Donanemab eligibility in early Alzheimer's disease: A real-world study
This study evaluates the real-world eligibility of patients with early Alzheimer's disease (AD) for donanemab, a monoclonal antibody targeting amyloid plaques. At a tertiary center in Italy, 408 patients with mild cognitive impairment (MCI) or mild AD were assessed against clinical trial criteria. While 41% were amyloid-positive, only 10.05% met eligibility for treatment, primarily due to exclusions for amyloid biomarkers, medical conditions, and MRI findings. These results highlight the gap between trial populations and real-world patients. Balancing efficacy with safety remains a key challenge in expanding access to anti-AD immunotherapy like donanemab in routine clinical practice.
Authors
- Alessia Giugno (ORCID: https://orcid.org/0000-0002-9366-1582)
- Daniele Urso (ORCID: https://orcid.org/0000-0002-4503-0110)
- Stefano Giannoni‐Luza (ORCID: https://orcid.org/0000-0001-7413-4501)
- Alessandro Introna (ORCID: https://orcid.org/0000-0002-3141-6442)
- Giancarlo Logroscino (ORCID: https://orcid.org/0000-0003-0423-3242)
- Davide Vilella (ORCID: https://orcid.org/0009-0008-5319-7050)
- Valentina Gnoni (ORCID: https://orcid.org/0000-0003-3181-0842)
- Chiara Zecca (ORCID: https://orcid.org/0000-0002-7855-5714)
- Roberto De Blasi (ORCID: https://orcid.org/0000-0002-8556-8572)
Institutions
- Ferioli & Gianotti (Italy) (IT)
- University of Bari Aldo Moro (IT)
Publication Details
- Journal
- Journal of Alzheimer s Disease
- Published
- 2025-05-01
- DOI
- https://doi.org/10.1177/13872877251331243
- Citations
- 7
- Primary Topic
- Alzheimer's disease research and treatments
- Type
- article
- Field-Weighted Citation Impact
- 8.15