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Higher phosphorylated tau levels predict cognitive decline and amyloid-related imaging abnormalities during lecanemab treatment: clinical practice data
Noguchi-Shinohara M, Yoshinobu T, Ozaki T, Muramatsu D, Shima A, Sakashita Y, Tada Y, Yamaguchi H et al.. Alzheimer's research & therapy, 2025-11-24
Topic: Plasma and spinal-fluid biomarkers
Background Lecanemab was recently approved for the treatment of patients with early Alzheimer's disease (AD) and demonstrated reduced senile amyloid plaque and less decline on the measures of cognition and function in clinical trials. However, the real-world data on its efficacy and safety remain limited. We aimed to evaluate the effectiveness and tolerance of lecanemab treatment and determine biomarkers at baseline that could predict cognitive deterioration and the occurrence of amyloid-related imaging abnormaities (ARIA) in real-world clinical practice. Methods To determine the indication for lecanemab, the patients were evaluated through neurological examinations, cognitive assessments, blood test, head magnetic resonance imaging (MRI), amyloid positron emission tomography, lumbar puncture, genetic testing, and clinical conferences. The Mini-Mental State Examination (MMSE) was used to assess cognition, and the MRI scans were used for safety monitoring of ARIA. Results Between January 2024 and October 2025, 234 patients were screened, 100 initiated lecanemab treatment. The mean age was 72.7 years, and 68 (68.0%) patients were female. Among the 71 patients surveyed via MRI prior to the 14th infusion, 12 (16.9%) had ARIA detected. Compared with those of patients without ARIA, the baseline cerebrospinal fluid (CSF)-ptau181 levels of patients with ARIA significantly increased. When the patients were divided into high and low CSF-ptau181 groups according to the cutoff value (78.6 pg/ml) which derived from ROC analysis for ARIA prediction, the MMSE scores of the high ptau group were significantly declined compared to that of the low ptau group at 6 and 12 months after baseline. The infusion-reactions occurred only in 6.0% of patients. The longitudinal observation revealed that the plasma thrombomodulin levels significantly decreased after 6 months of lecanemab treatment. Conclusion Lecanemab was generally well tolerated by most patients with early AD and treatment appeared to be more effective and safer in patients with low CSF-ptau181 levels. Our results suggest an association between lecanemab treatment and reduced markers of vascular endothelial injury.
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APA 7th
Noguchi-Shinohara, M., Yoshinobu, T., Ozaki, T., Muramatsu, D., Shima, A., Sakashita, Y., et al. (2025). Higher phosphorylated tau levels predict cognitive decline and amyloid-related imaging abnormalities during lecanemab treatment: clinical practice data. Alzheimer's research & therapy. https://doi.org/10.1186/s13195-025-01912-6
Vancouver
Noguchi-Shinohara M, Yoshinobu T, Ozaki T, Muramatsu D, Shima A, Sakashita Y, et al. Higher phosphorylated tau levels predict cognitive decline and amyloid-related imaging abnormalities during lecanemab treatment: clinical practice data. Alzheimer's research & therapy. 2025. doi:10.1186/s13195-025-01912-6. PMID: 41276859.
BibTeX
@article{noguchishinohara2025-41276859,
author = {Noguchi-Shinohara, M. and Yoshinobu, T. and Ozaki, T. and Muramatsu, D. and Shima, A. and Sakashita, Y. and Tada, Y. and Yamaguchi, H. and others},
title = {{Higher phosphorylated tau levels predict cognitive decline and amyloid-related imaging abnormalities during lecanemab treatment: clinical practice data}},
journal = {Alzheimer's research \& therapy},
year = {2025},
doi = {10.1186/s13195-025-01912-6},
pmid = {41276859},
url = {https://doi.org/10.1186/s13195-025-01912-6}
}
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Key findings
- Background Lecanemab was recently approved for the treatment of patients with early Alzheimer's disease (AD) and demonstrated reduced senile amyloid plaque and less decline on the measures of cognition and function in clinical trials.
- Results Between January 2024 and October 2025, 234 patients were screened, 100 initiated lecanemab treatment.
- Compared with those of patients without ARIA, the baseline cerebrospinal fluid (CSF)-ptau181 levels of patients with ARIA significantly increased.
- When the patients were divided into high and low CSF-ptau181 groups according to the cutoff value (78.6 pg/ml) which derived from ROC analysis for ARIA prediction, the MMSE scores of the high ptau group were significantly declined compared to that of the low ptau group at 6 and 12 months after baseline.
- The longitudinal observation revealed that the plasma thrombomodulin levels significantly decreased after 6 months of lecanemab treatment.
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Study details
- Study designlongitudinal study
- Participants234
- Effect size68.0%; 16.9%; 6.0%
- Evidence strengthModerate
How this study scored 72/100
Published in a peer-reviewed journal, and it is a longitudinal study following the same people over time. Scored zero for 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 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 (Alzheimer's research & therapy) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 7 / 12 | A longitudinal study following the same people over time |
| 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 | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 2 / 4 | 234 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 | 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 41276859) |
| 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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