ReviewThe Lancet regional health. Europe2026
Balancing benefit and risk in early Alzheimer's disease: the European Medicines Agency (EMA) assessment of lecanemab and donanemab.
Review in The Lancet regional health. Europe, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Class-level aggregation obscures clinically relevant heterogeneity in anti-amyloid antibody trials: comments on a Cochrane review by individual members of the EADC.The journal of prevention of Alzheimer's disease · 2026Article
- Article
- A Clinician View of the EMA Explanation of the Approval of Amyloid-Targeting Therapies.The Lancet regional health. Europe · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Alzheimer's disease (AD) remains the leading cause of dementia in Europe, with limited therapeutic options despite decades of research. Recent regulatory approvals of lecanemab and donanemab in the EU mark a significant milestone. Both antibodies, developed within the amyloid hypothesis, demonstrated statistically significant effects on cognitive and functional outcomes in patients with early AD, though the clinical meaningfulness of these effects remains debated. There are also important safety concerns, particularly amyloid-related imaging abnormalities (ARIA), which resulted in difficult benefit-risk assessments. The Personal View describes some of the lines of evidence considered by the European Medicines Agency in the assessment of efficacy of these medicines, and some of the measures to ensure their safe use. While these therapies do not halt disease progression, and have substantial risks, they represent a step toward more transformative treatments. Future research, including real-world evidence studies, should refine patient selection, optimise monitoring, and explore combination approaches and new targets to achieve improved outcomes.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.