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Randomized Phase II Study of the Safety and Efficacy of Semorinemab in Participants With Mild-to-Moderate Alzheimer Disease: Lauriet
Monteiro C, Toth B, Brunstein F, Bobbala A, Datta S, Ceniceros R, Sanabria Bohorquez SM, Anania VG, Wildsmith KR, Schauer SP, Lee J, Dolton MJ, Ramakrishnan V, Abramzon D, Teng E, and the Lauriet investigators. Neurology, 2023-10-03
Topic: Amyloid, tau and blood-test diagnosis
This trial tested an antibody targeting tau tangles rather than amyloid plaques, in people with mild-to-moderate Alzheimer's. It slowed decline on one cognitive test by 42% compared with placebo, the first time an anti-tau antibody showed any cognitive benefit, but it did not help with daily-function scores, overall dementia staging (CDR-SB), or the MMSE, and it did not reduce tangle buildup seen on tau brain scans.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Monteiro, C., Toth, B., Brunstein, F., Bobbala, A., Datta, S., Ceniceros, R., et al. (2023). Randomized Phase II Study of the Safety and Efficacy of Semorinemab in Participants With Mild-to-Moderate Alzheimer Disease: Lauriet. Neurology. https://doi.org/10.1212/wnl.0000000000207663
Vancouver
Monteiro C, Toth B, Brunstein F, Bobbala A, Datta S, Ceniceros R, et al. Randomized Phase II Study of the Safety and Efficacy of Semorinemab in Participants With Mild-to-Moderate Alzheimer Disease: Lauriet. Neurology. 2023. doi:10.1212/wnl.0000000000207663. PMID: 37643887.
BibTeX
@article{monteiro2023-1c8f9366,
author = {Monteiro, C. and Toth, B. and Brunstein, F. and Bobbala, A. and Datta, S. and Ceniceros, R. and Sanabria Bohorquez, S. M. and Anania, V. G. and Wildsmith, K. R. and Schauer, S. P. and Lee, J. and Dolton, M. J. and Ramakrishnan, V. and Abramzon, D. and Teng, E. and {the Lauriet investigators}},
title = {{Randomized Phase II Study of the Safety and Efficacy of Semorinemab in Participants With Mild-to-Moderate Alzheimer Disease: Lauriet}},
journal = {Neurology},
year = {2023},
doi = {10.1212/wnl.0000000000207663},
pmid = {37643887},
url = {https://doi.org/10.1212/wnl.0000000000207663}
}
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record names 16 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.
Key findings
- 272 participants randomized across 43 global sites
- 42% slower decline on ADAS-Cog11 for semorinemab vs placebo at week 49
- No significant difference on the co-primary ADCS-ADL functional endpoint
- No effect on CDR-SB or MMSE secondary endpoints
- No measurable effect on tau-PET tracer signal despite target engagement
Why it matters
This trial tested an antibody targeting tau tangles rather than amyloid plaques, in people with mild-to-moderate Alzheimer's, and it slowed decline on one cognitive test by 42% compared with placebo, the first time an anti-tau antibody showed any cognitive benefit. However, it did not help with daily-function scores, overall dementia staging (CDR-SB), or the MMSE, and it did not reduce tangle buildup seen on tau brain scans.
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Study details
- Study designphase-2-trial
- Participants272
- Effect size42% slowing of decline on ADAS-Cog11 vs placebo at week 49; no significant difference on ADCS-ADL (co-primary), CDR-SB, MMSE, or tau-PET signal
- Evidence strengthPreliminary
Limitations
Mixed/discordant results across endpoints (benefit on one cognitive measure only) make the finding hard to interpret as a true treatment effect; no benefit on function or global staging, and no biomarker (tau-PET) confirmation of a disease-modifying mechanism.
How this study scored 69/100
Published in a leading specialty journal, and it is a mid-stage phase 2 trial. 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 and multicenter collaboration, so those were left out: it earned 44 of the 64 points we could judge it on, which is 69 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Neurology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 8 / 12 | A mid-stage phase 2 trial |
| Strength of evidence | 2 / 5 | Rated “preliminary” 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 | 2 / 4 | 272 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 | 1 / 2 | Randomized (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 |
| Multicenter collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 37643887) |
| Free to read | 2 / 2 | Free to read |
| Points | 44 / 64 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 44 of the 64 points we could judge it on is 69 out of 100. |
| Total | 69 / 100 | — |
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