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The Anti-Amyloid Monoclonal Antibody Lecanemab: 16 Cautionary Notes
Kasper P Kepp, Stefano L Sensi, Kasper B Johnsen, Jorge R Barrio, Poul F Høilund-Carlsen, Rachael L Neve, Abass Alavi, Karl Herrup et al.. Journal of Alzheimer's disease : JAD, 2023
Topic: Drug trials: efficacy and safety
After the CLARITY-AD clinical trial results of lecanemab were interpreted as positive, and supporting the amyloid hypothesis, the drug received accelerated Food and Drug Administration approval. However, we argue that benefits of lecanemab treatment are uncertain and may yield net harm for some patients, and that the data do not support the amyloid hypothesis. We note potential biases from inclusion, unblinding, dropouts, and other issues. Given substantial adverse effects and subgroup heterogeneity, we conclude that lecanemab's efficacy is not clinically meaningful, consistent with numerous analyses suggesting that amyloid-β and its derivatives are not the main causative agents of Alzheimer's disease dementia.
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APA 7th
Kepp, K. P., Sensi, S. L., Johnsen, K. B., Barrio, J. R., Høilund-Carlsen, P. F., Neve, R. L., et al. (2023). The Anti-Amyloid Monoclonal Antibody Lecanemab: 16 Cautionary Notes. Journal of Alzheimer's disease : JAD. https://doi.org/10.3233/jad-230099
Vancouver
Kepp KP, Sensi SL, Johnsen KB, Barrio JR, Høilund-Carlsen PF, Neve RL, et al. The Anti-Amyloid Monoclonal Antibody Lecanemab: 16 Cautionary Notes. Journal of Alzheimer's disease : JAD. 2023. doi:10.3233/jad-230099. PMID: 37334596.
BibTeX
@article{kepp2023-37334596,
author = {Kepp, Kasper P and Sensi, Stefano L and Johnsen, Kasper B and Barrio, Jorge R and Høilund-Carlsen, Poul F and Neve, Rachael L and Alavi, Abass and Herrup, Karl and others},
title = {{The Anti-Amyloid Monoclonal Antibody Lecanemab: 16 Cautionary Notes}},
journal = {Journal of Alzheimer's disease : JAD},
year = {2023},
doi = {10.3233/jad-230099},
pmid = {37334596},
url = {https://doi.org/10.3233/jad-230099}
}
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Key findings
- After the CLARITY-AD clinical trial results of lecanemab were interpreted as positive, and supporting the amyloid hypothesis, the drug received accelerated Food and Drug Administration approval.
- Given substantial adverse effects and subgroup heterogeneity, we conclude that lecanemab's efficacy is not clinically meaningful, consistent with numerous analyses suggesting that amyloid-β and its derivatives are not the main causative agents of Alzheimer's disease dementia.
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Study details
- Evidence strengthLow
How this study scored 41/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomised / 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, multi-centre collaboration and free to read, so those were left out: it earned 23 of the 56 points we could judge it on, which is 41 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Journal of Alzheimer's disease : JAD) |
| 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 | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2023 — within 6 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 | No randomisation 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 |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 37334596) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 23 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 23 of the 56 points we could judge it on is 41 out of 100. |
| Total | 41 / 100 | — |
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