ALZ NET and Eisai Inc. to Collect Real World Data to Support Postmarketing Requirements for LEQEMBI® (lecanemab irmb)

CHICAGO, October 3, 2024 - Nearly seven million Americans are living with Alzheimer's disease or a related dementia, which for decades was considered a hopeless diagnosis. However, with treatments approved by the U.S. Food and Drug Administration (FDA) that can change disease progression, coupled with more than 140 therapies aimed against Alzheimer's in clinical trials or under regulatory review, we are in a new era of treatment.

"In this new era of treatment, there is an urgent need to better understand how new and future Alzheimer's therapies work in real-world settings," said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer and medical affairs lead. "By gathering and analyzing real-world data from people treated with FDA-approved Alzheimer's treatments, we can better understand their long-term health and safety outcomes in everyday settings, beyond controlled clinical trials."

The Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) is a first-of-its-kind Alzheimer's network dedicated to tracking real-world diagnostic and treatment outcomes. ALZ-NET is designed to work collaboratively with affiliated studies conducted by academia, industry, federal agencies, ALZ-NET project teams or others.

As with all therapies in this class, there is an FDA postmarketing requirement (PMR) for a registry-based study to evaluate clinical safety outcomes. Eisai Inc.'s PMR study of LEQEMBI® (lecanemab-irmb) is expected to begin in early 2025 and will last ten years. Eisai Inc. will conduct a registry-based, prospective, observational study to evaluate clinical safety outcomes among early Alzheimer's patients. ALZ-NET is collaborating with Eisai Inc. on an ALZ-NET-affiliated study that will collect real-world data to support the FDA postmarketing requirements.

"With ALZ-NET, we are unleashing a powerful tool in the fight against Alzheimer's disease: real-world data. ALZ-NET stands squarely at the intersection of treatment and care," said Carrillo. "This is a textbook example of a study that utilizes the infrastructure of the national ALZ-NET provider-enrolled patient registry to conduct regulatory-grade data collection and sharing to support regulatory reporting requirements."

To learn more about developing or conducting an ALZ-NET-affiliated study, visit alz-net.org.

About the Alzheimer's Association

The Alzheimer's Association is a worldwide voluntary health organization dedicated to Alzheimer's care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia - by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.

About ALZ-NET

ALZ-NET is a voluntary provider-enrolled patient network that collects real-world clinical and imaging data from people evaluated for or treated with new FDA-approved Alzheimer's therapies, including treatments designed to slow disease progression and those that treat cognitive, behavioral, or neuropsychiatric symptoms of Alzheimer's. It is sponsored by the Alzheimer's Association, managed and operated by the American College of Radiology, and approved by the Centers for Medicare and Medicaid Services as a Coverage with Evidence Development study. ALZ-NET can be used as a pathway to Medicare coverage for anti-amyloid Alzheimer's therapies that have received traditional FDA approval.

ALZ-NET is enrolling clinical sites across the country. Participation in ALZ-NET by health care providers and patients is encouraged by the FDA in the prescribing information of approved Alzheimer's medications and in the medical policies of private payers. To learn more visit alz-net.org.

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