{
  "abstract": "BACKGROUND: In the European Union (EU), donanemab is indicated in adults with early symptomatic Alzheimer's disease who are apolipoprotein E ε4 non-carriers or heterozygotes. Among these, patients without superficial siderosis at baseline, uncontrolled hypertension, or anticoagulant use are eligible. OBJECTIVE: To assess efficacy and safety of donanemab in the EU-eligible population. METHODS: A post-hoc conservative hybrid imputation method was implemented for clinical efficacy analyses during the TRAILBLAZER-ALZ 2 placebo-controlled period. In the 78-week long-term extension (LTE) participants in the early-start (randomised to donanemab) and delayed-start (randomised to placebo with donanemab initiation during the LTE) groups were compared to a propensity-weighted external control. Participants were switched to placebo after meeting amyloid-based treatment course completion criteria. RESULTS: By 76 weeks, donanemab-treated participants in the EU-eligible population had a mean Clinical Dementia Rating Scale (CDR)-Sum of Boxes change from baseline difference from placebo of -0.7 points (95% confidence interval, -1.0, -0.4) and a 40.3% lower risk of disease progression to the next stage (per CDR-Global score). Treatment benefit increased over 154 weeks for non-carriers and heterozygotes, including those meeting treatment course completion criteria by 52 or 76 weeks. In the placebo-controlled period, 119 (19.5%) and 49 (8.0%) donanemab-treated eligible participants experienced amyloid-related imaging abnormalities-edema/effusion and infusion-related reactions, respectively. Safety findings were similar among donanemab-treated participants in the placebo-controlled period and LTE delayed-start group. CONCLUSIONS: Consistent with previous TRAILBLAZER-ALZ 2 and LTE findings, donanemab significantly slowed disease progression compared to controls with a manageable safety profile in non-carriers and heterozygotes.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Psychiatry, Medical Faculty, University of Cologne, Cologne, Germany; German Center for Neurodegenerative Diseases, Bonn, Germany; Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, University of Cologne, Cologne, Germany",
    "Eli Lilly and Company, Indianapolis, IN, USA",
    "Unit of Neurology and Neuroimaging of Neurodegenerative Diseases, IRCCS Ospedale San Raffaele, Milano, Italy; \"Vita-Salute San Raffaele\" University, Milano, Italy"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 13,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Frank Jessen",
      "orcid": "0000-0003-1067-2102"
    },
    {
      "affs": [
        1
      ],
      "name": "Grazia Dell’Agnello",
      "orcid": "0000-0002-5482-6065"
    },
    {
      "affs": [
        1
      ],
      "name": "Jennifer A. Zimmer"
    },
    {
      "affs": [
        1
      ],
      "name": "Christophe Sapin",
      "orcid": "0000-0001-7655-7129"
    },
    {
      "affs": [
        1
      ],
      "name": "Sascha Dichter"
    },
    {
      "affs": [
        1
      ],
      "name": "Erin Gautier Doty",
      "orcid": "0000-0003-1400-4427"
    },
    {
      "affs": [
        1
      ],
      "name": "Stéphane Epelbaum",
      "orcid": "0000-0003-4059-2891"
    },
    {
      "affs": [
        1
      ],
      "name": "Cynthia Duggan Evans"
    },
    {
      "affs": [
        1
      ],
      "name": "Paula M. Hauck",
      "orcid": "0000-0002-2889-235X"
    },
    {
      "affs": [
        1
      ],
      "name": "Rashna Khanna",
      "orcid": "0000-0002-3728-7987"
    },
    {
      "affs": [
        1
      ],
      "name": "Dawn A. Brooks",
      "orcid": "0009-0004-2009-0493"
    },
    {
      "affs": [
        1
      ],
      "name": "John Randall Sims",
      "orcid": "0009-0009-5090-7886"
    },
    {
      "affs": [
        2
      ],
      "name": "Federica Agosta",
      "orcid": "0000-0003-3121-4979"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/3sgffmsnxs2xn.bib",
  "cited_by": 5,
  "doi": "10.1016/j.tjpad.2026.100605",
  "fulltext_url": null,
  "id": "3sgffmsnxs2xn",
  "issns": [
    "2274-5807",
    "2426-0266"
  ],
  "landing_url": "https://doi.org/10.1016/j.tjpad.2026.100605",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2804|Alzheimer's disease research and treatments"
    ]
  ],
  "openalex": "W7162521783",
  "pdf_url": null,
  "pmcid": "PMC13234467",
  "pmid": "42202469",
  "published": "2026-05-27",
  "publisher": "Springer Science+Business Media",
  "ris": "https://research.draconitic.com/paper/3sgffmsnxs2xn.ris",
  "sources": [
    {
      "first_seen": "2026-11-07T13:20:56Z",
      "native_id": "W7162521783",
      "source": "openalex",
      "url": "https://doi.org/10.1016/j.tjpad.2026.100605"
    }
  ],
  "subjects": [
    {
      "field": "biology",
      "origin": "openalex:2804|Alzheimer's disease research and treatments",
      "subfield": "neuroscience"
    }
  ],
  "title": "Efficacy and safety of donanemab in the European eligible population: TRAILBLAZER-ALZ 2 post-hoc analyses",
  "title_text": "Efficacy and safety of donanemab in the European eligible population: TRAILBLAZER-ALZ 2 post-hoc analyses",
  "type": "peer-reviewed",
  "updated_at": "2026-11-09T13:21:14Z",
  "url": "https://research.draconitic.com/paper/3sgffmsnxs2xn",
  "venue": "The Journal of Prevention of Alzheimer s Disease",
  "versions": []
}