Abstract Details

Title Baseline Characteristics and Preliminary Safety from a Multicenter, Safety Surveillance Study of Lecanemab Treatment for Alzheimer’s Disease in Real-world Clinical Practice Using Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) Registry

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P1 - Poster Session 1 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-014

Objective To report baseline characteristics and preliminary safety data from participants included in a multicenter, safety surveillance study of commercial lecanemab treatment for Alzheimer’s disease in real-world clinical practice using ALZ-NET registry.

Background Lecanemab, an antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ), is approved for the treatment of AD. Lecanemab is also approved as a maintenance therapy of either once-monthly IV infusion or a weekly self-administered subcutaneous injection after completing the initial 18-month intravenous (IV) treatment in the United States.

Design/Methods This is a post-marketing, multicenter, safety surveillance study of commercial lecanemab for the treatment of participants with AD in real-world clinical practice using ALZ-NET registry that will last 10 years. Physicians participating in the ALZ-NET registry prescribe lecanemab at their discretion and based on the approved United States Prescribing Information. The primary objective of the study is to evaluate the safety of lecanemab in the real-world clinical setting with a focus on ARIA events.

Results At the time of data cut off (23 May 2025), 742 participants were treated with commercial lecanemab, with a mean duration of lecanemab exposure of 8.4 months. The incidence of ARIA-E was 5% (1.1% symptomatic ARIA-E), with all cases observed within the first 6 months of treatment. ARIA-H occurred in 7% of participants (1.3% symptomatic ARIA-H). Severity of ARIA events were 97.3% and 96.2% mild-to-moderate in ARIA-E and ARIA-H respectively. ARIA-E and ARIA-H events both led to discontinuation of lecanemab in 1.6% of participants. Intracerebral hemorrhage (ICH) greater than 1 cm in diameter occurred in 2 participants (0.3%). One death possibly related to commercial lecanemab was reported (pulmonary embolism).

Conclusions Results from surveillance study in real-world settings are consistent with the known lecanemab profile. No new safety signals were observed.

Authors/Disclosures
Marwan Sabbagh, MD PRESENTER	Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alzheon. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche-Genentech. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Sabbagh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novo Nordisk. Dr. Sabbagh has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for EIP Pharma.
Laura L. Cornelissen, PhD	Dr. Cornelissen has nothing to disclose.
Sophia Michael, MD, PhD	Dr. Michael has nothing to disclose.
Ilona Surick, MD	Dr. Surick has received personal compensation for serving as an employee of Eisai Inc.
Shobha Dhadda	Shobha Dhadda has received personal compensation for serving as an employee of Eisai Inc.
Michio Kanekiyo, MS	Mr. Kanekiyo has received personal compensation for serving as an employee of Eisai Inc. Mr. Kanekiyo has stock in Eisai Co Ltd..
Steven M. Hersch, MD, PhD (Eisai Inc.)	Dr. Hersch has received personal compensation for serving as an employee of Eisai Inc.. Dr. Hersch has stock in Voyager Therapeutics. The institution of an immediate family member of Dr. Hersch has received research support from NIH. Dr. Hersch has received intellectual property interests from a discovery or technology relating to health care.
Michael C. Irizarry, MD (Eisai, Inc)	Dr. Irizarry has received personal compensation for serving as an employee of Eisai, Inc..

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