Evaluating Safety and Early Outcomes of Lecanemab Treatment for Alzheimer Disease: Philip Kuball, MD

WATCH TIME: 2 minutes

“Before we make any big claims or conclusions, we need to have more time for treatment. We also need to recruit more patients too. There are a lot of unanswered questions, and in order to feel confident in any takeaways, we need more data.”

To assess patient outcomes with lecanemab (Leqembi; Eisai), an FDA-approved treatment for Alzheimer disease (AD), researchers recently established a 5-member neurology review committee modeled after a tumor board approach. This group, based at the Pearl Barlow Center for Memory Evaluation & Treatment, met regularly to unanimously approve patients for treatment based on strict eligibility criteria. These included confirmed AD diagnosis via CSF or Amyvid PET, Mini-Mental State Examination (MMSE) more than 20, Clinical Dementia Rating (CDR) of 0.5–1, APOE genotyping, fewer than 4 microhemorrhages on MRI, and no concurrent anticoagulant or immunomodulatory use or active cancer. MRI monitoring was conducted before the 5th, 7th, and 14th infusions to track potential complications such as ARIA.

Over the first 9 months of treatment, cognitive decline appeared modest and aligned with outcomes reported in the phase 3 Clarity AD trial (NCT03887455). At baseline, patients had a mean CDR of 0.73 and MMSE of 24.13. Over time, CDR scores remained relatively stable at 0.70 (± .27) at 3 months (P = .03), 0.72 (± .25) at 6 months (P = .05), and increased slightly to 0.85 (± .24) at 9 months (P = .08). MMSE scores were 24.4 (± 3.23) at 3 months (P = .077), 23.4 (± 3.91) at 6 months (P = .067), and declined more noticeably to 21.65 (± 3.69) at 9 months (P = .003). Amyloid-related imaging abnormalities (ARIA)-edema and ARIA-hemorrhage events were most common early in treatment, affecting up to 11 patients at 6 months, particularly those with the APOE4 allele. Researchers noted that 8 patients discontinued therapy during the study, but no deaths were linked to lecanemab.^1,2

These results were recently presented at the 2025 American Academy of Neurology (AAN) Annual Meeting, held April 5-9, in San Diego, California, by lead author Philip Kuball, MD, a resident in the Department of Neurology at NYU Langone Health. In a conversation with with NeurologyLive^®, Kuball outlined the early experience with lecanemab treatment in the patient cohort and discussed the value of implementing a review committee to monitor safety and track outcomes. Although the early findings showed some patients experienced slowed decline or transient cognitive improvement, Kuball stressed that more time and a larger patient population may be needed before drawing definitive conclusions.

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REFERENCES
1. Kuball P, Watkins K, Stobin I, et al. Early Clinical Outcomes following Lecanemab Therapy for Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease. Presented at: 2025 AAN Annual Meeting; April 5-9; San Diego, CA. Innovations in Dementia Treatment.
2. NYU Langone Neurologists Present Latest Clinical Findings & Research at AAN 2025. News Release. NYU Langone Health. Published April 4, 2025. Accessed April 17, 2025. https://nyulangone.org/news/nyu-langone-neurologists-present-latest-clinical-findings-research-aan-2025