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Donanemab (LY3002813) dose‐escalation study in Alzheimer's disease
Stephen Loucian Lowe, Brian A. Willis, Anne Hawdon, Fanni Natanegara, Laiyi Chua, Joanne Foster, Sergey Shcherbinin, Paul Ardayfio et al.. Alzheimer's & Dementia: Translational Research & Clinical Interventions, 2021-01
Topic: Drug trials: efficacy and safety
Donanemab was generally well tolerated up to 10 mg/kg. After single‐dose administration from 0.1 to 3.0 mg/kg, the mean terminal elimination half‐life was ≈4 days, increasing to ≈10 days at 10 mg/kg. Only the 10‐mg/kg dose showed changes in amyloid positron emission tomography. Amyloid reduction of 40% to 50% was achieved. Approximately 90% of subjects developed anti‐drug antibodies at 3 months after a single intravenous dose. Intravenous donanemab 10 mg/kg can reduce amyloid deposits in AD despite having a shorter than expected half‐life.
Key findings
- Donanemab was generally well tolerated up to 10 mg/kg.
- After single‐dose administration from 0.1 to 3.0 mg/kg, the mean terminal elimination half‐life was ≈4 days, increasing to ≈10 days at 10 mg/kg.
- Only the 10‐mg/kg dose showed changes in amyloid positron emission tomography.
- Amyloid reduction of 40% to 50% was achieved.
- Approximately 90% of subjects developed anti‐drug antibodies at 3 months after a single intravenous dose.
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Study details
- Evidence strengthModerate
How this study scored 43/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and 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, multi-centre collaboration and free to read, so those were left out: it earned 24 of the 56 points we could judge it on, which is 43 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Alzheimer's & Dementia: Translational Research & Clinical Interventions) |
| 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 | 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 | 3 / 5 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| 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 | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 24 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 24 of the 56 points we could judge it on is 43 out of 100. |
| Total | 43 / 100 | — |
What each of these 20 components measures, and what this score is not →
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Lowe, S. L., Willis, B. A., Hawdon, A., Natanegara, F., Chua, L., Foster, J., et al. (2021). Donanemab (LY3002813) dose‐escalation study in Alzheimer's disease. Alzheimer's & Dementia: Translational Research & Clinical Interventions. https://doi.org/10.1002/trc2.12112
Vancouver
Lowe SL, Willis BA, Hawdon A, Natanegara F, Chua L, Foster J, et al. Donanemab (LY3002813) dose‐escalation study in Alzheimer's disease. Alzheimer's & Dementia: Translational Research & Clinical Interventions. 2021. doi:10.1002/trc2.12112.
BibTeX
@article{lowe2021-3ffcda2a,
author = {Lowe, Stephen Loucian and Willis, Brian A. and Hawdon, Anne and Natanegara, Fanni and Chua, Laiyi and Foster, Joanne and Shcherbinin, Sergey and Ardayfio, Paul and others},
title = {{Donanemab (LY3002813) dose‐escalation study in Alzheimer's disease}},
journal = {Alzheimer's \& Dementia: Translational Research \& Clinical Interventions},
year = {2021},
doi = {10.1002/trc2.12112},
url = {https://doi.org/10.1002/trc2.12112}
}
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