Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction
In TRAILBLAZER-ALZ 6, the amyloid-related imaging abnormalities-edema/effusions (ARIA-E) frequency was 13.7% in the modified titration arm compared to 23.7% in the standard arm at week 24. The modified titration arm met the primary endpoint of ARIA-E relative risk reduction at 24 weeks versus the standard arm. The modified titration versus standard arm at week 24 had comparable non-ARIA-E related safety profile, amyloid reduction, plasma phosphorylated tau217 reduction, cumulative exposure, and pharmacokinetics. Data at week 52 were consistent with week 24 results.
Authors
- Rashna Khanna
- Stephen Salloway (ORCID: https://orcid.org/0000-0002-2631-0942)
- Staci E. Engle (ORCID: https://orcid.org/0000-0002-8116-5063)
- Nick C. Fox (ORCID: https://orcid.org/0000-0002-6660-657X)
- Dawn A. Brooks
- Ivelina Gueorguieva (ORCID: https://orcid.org/0000-0001-5864-8924)
- Sergey Shcherbinin
- Diana Otero Svaldi (ORCID: https://orcid.org/0000-0001-6265-1931)
- Emel Serap Monkul Nery
- Steven Mark Greenberg (ORCID: https://orcid.org/0000-0003-1792-8887)
- Mark A. Mintun
- Paula M. Hauck (ORCID: https://orcid.org/0000-0002-2889-235X)
- Hong Wang (ORCID: https://orcid.org/0000-0002-5348-362X)
- Scott W. Andersen (ORCID: https://orcid.org/0000-0002-2679-3921)
- John R. Sims
- Paul Ardayfio
- Emily C. Collins
Institutions
- Harvard University (US)
- Eli Lilly (United States) (US)
- Providence College (US)
- Brown University (US)
- Butler Hospital (US)
- Massachusetts General Hospital (US)
- UK Dementia Research Institute (GB)
- National Hospital for Neurology and Neurosurgery (GB)
- University College London (GB)
Publication Details
- Journal
- Alzheimer s & Dementia
- Published
- 2025-04-01
- DOI
- https://doi.org/10.1002/alz.70062
- Citations
- 35
- Primary Topic
- Alzheimer's disease research and treatments
- Type
- article
- Field-Weighted Citation Impact
- 40.75
Funders
- Eli Lilly and Company