US Food and Drug Administration Approval of Aducanumab—Is Amyloid Load a Valid Surrogate End Point for Alzheimer Disease Clinical Trials?-Reference-Cited by-同舟云学术

US Food and Drug Administration Approval of Aducanumab—Is Amyloid Load a Valid Surrogate End Point for Alzheimer Disease Clinical Trials?

Published:2021-11-01 Issue:11 Volume:78 Page:1307
ISSN:2168-6149
Container-title:JAMA Neurology
language:en
Short-container-title:JAMA Neurol

Author:

Planche Vincent¹²,Villain Nicolas³⁴

Affiliation:

1. University of Bordeaux, CNRS, IMN, UMR 5293, Bordeaux, France

2. Centre Mémoire Ressources Recherches, Pôle de Neurosciences Cliniques, CHU de Bordeaux, Bordeaux, France

3. AP-HP Sorbonne Université, Hôpital Pitié-Salpêtrière, Department of Neurology, Institute of Memory and Alzheimer’s Disease, Paris, France

4. Institut du Cerveau - ICM, Sorbonne Université, INSERM U1127, CNRS 7225, Paris, France

Publisher

American Medical Association (AMA)

Subject

Clinical Neurology

Link

https://jamanetwork.com/journals/jamaneurology/articlepdf/2784255/jamaneurology_planche_2021_vp_210013_1636576224.48116.pdf

Reference9 articles.

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2. Donanemab in early Alzheimer’s disease.;Mintun;N Engl J Med,2021

3. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aß protofibril antibody.;Swanson;Alzheimers Res Ther

4. Amyloid-ß 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials.;Liu;Neurology,2015

5. Long-term effects of Abeta42 immunisation in Alzheimer’s disease: follow-up of a randomised, placebo-controlled phase I trial.;Holmes;Lancet,2008

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