and ENGAGE, were stopped prematurely based on pre-specified futility thresholds Both trials also showed an increased risk of adverse events with aducanumab, including microhemorrhages and vasogenic brain oedema, headache, and possibly falls. 

Though both trials excluded patients based on age, certain chronic diseases, and use of anti-platelet agents and anticoagulants, FDA approval was granted without contraindications or precautions for these unstudied patient populations. 

We evaluated whether patients enrolled in the trials of aducanumab were representative of patients with dementia enrolled in Medicare by estimating the proportions of Medicare beneficiaries with Alzheimer's disease or mild cognitive impairment who would have been excluded from the trials.

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Michael Wonder

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Michael Wonder

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Medicine , US , Medicare , Clinical trial