A Duke/UNC Alzheimer’s Disease Research Center (ADRC) investigator is leading new research that provides important insights into the real-world use of lecanemab, one of the first disease-modifying therapies approved for people with early Alzheimer’s disease. The study, led by Andy J. Liu, a Duke/UNC ADRC Core Leader, analyzed treatment outcomes among patients receiving lecanemab at Duke University and offers valuable information for patients, families, clinicians, and researchers as the use of anti-amyloid therapies continues to expand.

Lecanemab was approved by the U.S. Food and Drug Administration in 2023 for people with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s dementia who have evidence of amyloid plaques in the brain. While clinical trials showed that the therapy can slow cognitive decline, researchers have continued to study how the treatment performs in routine clinical care.

In the new study, Duke researchers reviewed outcomes from 230 patients treated with lecanemab between 2023 and 2025. Participants had either MCI or mild Alzheimer’s disease and confirmed amyloid pathology. The research team evaluated treatment outcomes, cognitive changes, and the occurrence of amyloid-related imaging abnormalities (ARIA), a known side effect that can involve brain swelling or small areas of bleeding that are monitored through MRI scans.

The investigators found that approximately one in four patients experienced ARIA during treatment, most often within the first several months. They also found that individuals carrying the APOE ε4 genetic variant, a known genetic risk factor for Alzheimer’s disease, were more likely to develop ARIA than non-carriers. These findings highlight the importance of careful patient selection, genetic counseling, and ongoing MRI monitoring throughout treatment.

Importantly, the researchers found that commonly used clinical measures were not particularly effective at predicting which patients would develop ARIA. The authors noted that additional research is needed to improve individualized risk assessment and help patients and clinicians make informed decisions about treatment.

For participants in the Duke/UNC ADRC, the study demonstrates how research continues long after a therapy receives regulatory approval. Clinical trials establish whether a treatment is effective, but real-world studies help researchers understand how therapies perform in broader patient populations and how side effects can be identified and managed in everyday practice.

The project also reflects the collaborative nature of Alzheimer’s research at Duke and the Duke/UNC ADRC. Alongside Liu, the study included contributions from Duke Alzheimer’s researchers Dr. Heather Whitson and Dr. P. Murali Doraiswamy, whose work focuses on cognitive aging, Alzheimer’s disease, and improving care for people living with dementia.

As disease-modifying therapies become increasingly available, research led by Duke/UNC ADRC investigators will play an important role in helping patients and families understand both the potential benefits and risks of treatment. Studies like this one provide practical information that can improve patient care today while guiding the next generation of Alzheimer’s disease research