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Japanese Subgroup Analyses from EMERGE and ENGAGE, Phase 3 Clinical Trials of Aducanumab in Patients with Early Alzheimer's Disease
Toda Y, Iwatsubo T, Nakamura Y, Matsuda N, Miyata M, Jin M, Chen T, Kuribayashi K et al.. The journal of prevention of Alzheimer's disease, 2024-01-01
Topic: Drug trials: efficacy and safety
Results Results from the Japanese subgroup analyses were generally consistent with those of the overall study population across endpoints, while a lower mean body weight (kg) and a smaller proportion of ApoE ε4 carriers were observed in the Japanese subgroup population. The incidence and type of adverse events in the Japanese subgroups were generally comparable to those observed in the overall study population; amyloid related imaging abnormalities (ARIA) were common treatment-related adverse events that appeared to be related to the aducanumab dose. ARIA incidence was generally lower in the Japanese subgroup compared with the overall population. Consistent with the overall data set, a robust dose-dependent decrease in amyloid beta levels as assessed with amyloid-PET and plasma p-tau181 was observed. Conclusion Efficacy, safety, biomarker, and PK profiles of aducanumab were consistent between the Japanese subgroup and the overall population.
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APA 7th
Toda, Y., Iwatsubo, T., Nakamura, Y., Matsuda, N., Miyata, M., Jin, M., et al. (2024). Japanese Subgroup Analyses from EMERGE and ENGAGE, Phase 3 Clinical Trials of Aducanumab in Patients with Early Alzheimer's Disease. The journal of prevention of Alzheimer's disease. https://doi.org/10.14283/jpad.2024.106
Vancouver
Toda Y, Iwatsubo T, Nakamura Y, Matsuda N, Miyata M, Jin M, et al. Japanese Subgroup Analyses from EMERGE and ENGAGE, Phase 3 Clinical Trials of Aducanumab in Patients with Early Alzheimer's Disease. The journal of prevention of Alzheimer's disease. 2024. doi:10.14283/jpad.2024.106. PMID: 39350371.
BibTeX
@article{toda2024-39350371,
author = {Toda, Y. and Iwatsubo, T. and Nakamura, Y. and Matsuda, N. and Miyata, M. and Jin, M. and Chen, T. and Kuribayashi, K. and others},
title = {{Japanese Subgroup Analyses from EMERGE and ENGAGE, Phase 3 Clinical Trials of Aducanumab in Patients with Early Alzheimer's Disease}},
journal = {The journal of prevention of Alzheimer's disease},
year = {2024},
doi = {10.14283/jpad.2024.106},
pmid = {39350371},
url = {https://doi.org/10.14283/jpad.2024.106}
}
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Key findings
- Results Results from the Japanese subgroup analyses were generally consistent with those of the overall study population across endpoints, while a lower mean body weight (kg) and a smaller proportion of ApoE ε4 carriers were observed in the Japanese subgroup population.
- The incidence and type of adverse events in the Japanese subgroups were generally comparable to those observed in the overall study population; amyloid related imaging abnormalities (ARIA) were common treatment-related adverse events that appeared to be related to the aducanumab dose.
- ARIA incidence was generally lower in the Japanese subgroup compared with the overall population.
- Consistent with the overall data set, a robust dose-dependent decrease in amyloid beta levels as assessed with amyloid-PET and plasma p-tau181 was observed.
- Conclusion Efficacy, safety, biomarker, and PK profiles of aducanumab were consistent between the Japanese subgroup and the overall population.
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Study details
- Study designclinical trial
- Participants121
- Effect size7.4%; 6.1%
- Evidence strengthHigh
How this study scored 84/100
Published in a peer-reviewed journal, and it is a large phase 3 trial. 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 49 of the 58 points we could judge it on, which is 84 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The journal of prevention of Alzheimer's disease) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A large phase 3 trial (from PubMed type “Clinical Trial, Phase III”) |
| 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 | 2024 — within 3 year(s) of the newest study here |
| Sample size | 2 / 4 | 121 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 | — / 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 39350371) |
| Free to read | 2 / 2 | Free to read |
| Points | 49 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 49 of the 58 points we could judge it on is 84 out of 100. |
| Total | 84 / 100 | — |
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