Biogen and Eisai have unveiled the design of a real-world observational Phase IV study, named ICARE AD-US, of Aduhelm (aducanumab-avwa) in Alzheimer’s disease.

The first-of-its-kind prospective study will gather real-world data on the long-term effectiveness and safety of 100mg/mL injectable solution of Aduhelm.

Aducanumab-avwa is a monoclonal antibody that targets amyloid beta. The amyloid beta plaques build-up in the brain is considered a major pathophysiological indicator of Alzheimer’s.

The drug received accelerated approval for the treatment of Alzheimer’s patients suffering from mild cognitive impairment or mild dementia. It is not indicated for the disease’s earlier or later stages.

Supported by the decrease in amyloid-beta plaques in Aduhelm-treated trial patients, the approval of the drug in this indication is dependent on confirmation of its clinical benefit in further trials.

ICARE AD-US is expected to collect data on the drug’s long-term effectiveness and safety when prescribed in routine clinical practice in the US.

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The study’s primary objective is to depict and assess any Aduhelm-related long-term changes in cognition, function and neuropsychiatric status in real-world patients.

In addition, ICARE AD-US aims to obtain better insights into the drug’s safety in a real-world setting.

With a target enrolment of 6,000 subjects, the study will focus on involving diverse populations, including a minimum of 16% of African American and Latinx patients.

The enrolment will take place over four years at nearly 200 US sites and patients will be observed for up to five years.

Biogen Alzheimer’s Disease medical global head Ivana Rubino said: “Biogen is committed to both generating new data about Aduhelm and supporting steps to bring adequate representation to this trial and other clinical trials from traditionally underrepresented groups.

“We believe this can help us better understand the safety and effectiveness of treatment in patients with Alzheimer’s disease across ethnicities, something that has challenged researchers in this field for decades.”

Apart from ICARE AD-US, the clinical programmes designed to collect new Aduhelm data are the ongoing Phase IIIb EMBARK re-dosing study and the confirmatory Phase IV trial that is being currently designed.