Brain imaging abnormalities were frequently observed during aducanumab clinical trials
In short: Researchers analyzing two phase 3 clinical trials found that 41.3% of patients receiving aducanumab experienced amyloid-related imaging abnormalities (ARIA). In a group of 1,029 patients receiving the 10-mg/kg dose, the most frequent issue was ARIA-edema, which affected 35.2% of participants. While most cases resolved on MRI scans, about 26% of those with edema experienced symptoms like headaches or confusion.
The study integrated data from the EMERCO and ENGAGE trials, which compared aducanumab to a placebo in patients with early Alzheimer disease. While the findings characterize common side effects, the trials were terminated early due to a futility analysis, and the results are based on a specific subset of participants who underwent follow-up imaging.
The researchers analyzed data from 3,285 participants, focusing on those who received at least one dose of placebo or aducanumab during the placebo-controlled period.
Why it matters: The study provides a detailed characterization of the imaging abnormalities and symptoms associated with aducanumab treatment.
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Sources
- Source: Research: Salloway et al. (2021). Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurology. · cc-by-nc-nd
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