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.
The impact of real-world evidence in implementing and optimizing Alzheimer’s disease care / Hampel, Harald; Li, Gang; Mielke, Michelle M.; Galvin, James E.; Kivipelto, Miia; Santarnecchi, Emiliano; Babiloni, Claudio; Devanarayan, Viswanath; Tkatch, Rifky; Hu, Yan; Kurzman, Ricky; Cho, Min; Vandercappellen, Jo; Nakamura, Yosuke; Bell, Joanne; Mattke, Soeren; Toschi, Nicola. - In: MED. - ISSN 2666-6340. - 6:5(2025), pp. 1-12. [10.1016/j.medj.2025.100695]
The impact of real-world evidence in implementing and optimizing Alzheimer’s disease care
Babiloni, ClaudioMembro del Collaboration Group
;
2025
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.| File | Dimensione | Formato | |
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