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.