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The approval by the Food and Drug Administration in 2023 of lecanemab — a groundbreaking Alzheimer’s treatment demonstrated in clinical studies to gradually slow disease advancement — was greeted with excitement by many professionals in the domain as it signified the first drug of its kind capable of affecting the condition. However, side effects — including brain swelling and bleeding — surfaced during trials, leaving some patients and healthcare providers uncertain about the therapy.
Once medications are introduced to the general population, their effects can vary significantly across diverse demographics. Investigators at Washington University School of Medicine in St. Louis aimed to examine the adverse reactions linked to lecanemab administration among their clinic patients, discovering that noteworthy adverse reactions were infrequent and manageable.
In alignment with outcomes from meticulously regulated clinical trials, the researchers found that merely 1% of patients encountered severe side effects necessitating hospitalization. Patients at the initial phase of Alzheimer’s with exceedingly mild symptoms exhibited the least likelihood of complications, which aids in guiding discussions between patients and clinicians regarding the treatment’s risks.
The retrospective investigation, published on May 12 in JAMA Neurology, concentrated on 234 individuals with very mild or mild Alzheimer’s disease who received lecanemab infusions at the Memory Diagnostic Center at WashU Medicine, a specialized clinic focusing on dementia treatment.
“This new category of medications for early symptomatic Alzheimer’s is the only sanctioned treatment that impacts disease progression,” stated Barbara Joy Snider, MD, PhD, a neurology professor and co-senior author of the study. “However, apprehension regarding the drug’s potential side effects can result in delays in treatment. Our research indicates that WashU Medicine’s outpatient clinic possesses the framework and proficiency to safely administer and support patients on lecanemab, including the few who may experience severe side effects, paving the way for more clinics to safely provide the drug to patients.”
Lecanemab is an antibody-based therapy that eliminates amyloid plaque proteins, extending independent living by 10 months, according to a recent study spearheaded by WashU Medicine researchers. As amyloid buildup is the initial step in the disease, medical professionals recommend this medication for individuals in the early stage of Alzheimer’s, with very mild to mild symptoms. The researchers noted that just 1.8% of patients with very mild Alzheimer’s symptoms developed any adverse effects from the treatment, in contrast to 27% of those with mild Alzheimer’s.
“Patients with the mildest symptoms of Alzheimer’s are likely to gain the most benefit while facing the least risk of adverse events from treatment,” remarked Snider, who oversaw clinical trials for lecanemab at WashU Medicine. “Delay and avoidance can compel patients to postpone treatment, thereby increasing the likelihood of side effects. We aspire to reshape the discussions between healthcare providers and patients regarding the medication’s risks.”
Concerns about lecanemab originate from a side effect referred to as amyloid-related imaging abnormalities, also known as ARIA. These abnormalities, which typically affect only a minor area of the brain, are evident on imaging scans and signify swelling or bleeding. In the clinical trials for lecanemab, 12.6% of participants encountered ARIA, with most cases being asymptomatic and resolving independently. A small fraction — approximately 2.8% of treated participants — experienced symptoms such as headaches, confusion, nausea, and dizziness. Rare fatalities have been associated with lecanemab in an estimated 0.2% of patients treated.
The Memory Diagnostic Center initiated treatment with lecanemab in 2023 following the drug’s complete FDA approval. Patients receive the medication through infusions every two weeks in specialized infusion centers. As part of each patient’s treatment plan, WashU Medicine physicians routinely conduct advanced imaging to monitor the brain, which can detect bleeding and swelling with excellent precision. Lecanemab is halted in patients exhibiting symptoms from ARIA or significant ARIA without symptoms, and the rare patients encountering severe ARIA are treated with steroids in a hospital setting.
Upon reviewing their patients’ outcomes, the authors observed that the extent of side effects was consistent with those seen in the trials — the majority of the clinic’s ARIA cases were asymptomatic and only identified through sensitive brain scans used to track cerebral changes. Among the 11 patients who exhibited symptoms due to ARIA, the effects predominantly subsided within a few months, and no patients succumbed.
“The majority of patients on lecanemab manage the drug remarkably well,” stated Suzanne Schindler, MD, PhD, an associate neurology professor and co-senior author of the study. “This report could assist patients and providers in better comprehending the treatment risks, which are diminished in patients with very mild Alzheimer’s symptoms.”
Paczynski M, Hofmann A, Posey Z, Gregersen M, Rudman M, Ellington D, Aldinger M, Musiek ES, Holtzman DM, Bateman RJ, Long JM, Ghoshal N, Carr DB, Dow A, Namazie-Kummer S, Jana N, Xiong C, Morris JC, Benzinger TLS, Schindler SE, Snider BJ. Lecanemab treatment in a specialty memory clinic: feasibility and safety. JAMA Neurology. May 12, 2025.
