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Japanese participant data from three gantenerumab trials in early Alzheimer's disease
Takashi Asada, Angeliki Thanasopoulou, Paul Delmar, Jakub Wojtowicz, Janice Smith, Yasumasa Yoshiyama, Katsunori Yokoi, Chigusa Watanabe et al.. Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025-04
Topic: Drug trials: efficacy and safety
Slowing of cognitive and functional decline, and amyloid reduction in gantenerumab group compared to placebo group were greater in Japanese-GRADUATE than in the global-GRADUATE and JP40959. Plasma gantenerumab concentrations in the Japanese-GRADUATE were slightly higher than in the global-GRADUATE and comparable to JP40959. Gantenerumab was well tolerated in the Japanese-GRADUATE and JP40959, matching the safety profile of the global-GRADUATE. Differences in results across the populations studied could be related to imbalances in baseline body weight, amyloid load, and disease severity. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID: NCT03444870, NCT03443973; Japan Registry for Clinical Trials ID: jRCT2080224569. HIGHLIGHTS: Gantenerumab was evaluated in Japanese participants with Alzheimer's disease (AD) in two global phase 3 trials and a phase 2 trial in Japan. Relative reduction in Clinical Dementia Rating Sum of Boxes (CDR-SB) deterioration favored gantenerumab in Japanese-GRADUATE (42%) more than in global-GRADUATE (9%) and JP40959 (-24%). Amyloid reduction in Japanese-GRADUATE was greater than in global-GRADUATE and JP40959. Overall, 72.7% and 27.5% of Japanese- and global-GRADUATE, respectively, achieved an amyloid-negative status. Cognitive and functional decline, and amyloid reduction could be related to baseline body weight and disease severity.
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APA 7th
Asada, T., Thanasopoulou, A., Delmar, P., Wojtowicz, J., Smith, J., Yoshiyama, Y., et al. (2025). Japanese participant data from three gantenerumab trials in early Alzheimer's disease. Alzheimer's & dementia : the journal of the Alzheimer's Association. https://doi.org/10.1002/alz.70192
Vancouver
Asada T, Thanasopoulou A, Delmar P, Wojtowicz J, Smith J, Yoshiyama Y, et al. Japanese participant data from three gantenerumab trials in early Alzheimer's disease. Alzheimer's & dementia : the journal of the Alzheimer's Association. 2025. doi:10.1002/alz.70192. PMID: 40302041.
BibTeX
@article{asada2025-40302041,
author = {Asada, Takashi and Thanasopoulou, Angeliki and Delmar, Paul and Wojtowicz, Jakub and Smith, Janice and Yoshiyama, Yasumasa and Yokoi, Katsunori and Watanabe, Chigusa and others},
title = {{Japanese participant data from three gantenerumab trials in early Alzheimer's disease}},
journal = {Alzheimer's \& dementia : the journal of the Alzheimer's Association},
year = {2025},
doi = {10.1002/alz.70192},
pmid = {40302041},
url = {https://doi.org/10.1002/alz.70192}
}
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Key findings
- Slowing of cognitive and functional decline, and amyloid reduction in gantenerumab group compared to placebo group were greater in Japanese-GRADUATE than in the global-GRADUATE and JP40959.
- Plasma gantenerumab concentrations in the Japanese-GRADUATE were slightly higher than in the global-GRADUATE and comparable to JP40959.
- Gantenerumab was well tolerated in the Japanese-GRADUATE and JP40959, matching the safety profile of the global-GRADUATE.
- Differences in results across the populations studied could be related to imbalances in baseline body weight, amyloid load, and disease severity.
- TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID: NCT03444870, NCT03443973; Japan Registry for Clinical Trials ID: jRCT2080224569.
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Study details
- Study designclinical trial
- Participants1,965
- Effect size72.7%; 27.5%
- Evidence strengthHigh
How this study scored 89/100
Published in a leading specialty journal, and it is a randomised controlled 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, multi-centre collaboration and free to read, so those were left out: it earned 50 of the 56 points we could judge it on, which is 89 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia : the journal of the Alzheimer's Association) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| 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 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 3 / 4 | 1,965 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 40302041) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 50 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 50 of the 56 points we could judge it on is 89 out of 100. |
| Total | 89 / 100 | — |
What each of these 20 components measures, and what this score is not →
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