A groundbreaking study suggests that analyzing blood biomarkers after treatment with lecanemab, an Alzheimer’s disease medication, could predict the therapy’s effectiveness. Researchers at Korea University Guro Hospital have published findings indicating that changes in specific blood markers can serve as an early indicator of how well the drug will work for individual patients.
Predicting Alzheimer’s Treatment Response with Blood Tests
The research, published in the esteemed international journal ‘Alzheimer’s & Dementia,’ focused on the blood biomarker p-tau217. Lecanemab, a disease-modifying therapy (DMT) approved in South Korea in December 2024, targets amyloid-beta, a key culprit in Alzheimer’s progression, aiming to slow the disease’s advancement. While the drug has seen rapid adoption, its high cost and variable patient responses have underscored the need for objective methods to monitor treatment efficacy early on.
The study utilized data from the K-LEARN (Korean Lecanemab Real-world Evidence and Response Network) cohort, a real-world clinical database established at Korea University Guro Hospital. This prospective study involved 153 patients with early-stage Alzheimer’s disease who were receiving lecanemab treatment. Researchers conducted repeated blood tests before and after treatment to analyze long-term changes in p-tau217 levels, a marker known to be sensitive to changes in brain amyloid pathology.
Key Findings on p-tau217 Levels
The results revealed a significant decrease in p-tau217 levels starting from three months after treatment initiation. The most substantial reduction was observed between three and six months, after which the levels appeared to stabilize. This pattern suggests that the decline in p-tau217 can reflect the reduction in brain amyloid pathology and associated Alzheimer’s-related changes brought about by lecanemab therapy.
Furthermore, the research team identified two distinct response groups based on p-tau217 changes during the initial six months of treatment:
- Group A: Patients in this group showed a significant decrease in p-tau217 after six months, followed by a relatively slower rate of cognitive decline up to 12 months.
- Group B: This group experienced a less pronounced reduction in p-tau217 over the six-month period. Consequently, their cognitive function worsened more rapidly compared to Group A.
Implications for Personalized Treatment
The study also noted that patients with hypertension showed a comparatively smaller decrease in p-tau217. This finding implies that vascular health, including conditions like hypertension, might influence the biological response to anti-amyloid therapies. It highlights the importance of actively managing vascular risk factors, such as high blood pressure, during treatment.
Professor Kang Sung-hoon, the lead researcher, stated, “These results demonstrate that p-tau217 can be utilized as a blood biomarker to predict lecanemab’s future treatment response in the early stages of therapy.” He emphasized the study’s significance as the first to report that early changes in p-tau217 levels within the first six months of treatment can predict subsequent cognitive outcomes in a real-world clinical setting. Unlike previous studies that relied on pre-treatment biomarker levels, this research analyzed the dynamic changes in biomarkers over time to predict clinical outcomes, providing valuable information for treatment management.
Previously, blood biomarkers for Alzheimer’s disease were primarily considered for diagnostic purposes. However, this research by Professor Kang’s team confirms that blood biomarkers can be used to objectively monitor treatment effectiveness and predict individual patient responses to lecanemab therapy in clinical practice.
Future Directions and K-LEARN Cohort
The findings are expected to be crucial in developing personalized treatment strategies for Alzheimer’s disease, utilizing blood biomarkers to tailor therapy for each patient. Professor Kang added, “Korea University Guro Hospital is not only one of the leading institutions actively administering lecanemab treatment in Korea but also a center that has proactively accumulated clinical treatment outcomes and real-world data for anti-amyloid therapies.” He expressed the hospital’s commitment to continuing research using the K-LEARN cohort and clinical experience to lead in personalized Alzheimer’s treatment strategies based on blood biomarkers.
The K-LEARN cohort, which forms the basis of this study, is designed to longitudinally collect standardized data on real-world clinical outcomes, blood biomarkers, MRI scans, amyloid PET imaging, and cognitive function changes in patients receiving lecanemab treatment. The research team plans to continue accumulating real-world clinical data through K-LEARN, aiming to integrate blood biomarker information with imaging and clinical data to predict individual patient responses and guide personalized treatment plans.
This advancement holds significant promise for improving the management of Alzheimer’s disease, offering a more precise and individualized approach to treatment efficacy monitoring and prediction.
