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Review
. 2025 May 9;6(5):100695.
doi: 10.1016/j.medj.2025.100695.

The impact of real-world evidence in implementing and optimizing Alzheimer's disease care

Harald Hampel  1 , Gang Li  2 , Michelle M Mielke  3 , James E Galvin  4 , Miia Kivipelto  5 , Emiliano Santarnecchi  6 , Claudio Babiloni  7 , Viswanath Devanarayan  8 , Rifky Tkatch  8 , Yan Hu  8 , Ricky Kurzman  8 , Min Cho  8 , Jo Vandercappellen  8 , Yosuke Nakamura  8 , Joanne Bell  8 , Soeren Mattke  9 , Nicola Toschi  10
Affiliations
Free article
Review

The impact of real-world evidence in implementing and optimizing Alzheimer's disease care

Harald Hampel et al. Med. .
Free article

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.

Keywords: Alzheimer’s disease; Translation to patients; patient care; precision medicine; primary care provider; real-world evidence.

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Conflict of interest statement

Declaration of interests H.H., G.L., J.V., J.B., R.K., M.C., V.D., R.T., and Y.H. are employees of Eisai, Inc. H.H. also serves as a reviewing editor for the journal Alzheimer’s & Dementia. He is an inventor of 11 patents and has received no royalties: (1) In Vitro Multiparameter Determination Method for the Diagnosis and Early Diagnosis of Neurodegenerative Disorders, patent no. 8916388; (2) In Vitro Procedure for Diagnosis and Early Diagnosis of Neurodegenerative Diseases, patent no. 8298784; (3) Neurodegenerative Markers for Psychiatric Conditions, publication no. 20120196300; (4) In Vitro Multiparameter Determination Method for the Diagnosis and Early Diagnosis of Neurodegenerative Disorders, publication no. 20100062463; (5) In Vitro Method for the Diagnosis and Early Diagnosis of Neurodegenerative Disorders, publication no. 20100035286; (6) In Vitro Procedure for Diagnosis and Early Diagnosis of Neurodegenerative Diseases, publication no. 20090263822; (7) In Vitro Method for the Diagnosis of Neurodegenerative Diseases, patent no. 7547553; (8) CSF Diagnostic in Vitro Method for Diagnosis of Dementias and Neuroinflammatory Diseases, publication no. 20080206797; (9) In Vitro Method for the Diagnosis of Neurodegenerative Diseases, publication no. 20080199966; (10) Neurodegenerative Markers for Psychiatric Conditions, publication no. 20080131921; and (11) Method for diagnosis of dementias and neuroinflammatory diseases based on an increased level of procalcitonin in cerebrospinal fluid, publication no. US Patent 10921330. M.M.M. has served as a consultant to Eisai, Inc., Brain Protection Company, and BioGen and receives research support from the National Institutes of Health and the Department of Defense. She is a senior associate editor for Alzheimer’s & Dementia: the Journal of the Alzheimer’s Association. J.E.G. provides consultation for Biogen, Eisai, Eli Lilly, Genentech, and Roche and receives funding from the National Institutes of Health. M.K. receives research support from the Academy of Finland, the Swedish Research Council, the Alzheimer’s Association, the AXA Research Fund, and the EU 7th framework large collaborative project grant (HATICE). She has served on scientific advisory boards for Pfizer, Inc., Elan Corporation, Alzheon, and Nutricia and has received speaker honoraria from Janssen, Novartis, Pfizer, Inc., and Merz. N.T. has provided consultation to Eisai, Inc. S.M. serves on the board of directors of Senscio Systems and the scientific advisory board of AiCure Technologies, ALZpath, and Boston Millennia Partners and has received consulting fees from Biogen, C2N, Eisai, Novartis, and Roche/Genentech.

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