Biogen launches real-world study for controversial Aduhelm

July 30, 2021

Biogen has revealed the details of the first real-world observational phase 4 study in Alzheimer’s disease in a late-breaking presentation made at the Alzheimer’s Association International Conference in Denver.

ICARE AD-US is a prospective study of Aduhelm designed to collect real-world, long-term effectiveness and safety data on the recently-approved treatment.

Biogen has been under scrutiny since Aduhelm was given conditional approval by the FDA in June. Before the FDA decision, critics pointed out that the lack of a peer-reviewed paper about the drug looked suspicious. Recently, two sources told the media site Axios that Biogen submitted a paper to JAMA, but opted to rescind its submission after the journal requested certain edits.

The ICARE AD-US study intends to enroll patients with Alzheimer’s disease over four years from approximately 200 sites in the U.S. Patients will be monitored for a period of up to five years. Specifically, the objective will be to characterize and evaluate real-world, long-term changes in cognition, function, and neuropsychiatric status in Aduhelm-treated patients. Secondary objectives are related to gaining a better understanding of Aduhelm safety in real-world clinical practice.

Importantly, the study design will help address the common underrepresentation of Black/African American and Latinx patients in Alzheimer’s disease studies, aiming to enroll at least 16% of the trial’s expected 6,000 participants from these communities.

Read the Biogen press release