Can We Use Blood Biomarkers as Entry Criteria and for Monitoring Drug Treatment Effects in Clinical Trials? A Report from the EU/US CTAD Task Force

D. Angioni,O. Hansson, R. J. Bateman, C. Rabe, M. Toloue, J. B. Braunstein, S. Agus,J. R. Sims, T. Bittner, M. C. Carrillo, H. Fillit,C. L. Masters, S. Salloway, P. Aisen, M. Weiner,B. Vellas,S. Gauthier,Susan Abushakra, Mohammad Afshar, John Alam, Alicia Algeciras-Schimnich, Sandrine Andrieu, Clive Ballard, Amos Baruch,Richard Batrla, Monika Baudler, Joanne Bell, Sasha Bozeat, Dawn Brooks, Tricia Brooks,Szofia Bullain, Jan Burmeister,Min Cho,Emily Collins, Gavin Cook,Jeffrey Cummings, Chris Dague,Susan De Santi, Rachelle Doody, Billy Dunn,Michael Egan, Sven Eriksson,Rianne Esquivel, Tom Fagan, Phyllis Ferrell, Michela Gallagher, Anna-Kaija Grönblad, Avis Hains,Harald Hampel, Nanco Hefting, Suzanne Hendrix,Carole Ho, Helen Hu, Zahinoor Ismail, Daryl Jones, Gene Kinney, Paul Kinnon, Ricky Kurzman, Lars Lannfelt, John Lawson, Nathalie LeBastard, Valérie Legrand, Nicole Lewandowski, Carine Lim, Costantine Lyketsos, Donna Masterman, Ming Lu,Mark Mintun,José Luis Molinuevo, Cecilia Monteiro, Bradford Navia, Tomas Odergren, Gunilla Osswald,Lewis Penny,Michael Pontecorvo, Anton Porsteinsson, Rema Raman, Gesine Respondek,Larisa Reyderman, Sharon Rogers, Paul Rosenberg, Sharon Rosenzweig-Lipson, Mark Roskey,Rubel Carrie,Ziad Saad, Rachel Schindler, Dennis Selkoe, Melanie Shulman, Kaycee Sink, Lisa Sipe, Daniel Skovronsky, Elizabeth Somers, Maria Soto, Johannes Streffer,Pedro Such,Joyce Suhy, Jacques Touchon,Manu Vandijck, Anne White, David Wilson, Wagner Zago, Jin Zhou

The journal of prevention of Alzheimer's disease（2023）

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摘要

In randomized clinical trials (RCTs) for Alzheimer’s Disease (AD), cerebrospinal fluid (CSF) and positron emission tomography (PET) biomarkers are currently used for the detection and monitoring of AD pathological features. The use of less resource-intensive plasma biomarkers could decrease the burden to study volunteers and limit costs and time for study enrollment. Blood-based markers (BBMs) could thus play an important role in improving the design and the conduct of RCTs on AD. It remains to be determined if the data available on BBMs are strong enough to replace CSF and PET biomarkers as entry criteria and monitoring tools in RCTs.

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关键词

Alzheimer’s disease,randomized clinical trials,screening,monitoring,amyloid,tau

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