β-Secretase1 biological markers for Alzheimer’s disease: state-of-art of validation and qualification
- Hampel H.
- Lista S.
- Vanmechelen E.
- Zetterberg H.
- Giorgi F. S.
- Galgani A.
- Blennow K.
- Caraci F.
- Das B.
- Yan R.
- Vergallo A.
- Aguilar L. F.
- Akman-Anderson L.
- Arenas J.
- Avila J.
- Babiloni C.
- Baldacci F.
- Batrla R.
- Benda N.
- Black K. L.
- Bokde A. L. W.
- Bonuccelli U.
- Broich K.
- Cacciola F.
- Caruso G.
- Castrillo J.
- Cavedo E.
- Ceravolo R.
- Chiesa P. A.
- Corbo M.
- Corvol J. -C.
- Cuello A. C.
- Cummings J. L.
- Depypere H.
- Dubois B.
- Duggento A.
- Emanuele E.
- Escott-Price V.
- Federoff H.
- Ferretti M. T.
- Fiandaca M.
- Frank R. A.
- Garaci F.
- Geerts H.
- Giacobini E.
- Giorgi F. S.
- Goetzl E. J.
- Graziani M.
- Haberkamp M.
- Habert M. -O.
- Hanisch B.
- Herholz K.
- Hernandez F.
- Imbimbo B. P.
- Kapogiannis D.
- Karran E.
- Kiddle S. J.
- Kim S. H.
- Koronyo Y.
- Koronyo-Hamaoui M.
- Langevin T.
- Lehericy S.
- Lemercier P.
- Llavero F.
- Lorenceau J.
- Lucia A.
- Mango D.
- Mapstone M.
- Neri C.
- Nistico R.
- O'Bryant S. E.
- Palermo G.
- Perry G.
- Ritchie C.
- Rossi S.
- Saidi A.
- Santarnecchi E.
- Schneider L. S.
- Sporns O.
- Toschi N.
- Valenzuela P. L.
- Vellas B.
- Verdooner S. R.
- Vergallo A.
- Villain N.
- Virecoulon Giudici K.
- Watling M.
- Welikovitch L. A.
- Woodcock J.
- Younesi E.
- Zugaza J. L.
DOIAbstract
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 ...
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