Accelerating Alzheimer’s Diagnosis Through Innovative Biomarker Research

Imagine a future where physicians could diagnose Alzheimer’s disease (AD) or mild cognitive impairment (MCI) with a simple blood test. People could be diagnosed in earlier stages of disease – potentially even before symptoms appear –through a less invasive method, which would pose fewer costs and reduce the strain on the healthcare system.

With nearly seven million people in the United States living with Alzheimer’s dementia and the annual number of new cases of Alzheimer’s and other dementias projected to double by 2050, the need for new AD solutions, including diagnostics, is crucial. The early stages of disease, like MCI due to AD, offer a critical window for intervention before symptoms become severe, yet only a fraction of patients are currently identified in this pivotal stage.

Historically, diagnostic frameworks have been based on clinical symptoms unsuitable for multifactorial and chronic diseases like AD, in which early stages can start long before symptoms appear. Traditional diagnostic techniques, such as lumbar punctures, are often met with resistance from patients due to the perceived invasiveness of the procedure. While many patients have benefitted from the increasing availability of amyloid imaging using positron emission tomography (PET), this method, along with the use of plasma in cerebrospinal fluid (CSF), places a significant burden on patients in terms of access, costs, and physical well-being. In order to overcome the challenges with diagnosis, Eisai is pioneering research by exploring biomarkers that can detect AD early and monitor disease progression.

Utilizing Biomarkers to Improve Alzheimer’s Diagnosis

Biomarkers are essentially biologic indicators, which can indicate the presence or absence of a disease, as well as the risk of developing a disease. In the case of AD, biomarkers are often detectable long before patients show symptoms, creating opportunities to prevent or delay symptom onset.

Over the last three decades, significant progress has been made in validating fluid and neuroimaging biomarkers that chart AD pathophysiological alterations. Biomarkers such as tau have been instrumental in this progress. Blood-based biomarkers are also particularly promising for large-scale, minimally invasive screening, enabling early diagnosis and treatment.

Leveraging the research being done in the lab, Eisai recently partnered with Sysmex Corporation to advance the development of blood-based assays to detect potential biomarkers. This collaboration aims to create accessible, easy-to-use tests that can support large-scale screening for AD brain changes and potentially improve outcomes for patients and their families. Eisai has also partnered with C2N Diagnostics to expand the availability, accessibility, affordability, and utilization of blood-based tests for the diagnosis of AD in the U.S.?

Eisai’s relentless pursuit of innovation in biomarker research in AD is paving the way for a new era in diagnosis and treatment. By focusing on early detection, there is an opportunity to not only advance the scientific understanding of AD but also offer hope to millions of patients and their families worldwide.

To learn more about important advances in biomarker research to promote early detection and intervention, including Eisai’s efforts to develop easy-to-use tests and more, read the full blog here.

References

1.???? Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimers Dement 2024;20(5).

2.???? Jack, C. R., Jr. et al. Introduction to the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement 7, 257-262, doi:10.1016/j.jalz.2011.03.004 (2011).

3.???? Hampel H, Shaw LM, Aisen P, et al. State-of-the-art of lumbar puncture and its place in the journey of patients with Alzheimer's disease. Alzheimers Dement. 2022;18(1):159-177. doi:10.1002/alz.12372.

4.???? Jones, T., & Townsend, D. (2017). History and future technical innovation in positron emission tomography.?Journal of medical imaging (Bellingham, Wash.),?4(1), 011013. https://doi.org/10.1117/1.JMI.4.1.011013

5.???? Hampel, H., O'Bryant, S. E., Molinuevo, J. L., Zetterberg, H., Masters, C. L., Lista, S., Kiddle, S. J., Batrla, R., & Blennow, K. (2018). Blood-based biomarkers for Alzheimer disease: mapping the road to the clinic. Nature reviews. Neurology, 14(11), 639–652. https://doi.org/10.1038/s41582-018-0079-7

6.???? Jack, C. R., Jr. et al. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement 14, 535-562, doi:10.1016/j.jalz.2018.02.018 (2018).

7.???? Mantellatto Grigoli, M., Pelegrini, L. N. C., Whelan, R., & Cominetti, M. R. (2024). Present and Future of Blood-Based Biomarkers of Alzheimer's Disease: Beyond the Classics. Brain research, 1830, 148812. https://doi.org/10.1016/j.brainres.2024.148812

US4632 ? Eisai Inc. July 2024