This research received backing from a donation and startup funding from the Barbara Morriss trust.
Paczynski M has acted as a site sub-investigator for clinical trials backed by Eisai and participated in one scientific advisory board for Eisai. The lab of Musiek ES has previously acquired research funding from Eisai for animal studies associated with sleep. Holtzman DM co-founded, holds equity, receives royalty income based on technology (stable isotope labeling kinetics and blood plasma assay) and is on the scientific advisory board of C2N Diagnostics, which provides the PrecivityAD2 blood test. He also serves on the scientific advisory boards of Denali, Genentech, Cajal Neuroscience, and Switch therapeutics, and consults for Asteroid and Pfizer. Bateman RJ has received research funding from Avid Radiopharmaceuticals, Janssen, Roche/Genentech, Eli Lilly, Eisai, Biogen, AbbVie, Bristol Myers Squibb, and Novartis. He co-founded C2N Diagnostics, which offers the PrecivityAD2 blood test. Washington University and Bateman RJ possess equity ownership interest in C2N Diagnostics and obtain income based on technology (stable isotope labeling kinetics, blood plasma assay, and methods of diagnosing AD with phosphorylation changes) licensed from Washington University to C2N Diagnostics. Bateman RJ receives income from C2N Diagnostics for serving on the scientific advisory board. He serves as an unpaid member on scientific advisory boards for Roche and Biogen. Long JM has acted as site sub-investigator for clinical trials supported by Eisai and Eli Lilly. He has participated in an advisory board concerning blood-based biomarker testing for Lucent Diagnostics. He has received compensation for involvement on a Data Safety Monitoring Board for Noah Pharmaceuticals. Ghoshal N has either participated or is presently involved in clinical trials for anti-dementia drugs backed by Bristol Myers Squibb, Eli Lilly/Avid Radiopharmaceuticals, Janssen Immunotherapy, Novartis, Pfizer, Wyeth, Roche, Eisai, SNIFF (The Study of Nasal Insulin to Combat Forgetfulness), and the A4 (The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease) trial. She serves as a consultant.
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for BCBSA. Carr DB has acted as co-principal investigator for clinical studies funded by Biogen, Eisai, Eli Lilly, and Hoffman La Roche. He has provided consultancy for the Traffic Injury Research Foundation, Medscape, and UpToDate. Dow A is an advisor on the Lecanemab Site of Care Strategic Council for Eisai, with his consulting fees directed to the BJC Employee Assistance Fund. Benzinger TLS has acquired grants or contracts from Siemens allocated to her institution and received consulting payments from Biogen, Eli Lilly, Eisai, Bristol Myers Squibb, J&J, and Merck. She has been involved in a Data Safety Monitoring Board or Advisory Board for Siemens. She has obtained technology transfer and precursors for radiopharmaceuticals from Avid Radiopharmaceuticals/Eli Lilly, LMI, and Lantheus, in addition to a scanner loan from Hyperfine to her institution. Schindler SE has participated in scientific advisory boards concerning biomarker testing and clinical care pathways for Eisai and Novo Nordisk, as well as received speaking fees for discussions on biomarker testing from Eisai, Eli Lilly, and Novo Nordisk. Snider BJ has served as a site principal investigator for clinical trials financed by Biogen, Eisai, Eli Lilly, and Hoffman La Roche. She has been part of scientific advisory boards focused on the usage of anti-amyloid treatments for Biogen, Eisai, and Roche.
About Washington University School of Medicine
WashU Medicine is a prominent entity in academic medicine, encompassing biomedical research, patient care, and educational initiatives with 2,900 faculty members. Its National Institutes of Health (NIH) research funding portfolio ranks as the second largest among U.S. medical institutions and has expanded by 56% over the last seven years. Along with institutional investment, WashU Medicine allocates well over $1 billion annually to fundamental and clinical research advancement and training. Its faculty practice consistently ranks among the top five in the nation, consisting of over 1,900 faculty physicians operating at 130 locations, who also constitute the medical staff of Barnes-Jewish and St. Louis Children’s hospitals under BJC HealthCare. WashU Medicine boasts a rich history in MD/PhD training, having recently committed $100 million toward scholarships and curriculum updates for its medical scholars, along with top-tier training programs across every medical subspecialty, including physical therapy, occupational therapy, and audiology and communication sciences.
Originally published on the WashU Medicine website
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