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Many Alzheimer’s patients would not have been eligible for clinical trials of controversial new drug

In June 2021, the Food & Drug Administration (FDA) granted accelerated approval for aducanumab to treat patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease. The two phase-3 clinical trials of aducanumab on which the drug’s approval was based showed increased risk of certain adverse vascular events. Though the clinical trials excluded participants based on advanced age, certain chronic diseases and use of anti-clotting medications, FDA approval was granted without contraindications or precautions for use of the drug in these patient populations.

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