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CTAD 2022 | Is amyloid load a valid surrogate endpoint for AD clinical trials?

The US Food and Drug Administration (FDA) approved aducanumab, an anti-amyloid immunotherapy, for the treatment of Alzheimer’s disease (AD) in 2021. The approval was based on the evidence that aducanumab reduces amyloid plaques in the brain. In this case, amyloid load was used as a surrogate endpoint, meaning that the reduction in amyloid plaques was thought to reflect clinical benefit, however is not itself a measure of clinical benefit. Nicolas Villain, MD, PhD, AP-HP Sorbonne University, Pitié-Salpêtrière Hospital, Paris, France, provides his perspective on this choice, particularly emphasizing that amyloid load in the brain is not directly related to cognitive symptoms, therefore it should not necessarily be used to predict clinical benefit. This interview took place at the Clinical Trials on Alzheimer’s Disease Congress 2022 in San Francisco.

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Independent of this work, NV received research support from Fondation Bettencourt-Schueller, Fondation Servier, Union Nationale pour les Intérêts de la Médecine (UNIM), Fondation Claude Pompidou, Fondation Alzheimer and Fondation pour la Recherche sur l’Alzheimer; travel grant from the Movement Disorders Society, Merz-Pharma, UCB Pharma, and GE Healthcare SAS; is an unpaid local principal investigator or sub-investigator in NCT04241068 and NCT05310071 (aducanumab, Biogen), NCT04437511 (donanemab, Eli-Lilly), NCT05463731 (remternetug, Eli-Lilly), NCT04592341 (gantenerumab, Roche), NCT03887455 (lecanemab, Eisai), NCT03352557 (gosuranemab, Biogen), NCT03828747 and NCT03289143 (semorinemab, Roche), NCT04619420 (JNJ-63733657, Janssen – Johnson & Johnson), NCT04374136 (AL001, Alector), NCT04592874 (AL002, Alector), NCT04867616 (bepranemab, UCB Pharma), NCT04777396 and NCT04777409 (semaglutide, Novo Nordisk), is an unpaid national coordinator for NCT05564169 (masitinib, ABScience); and has given unpaid lectures in symposia organized by Eisai and the Servier Foundation.