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Donanemab in Early Symptomatic Alzheimer’s Disease: Efficacy and Safety in TRAILBLAZER‐ALZ 2, a Phase 3 Randomized Clinical Trial
Mark A. Mintun, Craig William Ritchie, Paul R. Solomon, John Randall Sims, Stephen Salloway, Oskar Hansson, Liana G. Apostolova, Jennifer A. Zimmer et al.. Alzheimer s & Dementia, 2023-12-01
Topic: Drug trials: efficacy and safety
Background In TRAILBLAZER‐ALZ, donanemab cleared brain amyloid plaques and significantly slowed disease progression in early symptomatic Alzheimer’s disease (AD). Results In the low/medium‐tau population, change in iADRS score at 76w was ‐6.02 with donanemab and ‐9.27 with placebo (difference, 3.25; 95% CI, 1.88 to 4.62; P <0.001), representing a 35.1% slowing of disease progression. Participants receiving donanemab experienced a 38.6% lower risk of progressing to the next disease stage versus placebo over 76w (CDR‐Global score, Hazard Ratio = 0.61; P <0.001). Plasma P‐tau217 was significantly reduced by 39.3% from baseline with donanemab and increased by 8.4% with placebo at 76w ( P <0.001). Significant, positive results across all clinical endpoints were also observed in the combined population. Conclusion Donanemab treatment significantly slowed clinical progression at 76w and had a safety profile consistent with earlier studies.
Key findings
- Background In TRAILBLAZER‐ALZ, donanemab cleared brain amyloid plaques and significantly slowed disease progression in early symptomatic Alzheimer’s disease (AD).
- Results In the low/medium‐tau population, change in iADRS score at 76w was ‐6.02 with donanemab and ‐9.27 with placebo (difference, 3.25; 95% CI, 1.88 to 4.62; P <0.001), representing a 35.1% slowing of disease progression.
- Participants receiving donanemab experienced a 38.6% lower risk of progressing to the next disease stage versus placebo over 76w (CDR‐Global score, Hazard Ratio = 0.61; P <0.001).
- Plasma P‐tau217 was significantly reduced by 39.3% from baseline with donanemab and increased by 8.4% with placebo at 76w ( P <0.001).
- Significant, positive results across all clinical endpoints were also observed in the combined population.
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Study details
- Participants1,182
- Effect size35.1%; 36.0%; 38.6%
- Evidence strengthHigh
How this study scored 64/100
Published in a peer-reviewed journal. Scored zero for study design 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 37 of the 58 points we could judge it on, which is 64 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Alzheimer s & Dementia) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| 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 | 3 / 5 | 2023 — within 6 year(s) of the newest study here |
| Sample size | 3 / 4 | 1,182 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 | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | 2 / 2 | Free to read |
| Points | 37 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 37 of the 58 points we could judge it on is 64 out of 100. |
| Total | 64 / 100 | — |
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APA 7th
Mintun, M. A., Ritchie, C. W., Solomon, P. R., Sims, J. R., Salloway, S., Hansson, O., et al. (2023). Donanemab in Early Symptomatic Alzheimer’s Disease: Efficacy and Safety in TRAILBLAZER‐ALZ 2, a Phase 3 Randomized Clinical Trial. Alzheimer s & Dementia. https://doi.org/10.1002/alz.082733
Vancouver
Mintun MA, Ritchie CW, Solomon PR, Sims JR, Salloway S, Hansson O, et al. Donanemab in Early Symptomatic Alzheimer’s Disease: Efficacy and Safety in TRAILBLAZER‐ALZ 2, a Phase 3 Randomized Clinical Trial. Alzheimer s & Dementia. 2023. doi:10.1002/alz.082733.
BibTeX
@article{mintun2023-3d9d0576,
author = {Mintun, Mark A. and Ritchie, Craig William and Solomon, Paul R. and Sims, John Randall and Salloway, Stephen and Hansson, Oskar and Apostolova, Liana G. and Zimmer, Jennifer A. and others},
title = {{Donanemab in Early Symptomatic Alzheimer’s Disease: Efficacy and Safety in TRAILBLAZER‐ALZ 2, a Phase 3 Randomized Clinical Trial}},
journal = {Alzheimer s \& Dementia},
year = {2023},
doi = {10.1002/alz.082733},
url = {https://doi.org/10.1002/alz.082733}
}