학술논문
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
Document Type
Original Paper
Author
Angioni, D.; Hansson, O.; Bateman, R. J.; Rabe, C.; Toloue, M.; Braunstein, J. B.; Agus, S.; Sims, J. R.; Bittner, T.; Carrillo, M. C.; Fillit, H.; Masters, C. L.; Salloway, S.; Aisen, P.; Weiner, M.; Vellas, B.; Gauthier, S.; Abushakra, Susan; Afshar, Mohammad; Alam, John; Algeciras-Schimnich, Alicia; Andrieu, Sandrine; Ballard, Clive; Baruch, Amos; Batrla, Richard; Baudler, Monika; Bell, Joanne; Bozeat, Sasha; Brooks, Dawn; Brooks, Tricia; Bullain, Szofia; Burmeister, Jan; Cho, Min; Collins, Emily; Cook, Gavin; Cummings, Jeffrey; Dague, Chris; De Santi, Susan; Doody, Rachelle; Dunn, Billy; Egan, Michael; Eriksson, Sven; Esquivel, Rianne; Fagan, Tom; Ferrell, Phyllis; Gallagher, Michela; Grönblad, Anna-Kaija; Hains, Avis; Hampel, Harald; Hefting, Nanco; Hendrix, Suzanne; Ho, Carole; Hu, Helen; Ismail, Zahinoor; Jones, Daryl; Kinney, Gene; Kinnon, Paul; Kurzman, Ricky; Lannfelt, Lars; Lawson, John; LeBastard, Nathalie; Legrand, Valérie; Lewandowski, Nicole; Lim, Carine; Lyketsos, Costantine; Masterman, Donna; Lu, Ming; Mintun, Mark; Molinuevo, José Luis; Monteiro, Cecilia; Navia, Bradford; Odergren, Tomas; Osswald, Gunilla; Penny, Lewis; Pontecorvo, Michael; Porsteinsson, Anton; Raman, Rema; Respondek, Gesine; Reyderman, Larisa; Rogers, Sharon; Rosenberg, Paul; Rosenzweig-Lipson, Sharon; Roskey, Mark; Carrie, Rubel; Saad, Ziad; Schindler, Rachel; Selkoe, Dennis; Shulman, Melanie; Sink, Kaycee; Sipe, Lisa; Skovronsky, Daniel; Somers, Elizabeth; Soto, Maria; Streffer, Johannes; Such, Pedro; Suhy, Joyce; Touchon, Jacques; Vandijck, Manu; White, Anne; Wilson, David; Zago, Wagner; Zhou, Jin
Source
The Journal of Prevention of Alzheimer's Disease. 10(3):418-425
Subject
Language
English
ISSN
2426-0266
Abstract
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.