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. 2025 Jul 1;82(7):655-665.
doi: 10.1001/jamaneurol.2025.1232.

Lecanemab Treatment in a Specialty Memory Clinic

Madeline Paczynski  1   2 , Anna Hofmann  1   2 , Zachary Posey  1 , Maren Gregersen  1   2 , Michelle Rudman  1   2 , Dawn Ellington  1 , Melissa Aldinger  1   2 , Erik S Musiek  1   2 , David M Holtzman  1   2 , Randall J Bateman  1   2 , Justin M Long  1   2 , Nupur Ghoshal  1   2 , David B Carr  3 , Alan Dow  4 , Sheyda Namazie-Kummer  4 , Nayid Jana  5 , Chengjie Xiong  1   2   6 , John C Morris  1   2 , Tammie L S Benzinger  2   5 , Suzanne E Schindler  1   2 , B Joy Snider  1   2
Affiliations

Lecanemab Treatment in a Specialty Memory Clinic

Madeline Paczynski et al. JAMA Neurol. .

Erratum in

Abstract

Importance: Two monoclonal antibodies targeting amyloid plaques, lecanemab and donanemab, have received traditional US Food and Drug Administration (FDA) approval for the treatment of early symptomatic Alzheimer disease (AD). The most significant adverse events associated with these therapies are infusion-related reactions and amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and/or hemorrhage/hemosiderin deposition (ARIA-H). The feasibility and safety of providing these treatments in clinical practice is unclear.

Objective: To examine the feasibility and safety of treating patients in specialty memory clinics with lecanemab.

Design, setting, and participants: This retrospective analysis of consecutive patients in whom lecanemab was initiated between August 1, 2023, and October 1, 2024, at Washington University Memory Diagnostic Center, an outpatient specialty memory clinic. Lecanemab was initiated in 234 patients with early symptomatic AD. Eligibility was based on the FDA label and appropriate use recommendations with occasional exceptions.

Exposure: Patients were treated with lecanemab, 10 mg/kg, intravenously every 2 weeks.

Main outcomes and measures: Infusion-related reactions, ARIA, and withdrawal from treatment were assessed.

Results: The 234 patients treated with lecanemab had a mean age of 74.4 (SD, 6.7) years, 117 were female (50%), and 117 were male (50%). Infusion-related reactions occurred in 87 patients (37%) and were typically mild. Of the 194 patients at risk for ARIA during the study period, 44 had at least 1 microhemorrhage and/or superficial siderosis before initiation of lecanemab (23%). Over an average treatment period of 6.5 months, 42 total patients (22%) developed ARIA; 29 developed ARIA-E with or without ARIA-H (15%) and 13 developed isolated ARIA-H (6.7%). Eleven patients (5.7%) developed symptomatic ARIA, 2 of those patients (1.0%) with clinically severe symptoms. No patients developed a macrohemorrhage or died. Patients with mild dementia had a 27% rate of symptomatic ARIA; those with mild cognitive impairment or very mild dementia had a 1.8% rate. Overall, 23 of 234 patients (9.8%) withdrew from treatment for various reasons, 10 for ARIA (4.3%).

