Evidence map›Paper›PMID 41355080›Full record

Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2025

Long-term safety and efficacy of lecanemab in early Alzheimer's disease: Results from the clarity AD open-label extension study.

Christopher H van Dyck, Reisa Sperling, Keith Johnson, Shobha Dhadda, Michio Kanekiyo, David Li, Michelle Gee, Steven Hersch, Michael Irizarry, Lynn Kramer

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Regulatory, clinical, and post-marketing challenges of lecanemab for Alzheimer's disease: insights from real-world data.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. The value of timely treatment with anti-amyloid therapy for Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  6. Amyloid-beta-targeting monoclonal antibodies in early Alzheimer's disease: a cochrane review summary and appraisal for the neurological community.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Beyond the Cochrane review: Re-evaluating anti-amyloid therapy in Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  12. Article
  13. Further data to address the Alzheimer's coverage with evidence development questions.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Review
  14. Article
  15. What should convince a clinician of disease modification in Alzheimer's disease clinical trials?Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Review
  16. Article
  17. Review
  18. Article
  19. Lecanemab use for early Alzheimer disease in Canada.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2026
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Christopher H van DyckAlzheimer's Disease Research Unit, Yale University School of Medicine, New Haven, Connecticut, USA.
Reisa SperlingBrigham and Women's Hospital, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Keith JohnsonMassachusetts General Hospital, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Shobha DhaddaDeep Human Biology Learning (DHBL), Neurology, Eisai Inc. Nutley, New Jersey, USA.
Michio KanekiyoDeep Human Biology Learning (DHBL), Neurology, Eisai Inc. Nutley, New Jersey, USA.
David LiDeep Human Biology Learning (DHBL), Neurology, Eisai Inc. Nutley, New Jersey, USA.
Michelle GeeDeep Human Biology Learning (DHBL), Neurology, Eisai Ltd., Hatfield, UK.
Steven HerschDeep Human Biology Learning (DHBL), Neurology, Eisai Inc. Nutley, New Jersey, USA.
Michael IrizarryDeep Human Biology Learning (DHBL), Neurology, Eisai Inc. Nutley, New Jersey, USA.
Lynn KramerDeep Human Biology Learning (DHBL), Neurology, Eisai Inc. Nutley, New Jersey, USA.

Funding

Eisai Inc. and Biogen
6 · The paper itself

Abstract

introductionIn Clarity AD, lecanemab reduced markers of amyloid in early symptomatic Alzheimer's disease and slowed cognitive and functional decline at 18 months. Herein, we report 36-month data from the ongoing open-label extension (OLE).

methodsClarity AD is an 18-month, randomized study (Core), with an OLE where participants received open-label lecanemab. Clinical and health-related quality-of-life (HRQoL) outcomes were evaluated overall and by examining "delayed-start" and "early-start" cohorts. Low pathology (i.e., low baseline amyloid or tau) subgroups were analyzed.

resultsARIA rates were low after 6 months and not associated with long-term progression. Across clinical and HRQoL endpoints, lecanemab-treated participants continued to benefit through 36 months. Separation between early and delayed start was maintained between 18 and 36 months. The low pathology subgroup showed stability or improvement over 18-36 months. DISCUSSION: Benefit continued to accrue with ongoing lecanemab treatment through 36 months. Results in the low pathology subgroup support early initiation of lecanemab treatment. HIGHLIGHTS: This research evaluated the long-term efficacy, safety, and HRQoL results from an ongoing extension of the phase 3 Clarity AD, which included open-label lecanemab treatment for up to 36 months. Overall, the results show participants continue to accrue a lecanemab treatment benefit up to 36 months and highlight the importance of continued long-term lecanemab treatment. Results presented in our paper demonstrate that lecanemab continued suppression of amyloid plaque levels and significantly slowed clinical decline on multiple measures of cognition, function, and quality of life in early AD at 18 months and continued for 36 months to date. No new safety signals were observed with continued lecanemab treatment. After the first 6 months, ARIA rates were low and similar to ARIA rates on placebo, with no association between ARIA occurrence and accelerated long-term clinical progression. Taken together with existing data, these results provide a clear rationale and a demonstration of the disease modification effects of long-term lecanemab therapy.

Indexed as

Alzheimer DiseaseAgedAged, 80 and overAmyloid beta-PeptidesDisease ProgressionFemaleHumansMaleQuality of LifeTreatment OutcomeAmyloid beta-Peptidesearly Alzheimer's diseaselecanemab treatmentlong‐term safety and efficacy

Identifiers

PMID41355080
PMCPMC12682705

What OpenQuestion holds

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Registered trials

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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.