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Lecanemab in Early Alzheimer's Disease
van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. New England Journal of Medicine, 2023-01-05
Topic: Amyloid, tau and blood-test diagnosis
This is the primary Phase 3 Clarity AD trial report for lecanemab. In 1,795 people with early Alzheimer's disease randomized to lecanemab or placebo every two weeks for 18 months, lecanemab slowed decline on the main dementia-severity scale (CDR-SB) by a small but statistically significant amount (change of 1.21 vs 1.66 points, a difference of 0.45 points on an 18-point scale). Infusion reactions occurred in about a quarter of patients, and brain swelling (ARIA-E) occurred in about 1 in 8.
Key findings
- n=1,795 (898 lecanemab, 897 placebo); 18-month double-blind Phase 3 trial
- Adjusted mean CDR-SB change: 1.21 (lecanemab) vs 1.66 (placebo); difference −0.45 (less decline with lecanemab)
- Infusion-related reactions in 26.4% of participants; ARIA-E (brain swelling/effusion) in 12.6%
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Study details
- Study designphase-3-trial
- Participants1,795
- Effect sizeAdjusted mean CDR-SB change 1.21 (lecanemab) vs. 1.66 (placebo); difference -0.45
- Evidence strengthModerate
Limitations
Modest absolute effect size (0.45 points on an 18-point scale) of debated long-term clinical meaningfulness; high rates of infusion reactions (26.4%) and ARIA-E (12.6%); 18-month duration does not establish long-term outcomes.
How this study scored 74/100
Published in a top-tier journal, and it is a large phase 3 trial. Scored zero for indexed in PubMed 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, 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 46 of the 62 points we could judge it on, which is 74 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 10 / 10 | Tier 1 — top-tier general journal (New England Journal of Medicine) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A large phase 3 trial |
| 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 | 3 / 5 | 2023 — within 6 year(s) of the newest study here |
| Sample size | 3 / 4 | 1,795 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) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| 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 | 0 / 6 | No other study in this library cites it |
| 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 | 0 / 2 | No PubMed ID and no DOI — scores zero (not stated in the record — scored 0) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 46 / 62 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 46 of the 62 points we could judge it on is 74 out of 100. |
| Total | 74 / 100 | — |
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Read the original
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. This record has no DOI, so the citation leaves it out. Volume, issue and page numbers are not held in the record. The record names 19 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
APA 7th
van Dyck, C. H., Swanson, C. J., Aisen, P., Bateman, R. J., Chen, C., Gee, M., et al. (2023). Lecanemab in Early Alzheimer's Disease. New England Journal of Medicine.
Vancouver
van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, et al. Lecanemab in Early Alzheimer's Disease. New England Journal of Medicine. 2023. PMID: 36449413.
BibTeX
@article{vandyck2023-22dd8fce,
author = {van Dyck, C. H. and Swanson, C. J. and Aisen, P. and Bateman, R. J. and Chen, C. and Gee, M. and Kanekiyo, M. and Li, D. and Reyderman, L. and Cohen, S. and Froelich, L. and Katayama, S. and Sabbagh, M. and Vellas, B. and Watson, D. and Dhadda, S. and Irizarry, M. and Kramer, L. D. and Iwatsubo, T.},
title = {{Lecanemab in Early Alzheimer's Disease}},
journal = {New England Journal of Medicine},
year = {2023},
pmid = {36449413}
}
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