Conflicting results for aducanumab in two phase 3 trials for early Alzheimer's
In short: Researchers conducting two phase 3 clinical trials found that the monoclonal antibody aducanumab showed different results for patients with early Alzheimer's disease. While the EMERGE study found a statistically significant benefit in cognitive and functional outcomes for the high-dose group, the ENGAGE study failed to meet its primary and secondary endpoints.
The studies evaluated aducanumab, an antibody targeting amyloid beta, in patients with mild cognitive impairment or mild Alzheimer's dementia. While biomarker studies showed the drug successfully reduced markers of the disease, the clinical outcomes were inconsistent between the two trials.
The trials were randomized, double-blind, and placebo-controlled, but both were halted early based on futility analysis of the first half of enrolled patients.
Why it matters: The inconsistent clinical results of aducanumab highlight the complexity of treating early Alzheimer's disease.
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