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Get Free Accessβ-Secretase1 (BACE1) protein concentrations and rates of enzyme activity, analyzed in human bodily fluids, are promising candidate biological markers for guidance in clinical trials investigating BACE1 inhibitors to halt or delay the dysregulation of the amyloid-β pathway in Alzheimer's disease (AD). A robust body of evidence demonstrates an association between cerebrospinal fluid/blood BACE1 biomarkers and core pathophysiological mechanisms of AD, such as brain protein misfolding and aggregration, neurodegeneration, and synaptic dysfunction.In pharmacological trials, BACE1 candidate biomarkers may be applied to a wide set of contexts of use (CoU), including proof of mechanism, dose-finding, response and toxicity dose estimation. For clinical CoU, BACE1 biomarkers show good performance for prognosis and disease prediction.The roadmap toward validation and qualification of BACE1 biomarkers requires standardized pre-analytical and analytical protocols to reduce inter-site variance that may have contributed to inconsistent results.BACE1 biomarker-drug co-development programs, including biomarker-guided outcomes and endpoints, may support the identification of sub-populations with a higher probability to benefit from BACE1 inhibitors with a reduced risk of adverse effects, in line with the evolving precision medicine paradigm.
Harald Hampel, Simone Lista, Eugeen Vanmechelen, Henrik Zetterberg, Filippo Sean Giorgi, Alessandro Galgani, Kaj Blennow, Filippo Caraci, Brati Das, Riqiang Yan, Andrea Vergallo, Mohammad Afshar, Lisi Flores Aguilar, Leyla Akman-Anderson, Joaquı́n Arenas, Jesús Ávila, Claudio Babiloni, Filippo Baldacci, Richard Batrla, Norbert Benda, Keith L. Black, Arun L.W. Bokde, Ubaldo Bonuccelli, Karl Broich, Francesco Cacciola, Giuseppe Caruso, Juan Carlos Martínez‐Castrillo, Enrica Cavedo, Roberto Ceravolo, Patrizia A. Chiesa, Massimo Corbo, Jean‐Christophe Corvol, A. Claudio Cuello, Jeffrey L. Cummings, Herman Depypere, Bruno Dubois, Andrea Duggento, Enzo Emanuele, Valentina Escott‐Price, Howard J. Federoff, Maria Teresa Ferretti, Massimo S. Fiandaca, Richard Frank, Francesco Garaci, Hugo Geerts, Ezio Giacobini, Filippo Sean Giorgi, Edward J. Goetzl, Manuela Graziani, Marion Haberkamp, Marie‐Odile Habert, Britta Hänisch, Karl Herholz, Félix Hernández, Bruno P. Imbimbo, Dimitrios Kapogiannis, Eric Karran, Steven J. Kiddle, Seung Hyun Kim, Yosef Koronyo, Maya Koronyo‐Hamaoui, Todd Langevin, Stéphane Lehéricy, Pablo Lemercier, Simone Lista, Francisco Llavero, Jean Lorenceau, Alejandro Lucía, Dalila Mango, Mark Mapstone, Christian Néri, Robert Nisticò, Sid E. O’Bryant, Giovanni Palermo, George Perry, Craig Ritchie, Símone Rossi, Amira Saidi, Emiliano Santarnecchi, Lon S. Schneider, Olaf Sporns, Nicola Toschi, Pedro L. Valenzuela, Bruno Vellas, Steven R. Verdooner, Andrea Vergallo, Nicolas Villain, Kelly Virecoulon Giudici, Mark Watling, Lindsay A. Welikovitch, Janet Woodcock, Erfan Younesi, José L. Zugaza (2020). β-Secretase1 biological markers for Alzheimer’s disease: state-of-art of validation and qualification. , 12(1), DOI: https://doi.org/10.1186/s13195-020-00686-3.
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Type
Article
Year
2020
Authors
93
Datasets
0
Total Files
0
Language
en
DOI
https://doi.org/10.1186/s13195-020-00686-3
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