The impact of real-world evidence in implementing and optimizing Alzheimer’s disease care
Harald Hampel, Gang Li, Michelle M. Mielke, James E. Galvin, Miia Kivipelto, Emiliano Santarnecchi, Claudio Babiloni, Viswanath Devanarayan, Rifky Tkatch, Yan Hu, Ricky Kurzman, Min Cho, Jo Vandercappellen, Yosuke Nakamura, J. Simon Bell, Soeren Mattke, Nicola Toschi
Abstract
Real-world evidence (RWE) can complement clinical trials by addressing gaps in how approved anti-amyloid therapies for early Alzheimer's disease (AD) are used in everyday practice. This article outlines strategies to generate RWE that bridge three key challenges in AD care: low detection rates of mild cognitive impairment (MCI), limited data on long-term safety and effectiveness, and a lack of personalized treatment strategies. With MCI detection rates among primary care providers as low as 6%-15%, we propose cost-effective triage tools using electronic health records to enhance early diagnosis and intervention. We also highlight the importance of understanding anti-amyloid therapy outcomes in diverse, real-world populations. Supported by FDA initiatives, pragmatic trials and observational studies using real-world data (RWD) can help develop predictive models that incorporate biomarkers and support precision medicine. These approaches aim to move AD care beyond one-size-fits-all treatment, guiding more tailored, effective strategies for patients.