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Biogen and Eisai announce the design of the observational study evaluating the effectiveness and safety of aducanumab

Thursday 29 July 2021

On 29 July, Biogen and Eisai presented the design of the new observational Phase IV study in Alzheimer’s disease (AD), named ICARE AD-US, at the Alzheimer’s Association International Conference (AAIC).

Following the recent announcement by the US Food and Drug Administration (FDA) to approve aducanumab for the treatment of AD, Biogen has been required to conduct a post-approval clinical trial to confirm the benefit of the drug. ICARE AD-US is a study that will provide information on the long-term effectiveness and safety of aducanumab, which is delivered via monthly intravenous infusions and involves regular monitoring via brain scans. The primary objective of the study is to characterise and evaluate real-world, long-term changes in cognition, function and neuropsychiatric status in people receiving aducanumab. Secondary objectives are related to gaining a better understanding of the drug’s safety in real-world clinical practice.

The ICARE AD-US trial is expected to enrol 6,000 participants with AD over four years from approximately 200 sites in the US, with at least 16% of Latinx and Black/African American participants, as part of Biogen’s commitment to increase participation from traditionally underrepresented communities. All the participants will be monitored for a period of up to five years. This study is part of one of three programs to generate post-approval data on aducanumab, including the ongoing re-dosing Phase IIIb EMBARK study and the planned confirmatory Phase IV post-marketing requirement study.