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

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

doi:10.14283/jpad.2023.68

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

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 AfsharJohn 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

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Pages (from-to)	418-425
Number of pages	8
Journal	The journal of prevention of Alzheimer's disease
Volume	10
Issue number	3
DOIs	https://doi.org/10.14283/jpad.2023.68
State	Published - Sep 2023

Keywords

Alzheimer’s disease
amyloid
monitoring
randomized clinical trials
screening
tau

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10.14283/jpad.2023.68

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EU/US/CTAD Task Force, 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, S., ... Zhou, J. (2023). 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. The journal of prevention of Alzheimer's disease, 10(3), 418-425. https://doi.org/10.14283/jpad.2023.68

@article{6dddeba5ae03411884bdc9e7b37a21c7,

title = "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",

abstract = "In randomized clinical trials (RCTs) for Alzheimer{\textquoteright}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.",

keywords = "Alzheimer{\textquoteright}s disease, amyloid, monitoring, randomized clinical trials, screening, tau",

author = "{EU/US/CTAD Task Force} and D. Angioni and O. Hansson and Bateman, {R. J.} and C. Rabe and M. Toloue and Braunstein, {J. B.} and S. Agus and Sims, {J. R.} and T. Bittner and Carrillo, {M. C.} and H. Fillit and Masters, {C. L.} and S. Salloway and P. Aisen and M. Weiner and B. Vellas and S. Gauthier and Susan Abushakra and Mohammad Afshar and John Alam and Alicia Algeciras-Schimnich and Sandrine Andrieu and Clive Ballard and Amos Baruch and Richard Batrla and Monika Baudler and Joanne Bell and Sasha Bozeat and Dawn Brooks and Tricia Brooks and Szofia Bullain and Jan Burmeister and Min Cho and Emily Collins and Gavin Cook and Jeffrey Cummings and Chris Dague and {De Santi}, Susan and Rachelle Doody and Billy Dunn and Michael Egan and Sven Eriksson and Rianne Esquivel and Tom Fagan and Phyllis Ferrell and Michela Gallagher and Gr{\"o}nblad, {Anna Kaija} and Avis Hains and Harald Hampel and Nanco Hefting and Suzanne Hendrix and Carole Ho and Helen Hu and Zahinoor Ismail and Daryl Jones and Gene Kinney and Paul Kinnon and Ricky Kurzman and Lars Lannfelt and John Lawson and Nathalie LeBastard and Val{\'e}rie Legrand and Nicole Lewandowski and Carine Lim and Costantine Lyketsos and Donna Masterman and Ming Lu and Mark Mintun and Molinuevo, {Jos{\'e} Luis} and Cecilia Monteiro and Bradford Navia and Tomas Odergren and Gunilla Osswald and Lewis Penny and Michael Pontecorvo and Anton Porsteinsson and Rema Raman and Gesine Respondek and Larisa Reyderman and Sharon Rogers and Paul Rosenberg and Sharon Rosenzweig-Lipson and Mark Roskey and Rubel Carrie and Ziad Saad and Rachel Schindler and Dennis Selkoe and Melanie Shulman and Kaycee Sink and Lisa Sipe and Daniel Skovronsky and Elizabeth Somers and Maria Soto and Johannes Streffer and Pedro Such and Joyce Suhy and Jacques Touchon and Manu Vandijck and Anne White and David Wilson and Wagner Zago and Jin Zhou",

note = "Publisher Copyright: {\textcopyright} 2023, Serdi.",

year = "2023",

month = sep,

doi = "10.14283/jpad.2023.68",

language = "English",

volume = "10",

pages = "418--425",

journal = "The journal of prevention of Alzheimer's disease",

issn = "2274-5807",

number = "3",

}

EU/US/CTAD Task Force, Angioni, D, Hansson, O, Bateman, RJ, Rabe, C, Toloue, M, Braunstein, JB, Agus, S, Sims, JR, Bittner, T, Carrillo, MC, Fillit, H, Masters, CL, Salloway, S, Aisen, P, Weiner, M, Vellas, B, Gauthier, S, Abushakra, S, Afshar, M, Alam, J, Algeciras-Schimnich, A, Andrieu, S, Ballard, C, Baruch, A, Batrla, R, Baudler, M, Bell, J, Bozeat, S, Brooks, D, Brooks, T, Bullain, S, Burmeister, J, Cho, M, Collins, E, Cook, G, Cummings, J, Dague, C, De Santi, S, Doody, R, Dunn, B, Egan, M, Eriksson, S, Esquivel, R, Fagan, T, Ferrell, P, Gallagher, M, Grönblad, AK, Hains, A, Hampel, H, Hefting, N, Hendrix, S, Ho, C, Hu, H, Ismail, Z, Jones, D, Kinney, G, Kinnon, P, Kurzman, R, Lannfelt, L, Lawson, J, LeBastard, N, Legrand, V, Lewandowski, N, Lim, C, Lyketsos, C, Masterman, D, Lu, M, Mintun, M, Molinuevo, JL, Monteiro, C, Navia, B, Odergren, T, Osswald, G, Penny, L, Pontecorvo, M, Porsteinsson, A, Raman, R, Respondek, G, Reyderman, L, Rogers, S, Rosenberg, P, Rosenzweig-Lipson, S, Roskey, M, Carrie, R, Saad, Z, Schindler, R, Selkoe, D, Shulman, M, Sink, K, Sipe, L, Skovronsky, D, Somers, E, Soto, M, Streffer, J, Such, P, Suhy, J, Touchon, J, Vandijck, M, White, A, Wilson, D, Zago, W & Zhou, J 2023, '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', The journal of prevention of Alzheimer's disease, vol. 10, no. 3, pp. 418-425. https://doi.org/10.14283/jpad.2023.68

