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. 2025 Jun;105(3):745-750.
doi: 10.1177/13872877251331243. Epub 2025 May 1.

Donanemab eligibility in early Alzheimer's disease: A real-world study

Daniele Urso  1 , Alessandro Introna  2 , Valentina Gnoni  1 , Alessia Giugno  1 , Davide Vilella  1 , Chiara Zecca  1 , Roberto De Blasi  3 , Stefano Giannoni-Luza  1 , Giancarlo Logroscino  1   2
Affiliations

Donanemab eligibility in early Alzheimer's disease: A real-world study

Daniele Urso et al. J Alzheimers Dis. 2025 Jun.

Abstract

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.

Keywords: Alzheimer's disease; donanemab; eligibility; immunotherapy.

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Conflict of interest statement

Declaration of conflicting interestsGiancarlo Logroscino has served as investigator for clinical trials sponsored by Biogen Pharmaceuticals, Axovant, Alector, Denali, Roche, Eisai, Genentech, Amylyx, PIAM Farmaceutici SpA.He has served as a consultant and has given Lectures for EISAI, Roche, Lilly, Piam Farmaceutici Spa, Biogen. Daniele Urso is an Editorial Board Member of this journal but was not involved in the peer-review process of this article nor had access to any information regarding its peer-review. The remaining authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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