ICARE AD-US: Design of a Prospective, Single-Arm, Multicenter, Noninterventional, Real-World Study of Aducanumab in the United States
James E. Galvin1, Jeffrey Cummings2, Mihaela Levitchi Benea3, Carl de Moor3, Alireza Atri4,5, Verna Porter6, Ivana Rubino3
1Comprehensive Center for Brain Health, Department of Neurology, University of Miami, 2Chambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada, 3Biogen, 4Banner Sun Health Research Institute, 5Brigham and Women’s Hospital and Harvard Medical School, 6Pacific Brain Health Center
Objective:

The ICARE AD-US study is designed to collect longitudinal clinical, imaging, and pharmacoeconomic data to evaluate the safety and effectiveness of aducanumab in real-world clinical practice.

Background:

Aducanumab was approved for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) or mild dementia due to AD by the US Food and Drug Administration (FDA) under the accelerated approval pathway. Aducanumab is the first FDA-approved AD treatment that selectively targets aggregated forms of amyloid beta (Aβ). The efficacy and safety of aducanumab have been evaluated in 2 Phase 3 studies, and it is now critical to evaluate its long-term impact in the real world.

Design/Methods:
ICARE AD-US is a prospective, single-arm, multicenter, noninterventional study of aducanumab as prescribed in a postmarketing, real-world US setting. This Phase 4 observational study is designed to evaluate the safety and effectiveness of aducanumab in clinical practice per its FDA-approved labeling. The primary objectives are to evaluate real-world, long-term changes in cognition, function, and neuropsychiatric status in aducanumab-treated patients and characterize the longitudinal impact of aducanumab on quality of life, disease burden, and health care resource utilization. ICARE AD-US will also assess long-term safety as measured by serious adverse events and the incidence of amyloid-related imaging abnormalities–edema (ARIA-E). Biobanking of collected blood will provide opportunities for future biomarker studies.
Results:
ICARE AD-US aims to enroll ~6000 patients with AD over 4 years, including ~500 African American and ~500 Hispanic/Latinx patients, at ~200 US sites. Patients will be monitored for up to 5 years.
Conclusions:
The study will collect a harmonized core dataset to assess the long-term effectiveness and safety of aducanumab treatment in real-world clinical practice and the effectiveness and safety of aducanumab in patients from underrepresented racial and ethnic minority groups to inform real-world clinical practice.