TY - JOUR

T1 - 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

AU - EU/US/CTAD Task Force

AU - Angioni, D.

AU - Hansson, O.

AU - Bateman, R. J.

AU - Rabe, C.

AU - Toloue, M.

AU - Braunstein, J. B.

AU - Agus, S.

AU - Sims, J. R.

AU - Bittner, T.

AU - Carrillo, M. C.

AU - Fillit, H.

AU - Masters, C. L.

AU - Salloway, S.

AU - Aisen, P.

AU - Weiner, M.

AU - Vellas, B.

AU - Gauthier, S.

AU - Abushakra, Susan

AU - Afshar, Mohammad

AU - Alam, John

AU - Algeciras-Schimnich, Alicia

AU - Andrieu, Sandrine

AU - Ballard, Clive

AU - Baruch, Amos

AU - Batrla, Richard

AU - Baudler, Monika

AU - Bell, Joanne

AU - Bozeat, Sasha

AU - Brooks, Dawn

AU - Brooks, Tricia

AU - Bullain, Szofia

AU - Burmeister, Jan

AU - Cho, Min

AU - Collins, Emily

AU - Cook, Gavin

AU - Cummings, Jeffrey

AU - Dague, Chris

AU - De Santi, Susan

AU - Doody, Rachelle

AU - Dunn, Billy

AU - Egan, Michael

AU - Eriksson, Sven

AU - Esquivel, Rianne

AU - Fagan, Tom

AU - Ferrell, Phyllis

AU - Gallagher, Michela

AU - Grönblad, Anna Kaija

AU - Hains, Avis

AU - Hampel, Harald

AU - Hefting, Nanco

AU - Hendrix, Suzanne

AU - Ho, Carole

AU - Hu, Helen

AU - Ismail, Zahinoor

AU - Jones, Daryl

AU - Kinney, Gene

AU - Kinnon, Paul

AU - Kurzman, Ricky

AU - Lannfelt, Lars

AU - Lawson, John

AU - LeBastard, Nathalie

AU - Legrand, Valérie

AU - Lewandowski, Nicole

AU - Lim, Carine

AU - Lyketsos, Costantine

AU - Masterman, Donna

AU - Lu, Ming

AU - Mintun, Mark

AU - Molinuevo, José Luis

AU - Monteiro, Cecilia

AU - Navia, Bradford

AU - Odergren, Tomas

AU - Osswald, Gunilla

AU - Penny, Lewis

AU - Pontecorvo, Michael

AU - Porsteinsson, Anton

AU - Raman, Rema

AU - Respondek, Gesine

AU - Reyderman, Larisa

AU - Rogers, Sharon

AU - Rosenberg, Paul

AU - Rosenzweig-Lipson, Sharon

AU - Roskey, Mark

AU - Carrie, Rubel

AU - Saad, Ziad

AU - Schindler, Rachel

AU - Selkoe, Dennis

AU - Shulman, Melanie

AU - Sink, Kaycee

AU - Sipe, Lisa

AU - Skovronsky, Daniel

AU - Somers, Elizabeth

AU - Soto, Maria

AU - Streffer, Johannes

AU - Such, Pedro

AU - Suhy, Joyce

AU - Touchon, Jacques

AU - Vandijck, Manu

AU - White, Anne

AU - Wilson, David

AU - Zago, Wagner

AU - Zhou, Jin

PY - 2023/9

Y1 - 2023/9

N2 - 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.

AB - 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.

KW - Alzheimer’s disease

KW - amyloid

KW - monitoring

KW - randomized clinical trials

KW - screening

KW - tau

UR - http://www.scopus.com/inward/record.url?scp=85162760530&partnerID=8YFLogxK

U2 - 10.14283/jpad.2023.68

DO - 10.14283/jpad.2023.68

M3 - Article

C2 - 37357282

AN - SCOPUS:85162760530

SN - 2274-5807

VL - 10

SP - 418

EP - 425

JO - The journal of prevention of Alzheimer's disease

JF - The journal of prevention of Alzheimer's disease

IS - 3

ER -

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

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Keywords

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