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Amyloid PET: A Questionable Single Primary Surrogate Efficacy Measure on Alzheimer Immunotherapy Trials

Using amyloid PET imaging as a single primary surrogate efficacy measure in Alzheimer’s disease immunotherapy trials, as happened when the FDA granted accelerated approval of aducanumab, is unjustified. In vivo evidence indicates that PET quantification of amyloid deposition is distorted and misrepr...

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Autores principales: Høilund-Carlsen, Poul F., Revheim, Mona-Elisabeth, Alavi, Abass, Satyamurthy, Nagichettiar, Barrio, Jorge R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: IOS Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9789473/
https://www.ncbi.nlm.nih.gov/pubmed/36278356
http://dx.doi.org/10.3233/JAD-220841
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author Høilund-Carlsen, Poul F.
Revheim, Mona-Elisabeth
Alavi, Abass
Satyamurthy, Nagichettiar
Barrio, Jorge R.
author_facet Høilund-Carlsen, Poul F.
Revheim, Mona-Elisabeth
Alavi, Abass
Satyamurthy, Nagichettiar
Barrio, Jorge R.
author_sort Høilund-Carlsen, Poul F.
collection PubMed
description Using amyloid PET imaging as a single primary surrogate efficacy measure in Alzheimer’s disease immunotherapy trials, as happened when the FDA granted accelerated approval of aducanumab, is unjustified. In vivo evidence indicates that PET quantification of amyloid deposition is distorted and misrepresents effects of anti-amyloid treatments due to lack of specificity of the PET imaging probe, effects of amyloid-related imaging abnormalities, spill-over from high white matter signals, and questionable quantification models. Before granting approval to other immunotherapy candidates, the FDA should require rigorous evidence of all imaging claims and irrefutable documentation that proposed treatments are clinically effective and harmless to patients.
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spelling pubmed-97894732023-01-17 Amyloid PET: A Questionable Single Primary Surrogate Efficacy Measure on Alzheimer Immunotherapy Trials Høilund-Carlsen, Poul F. Revheim, Mona-Elisabeth Alavi, Abass Satyamurthy, Nagichettiar Barrio, Jorge R. J Alzheimers Dis Commentary Using amyloid PET imaging as a single primary surrogate efficacy measure in Alzheimer’s disease immunotherapy trials, as happened when the FDA granted accelerated approval of aducanumab, is unjustified. In vivo evidence indicates that PET quantification of amyloid deposition is distorted and misrepresents effects of anti-amyloid treatments due to lack of specificity of the PET imaging probe, effects of amyloid-related imaging abnormalities, spill-over from high white matter signals, and questionable quantification models. Before granting approval to other immunotherapy candidates, the FDA should require rigorous evidence of all imaging claims and irrefutable documentation that proposed treatments are clinically effective and harmless to patients. IOS Press 2022-12-06 /pmc/articles/PMC9789473/ /pubmed/36278356 http://dx.doi.org/10.3233/JAD-220841 Text en © 2022 – The authors. Published by IOS Press https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial (CC BY-NC 4.0) License (https://creativecommons.org/licenses/by-nc/4.0/) , which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Commentary
Høilund-Carlsen, Poul F.
Revheim, Mona-Elisabeth
Alavi, Abass
Satyamurthy, Nagichettiar
Barrio, Jorge R.
Amyloid PET: A Questionable Single Primary Surrogate Efficacy Measure on Alzheimer Immunotherapy Trials
title Amyloid PET: A Questionable Single Primary Surrogate Efficacy Measure on Alzheimer Immunotherapy Trials
title_full Amyloid PET: A Questionable Single Primary Surrogate Efficacy Measure on Alzheimer Immunotherapy Trials
title_fullStr Amyloid PET: A Questionable Single Primary Surrogate Efficacy Measure on Alzheimer Immunotherapy Trials
title_full_unstemmed Amyloid PET: A Questionable Single Primary Surrogate Efficacy Measure on Alzheimer Immunotherapy Trials
title_short Amyloid PET: A Questionable Single Primary Surrogate Efficacy Measure on Alzheimer Immunotherapy Trials
title_sort amyloid pet: a questionable single primary surrogate efficacy measure on alzheimer immunotherapy trials
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9789473/
https://www.ncbi.nlm.nih.gov/pubmed/36278356
http://dx.doi.org/10.3233/JAD-220841
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