The DOI matches its Crossref record.
The Importance of Early Recognition and Treatment Initiation for Managing Alzheimer’s disease: Subpopulation Analysis of the TRAILBLAZER-ALZ 2 Randomized Trial (S23.005)
Abstract
Objective: To assess efficacy and safety of donanemab in participants at earlier clinical (mild cognitive impairment [MCI]) and pathological (low-medium tau) stages of Alzheimer’s disease (AD). Background: Compared with other contemporary early symptomatic AD studies, TRAILBLAZER-ALZ 2 (TB2) for donanemab included a broad and more clinically advanced population (Mini-Mental State Examination [MMSE] score 20–28 [inclusive]) with higher pathological disease burden (participants with low-medium and high tau and higher baseline amyloid, as measured by positron emission tomography [PET]). Design/Methods: A pre-specified subpopulation analysis of participants (placebo N=105; donanemab N=123) with MCI (baseline MMSE score ≥ 27) and low-medium tau PET burden from TB2 for efficacy and safety. Results: The MCI and low-medium tau subpopulation had relatively lower baseline plasma P-tau217 and similar amyloid burden (106 Centiloids) compared with the overall TB2 population (MCI or mild dementia due to AD with confirmed amyloid and tau pathology [low-medium or high tau PET level]). In the MCI and low-medium tau subpopulation, participants experienced 60% slowing of disease progression in the integrated Alzheimer’s Disease Rating Scale (22% slowing in the overall population); 46% slowing in Clinical Dementia Rating Scale–Sum of boxes (29% slowing in the overall population) at Week 76. Comparable to the overall population, amyloid-related imaging abnormalities of edema or effusion occurred…
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“reports of findings from the subgroup analysis of phase 3 trial TRAILBLAZER-ALZ2 suggest that donanemab is more effective in participants with less cognitive impairment and lower tau burden [16, 18].”
In the citing paper
“A growing number of studies – with lecanemab and donanemab – are finding that the earlier stage of disease and/or the AD pathology, the greater the effect size in clinical benefit [14–17].”
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Di Caro, V., Cho, E., Thiel, J., Lizama, B. N., Koel-Simmelink, M. J. A., Pandey, K., Duong, D., Seyfried, N. T., Grundman, M., Teunissen, C. E., et al. (2026) · Alzheimer's Research & Therapy · doi:10.1186/s13195-026-02025-4 · Cited by 1
Metadata
- Authors
- Vasudeva, R., Doty, E., Yang, F., Evans, C., Zimmer, J., Lu, M., Singh, J., & Sims, J.
- Affiliations
- Eli Lilly and Company
- Venue
- Neurology
- Published
- 2025-04-08
- Volume
- 104
- Issue
- 7_Supplement_1
- ISSN
- 0028-3878
- 1526-632X
- Cited by
- 1
- References
- 0
- Language
- en
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