journal articles
THE EFFECT OF MODIFIED DONANEMAB TITRATION ON AMYLOID-RELATED IMAGING ABNORMALITIES WITH EDEMA/EFFUSIONS AND AMYLOID REDUCTION: 18-MONTH RESULTS FROM TRAILBLAZER-ALZ 6
Hong Wang, Emel Serap Monkul Nery, Paul Ardayfio, Rashna Khanna, Diana Otero Svaldi, Sergey Shcherbinin, Wen Xu, Scott W. Andersen, Paula M. Hauck, Dawn A. Brooks, Emily C. Collins, Stephen Salloway, Mark A. Mintun, John R. Sims
The TRAILBLAZER-ALZ 6 study (NCT05738486) evaluated the effect of different donanemab dosing regimens on amyloid-related imaging abnormalities with edema/sulcal effusions (ARIA-E). The modified titration arm met the primary outcome and significantly reduced ARIA-E frequency compared with the standard dosing while maintaining a similar pharmacodynamic effect on amyloid reduction at 24 weeks. Primary outcome and 52-week data were previously published. Completed study results at 76 weeks are reported here. ARIA-E frequencies were 15.6 % and 24.2 % in the modified titration and standard arms, respectively. ARIA-E radiographic severity was significantly lower (p = 0.015) with modified titration than with standard dosing. Additionally, symptomatic ARIA-E frequency was lower with modified titration versus standard dosing (2.8 % vs 4.8 %). The frequency of serious adverse events was comparable between the modified titration and standard dosing arms. A more gradual titration of donanemab dosing significantly reduced ARIA-E risk versus standard dosing.
CITATION:
Hong Wang ; Emel Serap Monkul Nery ; Paul Ardayfio ; Rashna Khanna ; Diana Otero Svaldi ; Sergey Shcherbinin ; Wen Xu ; Scott W. Andersen ; Paula M. Hauck ; Dawn A. Brooks ; Emily C. Collins ; Stephen Salloway ; Mark A. Mintun ; John R. Sims (2025): The effect of modified donanemab titration on amyloid-related imaging abnormalities with edema/effusions and amyloid reduction: 18-month results from TRAILBLAZER-ALZ 6. The Journal of Prevention of Alzheimer’s Disease (JPAD). https://doi.org/10.1016/j.tjpad.2025.100266