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Donanemab: Appropriate use recommendations
Rabinovici GD, Selkoe DJ, Schindler SE, Aisen P, Apostolova LG, Atri A, Greenberg SM, Hendrix SB et al.. The journal of prevention of Alzheimer's disease, 2025-03-27
Topic: Risk, prevention and care in population studies
Donanemab (Kisunla®), an IgG1 monoclonal antibody targeting N-terminal pyroglutamate-modified forms of amyloid-β, is approved in the United States for treatment of early symptomatic Alzheimer's disease (AD). Appropriate Use Recommendations (AUR) were developed to guide the implementation of donanemab in real-world practice, prioritizing safety considerations and opportunity for effectiveness. The AUR were developed by the AD and Related Disorders Therapeutic Workgroup by consensus, integrating available data and expert opinion.
Key findings
- Appropriate Use Recommendations (AUR) were developed to guide the implementation of donanemab in real-world practice, prioritizing safety considerations and opportunity for effectiveness.
- The AUR were developed by the AD and Related Disorders Therapeutic Workgroup by consensus, integrating available data and expert opinion.
- Appropriate candidates for donanemab treatment include persons with mild cognitive impairment or mild dementia due to AD (Clinical Stages 3-4, MMSE 20-30) who have biomarker confirmation of AD pathology by PET or CSF.
- Apolipoprotein E (APOE) genotyping should be performed prior to treatment to inform an individual's risk of developing Amyloid-Related Imaging Abnormalities (ARIA).
Why it matters
These expert consensus recommendations from the AD and Related Disorders Therapeutic Workgroup set out who should be considered for donanemab (Kisunla) in US practice: people with mild cognitive impairment or mild dementia due to Alzheimer's (MMSE 20-30) whose Alzheimer's pathology has been confirmed by PET or spinal-fluid (CSF) testing. They also advise APOE gene testing before treatment to gauge a person's risk of ARIA, a brain-imaging side effect. This is guidance on using an approved drug safely, built from existing data and expert opinion, not new evidence of how well it works.
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Study details
- Evidence strengthLow
How this study scored 58/100
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.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The journal of prevention of Alzheimer's disease) |
| Journal's citation record | 0 / 4 | The Journal of Prevention of Alzheimer s Disease: journal h-index 63 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” 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 | 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 | 5 / 7 | Cited 248 times (OpenAlex, 2026-10-10) |
| Citations per year | 5 / 5 | 82.7 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 6 / 6 | Cited 135.6× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 4 / 6 | Cited by 30 other studies in this library |
| Still being cited | 4 / 4 | Cited 248 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Jeffrey L. Cummings: h-index 35 (OpenAlex, whole career) |
| Institution's track record | 3 / 3 | Harvard University: institution h-index 3,235 (OpenAlex) |
| Multi-centre collaboration | 3 / 3 | OpenAlex lists 14 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40155270) |
| Free to read | 2 / 2 | Free to read |
| Total | 58 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1016/j.tjpad.2025.100150
- PubMed: 40155270
- Original source →
- Free full text: The Journal of Prevention of Alzheimer s Disease →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
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
Rabinovici, G. D., Selkoe, D. J., Schindler, S. E., Aisen, P., Apostolova, L. G., Atri, A., et al. (2025). Donanemab: Appropriate use recommendations. The journal of prevention of Alzheimer's disease. https://doi.org/10.1016/j.tjpad.2025.100150
Vancouver
Rabinovici GD, Selkoe DJ, Schindler SE, Aisen P, Apostolova LG, Atri A, et al. Donanemab: Appropriate use recommendations. The journal of prevention of Alzheimer's disease. 2025. doi:10.1016/j.tjpad.2025.100150. PMID: 40155270.
BibTeX
@article{rabinovici2025-40155270,
author = {Rabinovici, G. D. and Selkoe, D. J. and Schindler, S. E. and Aisen, P. and Apostolova, L. G. and Atri, A. and Greenberg, S. M. and Hendrix, S. B. and others},
title = {{Donanemab: Appropriate use recommendations}},
journal = {The journal of prevention of Alzheimer's disease},
year = {2025},
doi = {10.1016/j.tjpad.2025.100150},
pmid = {40155270},
url = {https://doi.org/10.1016/j.tjpad.2025.100150}
}
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