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Clinical Trial
. 2021;8(1):3-6.
doi: 10.14283/jpad.2020.68.

Thirty-Six-Month Amyloid Positron Emission Tomography Results Show Continued Reduction in Amyloid Burden with Subcutaneous Gantenerumab

G Klein  1 , P Delmar, G A Kerchner, C Hofmann, D Abi-Saab, A Davis, N Voyle, M Baudler, P Fontoura, R Doody
Affiliations
Clinical Trial

Thirty-Six-Month Amyloid Positron Emission Tomography Results Show Continued Reduction in Amyloid Burden with Subcutaneous Gantenerumab

G Klein et al. J Prev Alzheimers Dis. 2021.

Abstract

Previous findings from the positron emission tomography (PET) substudy of the SCarlet RoAD and Marguerite RoAD open-label extension (OLE) showed gantenerumab doses up to 1200 mg every 4 weeks administered subcutaneously resulted in robust beta-amyloid (Aβ) plaque removal over 24 months in people with prodromal-to-moderate Alzheimer's disease (AD). In this 36-month update, we demonstrate continued reduction, with mean (standard error) centiloid values at 36 months of -4.3 (7.5), 0.8 (6.7), and 4.7 (8.0) in the SCarlet RoAD (double-blind pooled placebo and active groups), Marguerite RoAD double-blind placebo, and Marguerite RoAD double-blind active groups respectively, representing a change of -57.0 (10.3), -90.3 (9.0), and -74.9 (10.5) centiloids respectively. These results demonstrate that prolonged gantenerumab treatment, at doses up to 1200 mg, reduces amyloid plaque levels below the amyloid positivity threshold. The ongoing GRADUATE Phase III trials will evaluate potential clinical benefits associated with gantenerumab-induced amyloid-lowering in people with early (prodromal-to-mild) AD.

Keywords: Alzheimer’s disease; Gantenerumab; amyloid; positron emission tomography.

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Conflict of interest statement

GK, PD, GAK, CH, DA-S and PF were full-time employees of F. Hoffmann-La Roche Ltd during the conduct of the study. GK, PD, GAK, CH, DA-S, NV and PF are shareholders in F. Hoffmann-La Roche Ltd. AD and NV were full-time employees of Roche Products Ltd during the conduct of the study. AD is currently employed at the MRC Clinical Trials Unit at UCL. MB and RD are full-time employees and shareholders in F. Hoffmann-La Roche Ltd and Genentech Inc. CH has an Alzheimer’s disease-related patent planned which is relevant to this study.

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