Biogen and Eisai Co., Ltd. announced that Biogen led a late-breaking presentation on the design of the first real-world observational Phase 4 study in Alzheimer's disease called ICARE AD-US, at the Alzheimer's Association International Conference (AAIC), being held both virtually and in Denver, Colo. from July 26 – 30, 2021. ICARE AD-US, a prospective study of ADUHELM™ (aducanumab-avwa) 100 mg/mL solution for injection, is designed to collect real-world, long-term effectiveness and safety data on ADUHELM.

The virtual oral session (#57522) was titled, ICARE AD-US: design of a prospective, single-arm, multicenter, noninterventional real-world study of aducanumab in United States. ADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

ICARE AD-US is a real-world study that will provide information on the long-term effectiveness and safety of ADUHELM as prescribed in routine clinical practice in the U.S. based on the label approved by the U.S. Food and Drug Administration (FDA). The primary objective of the study is 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.

The study design includes an important goal to 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. Alzheimer's disease clinical trials commonly have 1% to 2% enrollment from these groups, even though Black/African Americans and Latinx people are respectively two and one-and-a-half times more likely than older White Americans to have Alzheimer's disease. The 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.