Formularies and pharmacopoeias
Authors: J. Aronson
Journal: BMJ (2011)

<h3>Objective:</h3> 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. <h3>Background:</h3> 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. <h3>Design/Methods:</h3> 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. <h3>Results:</h3> 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. <h3>Conclusions:</h3> 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. <b>Disclosure:</b> Dr. Galvin has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Biogen. Dr. Galvin has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alpha Cognition. The institution of Dr. Galvin has received research support from National Institutes of Health. Dr. Galvin has received intellectual property interests from a discovery or technology relating to health care. Dr. Galvin has received intellectual property interests from a discovery or technology relating to health care. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ACADIA. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alkahest. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche/Genentech. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Green Valley. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novo Nordisk. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Otsuaka. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for United Neuroscience. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Cummings has received research support from NIH. Dr. Cummings has received intellectual property interests from a discovery or technology relating to health care. Mihaela Levitchi has received personal compensation for serving as an employee of Biogen. Mihaela Levitchi has received stock or an ownership interest from Biogen. Carl DeMoor has received personal compensation for serving as an employee of Biogen. Carl DeMoor has received stock or an ownership interest from Biogen. An immediate family member of Carl DeMoor has received personal compensation in the range of $100,000-$499,999 for serving as a Program Director with NIH. Dr. Porter has nothing to disclose. Ivana Rubino has received personal compensation for serving as an employee of Biogen. Ivana Rubino has received stock or an ownership interest from Biogen.