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Real-world evidence for amyloid-targeted therapies: Lecanemab and donanemab
Ryan Hakim, Kristofer Harris, Livia Merrill, Amanda Falk-Vargas, Eileen Whalen, Tianxu Xia, Olga Ochoa, David Hunter et al.. Alzheimer's & dementia (Amsterdam, Netherlands), 2026-08-26
Topic: Drug trials: efficacy and safety
Plain-language summary
Amyloid-related imaging abnormalities (ARIA) occurred in 11.2% (10/89) with lecanemab and 13.3% (11/83) with donanemab-less than in pivotal trials. Modified donanemab titration reduced ARIA versus the original protocol (8.1% vs 28.6%; p = 0.03) and TRAILBLAZER-ALZ 6 (23.6%). No anaphylaxis occurred. Surveillance magnetic resonance imaging captured 95.2% of ARIA events. Within-center comparison showed comparable safety between lecanemab and modified-titration donanemab (all p's > 0.40). IRRs occurred in 12.0% (donanemab) and 9.0% (lecanemab). In a real-world cohort representing patients excluded from trials, ARIA and IRR rates matched or improved upon pivotal trials, supporting safe ATT use under FDA-approved MRI intervals.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Hakim, R., Harris, K., Merrill, L., Falk-Vargas, A., Whalen, E., Xia, T., et al. (2026). Real-world evidence for amyloid-targeted therapies: Lecanemab and donanemab. Alzheimer's & dementia (Amsterdam, Netherlands). https://doi.org/10.1002/dad2.70404
Vancouver
Hakim R, Harris K, Merrill L, Falk-Vargas A, Whalen E, Xia T, et al. Real-world evidence for amyloid-targeted therapies: Lecanemab and donanemab. Alzheimer's & dementia (Amsterdam, Netherlands). 2026. doi:10.1002/dad2.70404. PMID: 42661728.
BibTeX
@article{hakim2026-42661728,
author = {Hakim, Ryan and Harris, Kristofer and Merrill, Livia and Falk-Vargas, Amanda and Whalen, Eileen and Xia, Tianxu and Ochoa, Olga and Hunter, David and others},
title = {{Real-world evidence for amyloid-targeted therapies: Lecanemab and donanemab}},
journal = {Alzheimer's \& dementia (Amsterdam, Netherlands)},
year = {2026},
doi = {10.1002/dad2.70404},
pmid = {42661728},
url = {https://doi.org/10.1002/dad2.70404}
}
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Key findings
- Amyloid-related imaging abnormalities (ARIA) occurred in 11.2% (10/89) with lecanemab and 13.3% (11/83) with donanemab-less than in pivotal trials.
- Modified donanemab titration reduced ARIA versus the original protocol (8.1% vs 28.6%; p = 0.03) and TRAILBLAZER-ALZ 6 (23.6%).
- Surveillance magnetic resonance imaging captured 95.2% of ARIA events.
- Within-center comparison showed comparable safety between lecanemab and modified-titration donanemab (all p's > 0.40).
- IRRs occurred in 12.0% (donanemab) and 9.0% (lecanemab).
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Study details
- Participants89
- Effect size72.7%; 11.2%; 13.3%
- Evidence strengthModerate
How this study scored 63/100
Published in a leading specialty journal. Scored zero for study design and randomized / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record, multicenter collaboration and free to read, so those were left out: it earned 35 of the 56 points we could judge it on, which is 63 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia (Amsterdam, Netherlands)) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 3 / 5 | Rated “moderate” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 1 / 4 | 89 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomized / blinded | 0 / 2 | No randomization or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multicenter collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 42661728) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 35 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 35 of the 56 points we could judge it on is 63 out of 100. |
| Total | 63 / 100 | — |
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