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April 24, 2023

Advocating for Demonstration of Disease Modification—Have We Been Approaching Clinical Trials in Early Alzheimer Disease Incorrectly?

Author Affiliations
  • 1Centre National de la Recherche Scientifique, Université de Bordeaux, Institut des Maladies Neurodégéneratives, Bordeaux, France
  • 2Centre Mémoire Ressources Recherches, Pôle de Neurosciences Cliniques, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
  • 3AP-HP.Sorbonne Université, Institut de la Mémoire et de la Maladie d’Alzheimer, Département de Neurologie, Hôpital Pitié-Salpêtrière, Paris, France
  • 4Sorbonne Université, Institut national de la Santé et de la Recherche Medical (INSERM) U1127, Centre National de la Recherche Scientifique (CNRS) 7225, Institut du Cerveau—ICM, Paris, France
JAMA Neurol. Published online April 24, 2023. doi:10.1001/jamaneurol.2023.0815

The Alzheimer disease (AD) community was unanimous in welcoming the favorable results of Clarity AD,1 an 18-month phase 3 randomized clinical trial of lecanemab in early AD (defined as mild cognitive impairment or mild dementia due to AD). For the first time, an antiamyloid immunotherapy showed an indisputable clinical benefit. Eventually, lecanemab received accelerated approval by the US Food and Drug Administration.

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