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Re-evaluation of the efficacy and safety of anti-Aβ monoclonal antibodies (lecanemab/donanemab) in the treatment of early Alzheimer's disease
Wang H, Pan J, Zhang M, Tan Z.. Frontiers in pharmacology, 2025-04-16
Topic: Drug trials: efficacy and safety
Objective To systematically evaluate the efficacy and safety of anti-Aβ monoclonal antibodies (Lecanemab/Donanemab) in the treatment of early Alzheimer's disease (AD) and to provide evidence for rational clinical use. Methods We searched databases including PubMed, Embase, Cochrane, Web of Science, CNKI, and the Chinese Biomedical Literature Database for relevant literature on the use of anti-Aβ monoclonal antibodies in treating early AD. Two reviewers independently screened the literature, extracted data, and conducted meta-analysis using RevMan 5.4. Results A total of five clinical studies were included. Meta-analysis results showed that in terms of clinical outcomes, Lecanemab/Donanemab outperformed the control group in ADCOMS, CDR-SB, ADAS-Cog 14, and amyloid burden on PET. Regarding safety, the relative risk of amyloid-related imaging abnormalities (ARIA) in patients treated with Lecanemab/Donanemab was 4.35 times higher than the control group, with significantly higher risks of ARIA-E and ARIA-H. Among other adverse events, the risk of superficial siderosis of the central nervous system was notably higher and statistically significant. Conclusion Lecanemab/Donanemab can improve memory, cognitive function, and daily living abilities in patients with early AD, significantly reduce the composite score of Alzheimer's disease, and inhibit the accumulation of amyloid peptides, thereby alleviating symptoms and improving the condition.
Key findings
- Results A total of five clinical studies were included.
- Meta-analysis results showed that in terms of clinical outcomes, Lecanemab/Donanemab outperformed the control group in ADCOMS, CDR-SB, ADAS-Cog 14, and amyloid burden on PET.
- Regarding safety, the relative risk of amyloid-related imaging abnormalities (ARIA) in patients treated with Lecanemab/Donanemab was 4.35 times higher than the control group, with significantly higher risks of ARIA-E and ARIA-H.
- Among other adverse events, the risk of superficial siderosis of the central nervous system was notably higher and statistically significant.
- Conclusion Lecanemab/Donanemab can improve memory, cognitive function, and daily living abilities in patients with early AD, significantly reduce the composite score of Alzheimer's disease, and inhibit the accumulation of amyloid peptides, thereby alleviating symptoms and improving the condition.
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Study details
- Study designmeta-analysis
- Evidence strengthHigh
How this study scored 72/100
Published in a peer-reviewed journal, and it is a meta-analysis pooling many studies. Scored zero for sample size, effect reported and studied in people 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 and multi-centre collaboration, so those were left out: it earned 42 of the 58 points we could judge it on, which is 72 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Frontiers in pharmacology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 12 / 12 | A meta-analysis pooling many studies |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | A review of other studies — randomisation is not credited here |
| 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 |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40308765) |
| Free to read | 2 / 2 | Free to read |
| Points | 42 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 42 of the 58 points we could judge it on is 72 out of 100. |
| Total | 72 / 100 | — |
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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APA 7th
Wang, H., Pan, J., Zhang, M., & Tan, Z. (2025). Re-evaluation of the efficacy and safety of anti-Aβ monoclonal antibodies (lecanemab/donanemab) in the treatment of early Alzheimer's disease. Frontiers in pharmacology. https://doi.org/10.3389/fphar.2025.1599048
Vancouver
Wang H, Pan J, Zhang M, Tan Z. Re-evaluation of the efficacy and safety of anti-Aβ monoclonal antibodies (lecanemab/donanemab) in the treatment of early Alzheimer's disease. Frontiers in pharmacology. 2025. doi:10.3389/fphar.2025.1599048. PMID: 40308765.
BibTeX
@article{wang2025-40308765,
author = {Wang, H. and Pan, J. and Zhang, M. and Tan, Z.},
title = {{Re-evaluation of the efficacy and safety of anti-Aβ monoclonal antibodies (lecanemab/donanemab) in the treatment of early Alzheimer's disease}},
journal = {Frontiers in pharmacology},
year = {2025},
doi = {10.3389/fphar.2025.1599048},
pmid = {40308765},
url = {https://doi.org/10.3389/fphar.2025.1599048}
}
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