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Journal Articles Alzheimer's Research and Therapy Year : 2020

β-Secretase1 biological markers for Alzheimer’s disease: state-of-art of validation and qualification

Harald Hampel (1) , Simone Lista (1, 2, 3) , Eugeen Vanmechelen (4) , Henrik Zetterberg (5, 6, 7, 8) , Filippo Sean Giorgi (9) , Alessandro Galgani (9) , Kaj Blennow (8, 7) , Filippo Caraci (10, 11) , Brati Das , Riqiang Yan , Andrea Vergallo (1) , Mohammad Afshar , Lisi Flores Aguilar , Leyla Akman-Anderson , Joaquín Arenas , Jesús Ávila , Claudio Babiloni , Filippo Baldacci , Richard Batrla , Norbert Benda , Keith Black , Arun Bokde , Ubaldo Bonuccelli , Karl Broich , Francesco Cacciola , Filippo Caraci , Giuseppe Caruso , Juan Castrillo , Enrica Cavedo , Roberto Ceravolo , Patrizia Chiesa , Massimo Corbo , Jean-Christophe Corvol , Augusto Claudio Cuello , Jeffrey Cummings , Herman Depypere , Bruno Dubois , Andrea Duggento , Enzo Emanuele , Valentina Escott-Price , Howard Federoff , Maria Teresa Ferretti , Massimo Fiandaca , Richard Frank , Francesco Garaci , Hugo Geerts , Ezio Giacobini , Filippo Giorgi , Edward Goetzl , Manuela Graziani , Marion Haberkamp , Marie-Odile Habert (12) , Britta Hänisch , Harald Hampel , Karl Herholz , Felix Hernandez , Bruno Imbimbo , Dimitrios Kapogiannis , Eric Karran , Steven Kiddle , Seung 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 Neri , Robert Nisticò , Sid O’bryant , Giovanni Palermo , George Perry , Craig Ritchie , Simone Rossi , Amira Saidi , Emiliano Santarnecchi , Lon Schneider , Olaf Sporns , Nicola Toschi , Pedro Valenzuela , Bruno Vellas , Steven Verdooner , Andrea Vergallo , Nicolas Villain , Kelly Virecoulon Giudici , Mark Watling , Lindsay Welikovitch , Janet Woodcock , Erfan Younesi , José Zugaza
Brati Das
  • Function : Author
Riqiang Yan
  • Function : Author
Mohammad Afshar
  • Function : Author
Lisi Flores Aguilar
  • Function : Author
Leyla Akman-Anderson
  • Function : Author
Joaquín Arenas
  • Function : Author
Jesús Ávila
  • Function : Author
Claudio Babiloni
  • Function : Author
Filippo Baldacci
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Richard Batrla
  • Function : Author
Norbert Benda
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Keith Black
  • Function : Author
Arun Bokde
  • Function : Author
Ubaldo Bonuccelli
  • Function : Author
Karl Broich
  • Function : Author
Francesco Cacciola
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Filippo Caraci
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Giuseppe Caruso
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Juan Castrillo
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Enrica Cavedo
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Roberto Ceravolo
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Patrizia Chiesa
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Massimo Corbo
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Jean-Christophe Corvol
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Augusto Claudio Cuello
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Jeffrey Cummings
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Herman Depypere
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Bruno Dubois
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Andrea Duggento
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Enzo Emanuele
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Valentina Escott-Price
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Howard Federoff
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Maria Teresa Ferretti
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Massimo Fiandaca
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Richard Frank
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Francesco Garaci
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Hugo Geerts
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Ezio Giacobini
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Filippo Giorgi
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Edward Goetzl
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Manuela Graziani
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Marion Haberkamp
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Britta Hänisch
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Harald Hampel
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Karl Herholz
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Felix Hernandez
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Bruno Imbimbo
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Dimitrios Kapogiannis
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Eric Karran
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Steven Kiddle
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Seung Kim
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Yosef Koronyo
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Maya Koronyo-Hamaoui
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Todd Langevin
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Stéphane Lehéricy
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Pablo Lemercier
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Simone Lista
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Francisco Llavero
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Jean Lorenceau
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Alejandro Lucía
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Dalila Mango
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Mark Mapstone
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Christian Neri
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Robert Nisticò
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Sid O’bryant
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Giovanni Palermo
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George Perry
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Craig Ritchie
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Simone Rossi
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Amira Saidi
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Emiliano Santarnecchi
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Lon Schneider
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Olaf Sporns
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Nicola Toschi
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Pedro Valenzuela
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Bruno Vellas
Steven Verdooner
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Andrea Vergallo
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Nicolas Villain
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Kelly Virecoulon Giudici
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Mark Watling
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Lindsay Welikovitch
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Janet Woodcock
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Erfan Younesi
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José Zugaza
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Abstract

β-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.
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licence : CC BY - Attribution

Dates and versions

hal-03769540 , version 1 (02-04-2024)

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Harald Hampel, Simone Lista, Eugeen Vanmechelen, Henrik Zetterberg, Filippo Sean Giorgi, et al.. β-Secretase1 biological markers for Alzheimer’s disease: state-of-art of validation and qualification. Alzheimer's Research and Therapy, 2020, 12 (1), pp.130. ⟨10.1186/s13195-020-00686-3⟩. ⟨hal-03769540⟩
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