Conclusions and relevance: A single-specialty memory clinic initiated lecanemab treatment in 234 patients over 14 months. The frequency of significant adverse events, including ARIA, was manageable. These results may inform discussions about the risks of anti-amyloid treatments.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Paczynski reported personal fees from Eisai honorarium less than $500 received for participating in scientific board meeting and serving as subinvestigator on sponsored clinical trials from Eisai and Eli Lilly outside the submitted work. Dr Musiek reported grants and personal fees from Eisai outside the submitted work. Dr Holtzman reported personal fees from C2N Diagnostics, Genentech, Cajal Neurosciences, Pfizer, Switch Therapeutics, Denali, and Asteroid outside the submitted work. Dr Bateman reported being cofounder of C2N Diagnostics during the conduct of the study. Dr Bateman also reported a patent for blood test ptau217 and amyloid-beta issued to C2N Diagnostics Washington University licensed, grants from the National Institute on Aging (R01AG068319, UFAG032438, RF1AG061900, R56AG061900), the Alzheimer’s Association (DIAN-TU-OLE-21-725093, DIAN-TU-Tau-21-822987), the National Institute of Neurological Disorders and Stroke/National Institute on Aging (R01NS095773) Centene Corporation, Rainwater Foundation, Association for Frontotemporal Degeneration, Biogen, BrightFocus Foundation, Cure Alzheimer’s Fund, Coins for Alzheimer’s Research, Eisai, The Foundation for Barnes-Jewish, TargetALS, Good Ventures Foundation, and DIAN-TU Pharma, consortium membership from Biogen, Neurofilament, AbbVie, Bristol Meyer, Novartis, Eli Lilly and Company/Avid Radiopharmaceuticals, Hoffman-La Roche/Genentech, Biogen, Eisai, and Janssen and previous consortium membership from Abbvie, Amgen, AstraZeneca, Forum, Mithridion, Novartis, Pfizer, United Neuroscience, Sanofi, Eli Lilly and Company Tau SILK, and receipt of drugs and support from Hoffman-La Roche Receipt, CogState, and Signant. Dr Long reported personal fees from Lucent Diagnostics, Noah Pharmaceuticals, and Peerview Institute outside the submitted work. Dr Ghoshal reported consultant fees from The Blue Cross Blue Shield Association, grants from Tau Consortium, the Association for Frontotemporal Dementia, and the National Institutes of Aging outside the submitted work; and Dr Ghoshal has participated or is currently participating in clinical trials of anti-dementia drugs sponsored by Bristol Myers Squibb, Eli Lilly/Avid Radiopharmaceuticals, Janssen Immunotherapy, Novartis, Pfizer, Wyeth, Roche, Eisai, SNIFF (The Study of Nasal Insulin to Fight Forget-fulness), and the A4 (The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease) trial. Dr Carr reported pharmaceutical drug studies with Biogen, Eli Lilly, Hoffman La Roche, and Eisai and consultant fees from the Traffic Injury Research Foundation, Medscape, and UpToDate during the conduct of the study. Dr Dow reported consulting fees paid to Barnes-Jewish Hospital from Eisai. Dr Morris reported grants from the National Institute of Health during the conduct of the study. Dr Benzinger reported grants from Siemens, loan of equipment from Hyperfine, precursors and technology transfer from Lantheus Radiopharmaceutical and Eli Lilly/Avid Radiopharmaceuticals, personal fees from Biogen, Eli Lilly, Eisai, Bristol Myers Squibb, Johnson & Johnson, and Merck, and payment for generation of medical education activities from Medscape, PeerView, and Neurology Today outside the submitted work. Dr Schindler reported personal fees from Eisai, Eli Lilly, and Novo Nordisk outside the submitted work; and Dr Schindler’s employer, Washington University, has a stake in C2N Diagnostics. Dr Snider reported advisory board fees and grants from Eisai and Eli Lilly outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Lecanemab Infusions, Monitoring Magnetic Resonance Imaging (MRI) Scans, and Amyloid-Related Imaging Abnormalities (ARIA) Over Time
Each circle indicates 1 infusion with the color denoting the number of the infusion. A indicates ARIA; N, non–ARIA event, eg, non–ARIA related issues, such as a fall.
Figure 2.
Figure 2.. Percent of Patients With Amyloid-Related Imaging Abnormalities (ARIA) Over the First 14 Months of Treatment
The analyses include only the 194 individuals at risk for ARIA who received at least 4 infusions of lecanemab and underwent at least 1 monitoring magnetic resonance imaging. The proportion of patients without isolated ARIA-H, ARIA with edema/effusion (ARIA-E) with or without ARIA with hemorrhage hemosiderin deposition (ARIA-H), or any ARIA is shown as a function of the time since first infusion. The average length of treatment was 6.5 months (see eTable 2 in Supplement 1 for length of follow-up).
Figure 3.
Figure 3.. Radiographic and Clinical Severity of Amyloid-Related Imaging Abnormalities (ARIA) Cases
For asymptomatic (A) and symptomatic (B) ARIA cases, the number of cases is shown according to the maximal radiographic severity of ARIA with hemorrhage hemosiderin deposition (ARIA-H) and ARIA with edema/effusion (ARIA-E). The size of the circle corresponds to the number of patients.
See this image and copyright information in PMC

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