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

Author:

Høilund-Carlsen Poul F.12,Revheim Mona-Elisabeth34ORCID,Alavi Abass5,Satyamurthy Nagichettiar6,Barrio Jorge R.6

Affiliation:

1. Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark

2. Department of Clinical Research, University of Southern Denmark, Odense, Denmark

3. Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway

4. Institute of Clinical Medicine, University of Oslo, Oslo, Norway

5. Department of Radiology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA

6. Department of Molecular and Medical Pharmacology, David Geffen UCLA School of Medicine, Los Angeles, CA, USA

Abstract

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.

Publisher

IOS Press

Subject

Psychiatry and Mental health,Geriatrics and Gerontology,Clinical Psychology,General Medicine,General Neuroscience

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