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Donanemab in preclinical Alzheimer's disease: Screening and baseline data from TRAILBLAZER-ALZ 3
Roy Yaari, Karen C Holdridge, Melissa Williamson, Alette M Wessels, Sergey Shcherbinin, Vikas Kotari, Eric M Reiman, Pierre N Tariot et al.. Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025-09
Topic: Drug trials: efficacy and safety
Participants 55-80 years of age were screened (N = 63,124). Plasma p-tau217-eligible participants were enrolled (N = 2196), with Clinical Dementia Rating (CDR) scale-Global score (CDR-GS) of 0 (n = 1202) and 0.5 (n = 664). Plasma p-tau217 eligibility increased with age, differing across races and ethnicities. Mean baseline amyloid levels were 63.2 (CDR-GS: 0) and 70.7 Centiloids (CDR-GS: 0.5). Elevated global tau signal (standardized uptake value ratio ≥1.10) was observed in 15.1% and 26.3% of CDR-GS 0 and 0.5 subgroups, respectively. Utilizing a unique decentralized design, the trial showed baseline data consistent with preclinical AD. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05026866, TRAILBLAZER-ALZ 3 HIGHLIGHTS: TRAILBLAZER-ALZ 3 screened 63,124 participants in the United States and Japan Plasma phosphorylated tau-217 (p-tau217) was used to determine Alzheimer's disease pathology for eligibility A decentralized model was used, including remote raters for clinical testing Randomized participants had Clinical Dementia Rating scale-Global scores of 0 and 0.5.
Key findings
- Participants 55-80 years of age were screened (N = 63,124).
- Plasma p-tau217-eligible participants were enrolled (N = 2196), with Clinical Dementia Rating (CDR) scale-Global score (CDR-GS) of 0 (n = 1202) and 0.5 (n = 664).
- Plasma p-tau217 eligibility increased with age, differing across races and ethnicities.
- Mean baseline amyloid levels were 63.2 (CDR-GS: 0) and 70.7 Centiloids (CDR-GS: 0.5).
- Elevated global tau signal (standardized uptake value ratio ≥1.10) was observed in 15.1% and 26.3% of CDR-GS 0 and 0.5 subgroups, respectively.
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Study details
- Study designlongitudinal study
- Participants63,124
- Effect size15.1%; 26.3%
- Evidence strengthHigh
How this study scored 91/100
Published in a leading specialty 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, multi-centre collaboration and free to read, so those were left out: it earned 51 of the 56 points we could judge it on, which is 91 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 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 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 4 / 4 | 63,124 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 40955720) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 51 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 51 of the 56 points we could judge it on is 91 out of 100. |
| Total | 91 / 100 | — |
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APA 7th
Yaari, R., Holdridge, K. C., Williamson, M., Wessels, A. M., Shcherbinin, S., Kotari, V., et al. (2025). Donanemab in preclinical Alzheimer's disease: Screening and baseline data from TRAILBLAZER-ALZ 3. Alzheimer's & dementia : the journal of the Alzheimer's Association. https://doi.org/10.1002/alz.70662
Vancouver
Yaari R, Holdridge KC, Williamson M, Wessels AM, Shcherbinin S, Kotari V, et al. Donanemab in preclinical Alzheimer's disease: Screening and baseline data from TRAILBLAZER-ALZ 3. Alzheimer's & dementia : the journal of the Alzheimer's Association. 2025. doi:10.1002/alz.70662. PMID: 40955720.
BibTeX
@article{yaari2025-40955720,
author = {Yaari, Roy and Holdridge, Karen C and Williamson, Melissa and Wessels, Alette M and Shcherbinin, Sergey and Kotari, Vikas and Reiman, Eric M and Tariot, Pierre N and others},
title = {{Donanemab in preclinical Alzheimer's disease: Screening and baseline data from TRAILBLAZER-ALZ 3}},
journal = {Alzheimer's \& dementia : the journal of the Alzheimer's Association},
year = {2025},
doi = {10.1002/alz.70662},
pmid = {40955720},
url = {https://doi.org/10.1002/alz.70662}
}