AAT-ADPD, 15-18 March 2018, Torino
Welcome to Roche at AAT-ADPD 2018
AAT-ADPD is a new joint meeting between the International Geneva/Springfield Symposium on Advances in Alzheimer Therapy (AAT) and AD/PDTM. Healthcare professionals could learn about all the latest breakthroughs in Alzheimer’s and Parkinson’s including treatment, translational R&D, drug development and clinical trials.
AAT-ADPD 2018 – March 15-18, Torino
Discover Roche’s information from this year’s AAT-ADPD on this page, including posters and an oral presentation.
Latest on Medically from AAT-ADPD 2018
AAT-ADPD 2018 poster- Safety and tolerability and pharmacokinetics of crenezumab in mild-to-moderate AD patients treated with escalating doses for up to 32 months
The ongoing Phase 1b study GN29632 was designed to provide information on the safety, tolerability and pharmacokinetics of crenezumab delivered at higher doses than used in the Phase 2 ABBY and BLAZE studies, and to support the Phase 3 studies. The study enrolled patients with probable mild-to moderate AD per NINCDS-ADRDA criteria. Updated safety data for patients who have received crenezumab for up to 32 months, and pooled PK and PD data from this study plus ABBY and BLAZE are presented. Safety analyses showed that the majority of AEs were low grade and non-serious with no protocol-defined dose-limiting toxicities or drug-related SAEs (as assessed by the investigator). Crenezumab PK was dose-proportional between 15 to 120 mg/kg and PK/PD analyses demonstrated peripheral target engagement. The low number of ARIA events support the hypothesis that the IgG4 backbone and binding profile of crenezumab reduces the risk for ARIA.
AAT-ADPD 2018 oral presentation- The effect of speed of injection on pain, tolerability, safety, and pharmacokinetics following SC administration of gantenerumab
Gantenerumab is being evaluated for the treatment of prodromal to mild-stage Alzheimer’s Disease. The primary objective of this study was to investigate injection site pain associated with a 2-mL injection of gantenerumab administered subcutaneously (SC) in the abdomen over 5 and 15 seconds. In this randomized, open-label, two-cohort investigation study with cross-over design within each cohort, 48 healthy participants received one SC dose of 300 mg gantenerumab (2 mL) in one lower quadrant of the abdomen over 5 or 15 seconds, followed by SC administrations of placebo solution at the same respective injection speed. Pain at the injection site was assessed immediately after dosing using a 100-mm visual analogue scale (VAS).
AAT-ADPD 2018 oral presentation- Analysis of factors and methodologic considerations affecting plaque reduction measures via PET in the gantenerumab open-label extension studies
Gantenerumab is a fully human monoclonal antibody currently under evaluation at titrated doses up to 1200 mg sc monthly in the Scarlet RoAD (SR, NCT01224106) and Marguerite RoAD (MR, NCT02051608) open label extension (OLE) studies. High levels of florbetapir PET amyloid reduction in Alzheimer’s patients has been observed with gantenerumab treatment, measured by standard uptake value ratio (SUVR) methods using a cerebellar grey reference region. Here we report amyloid burden using alternative SUVR methods (template-space and native-space Freesurfer), and relate amyloid reductions to factors including baseline SUVR and dosing schedules.
AAT-ADPD 2018 oral presentation- Optimizing the gantenerumab phase III dosing regimen through PK-PD modeling and clinical trial simulations
The key objective of this work was to determine a safe, potentially efficacious and simple dosing regimen for both ApoEε4 carriers and non-carriers. Mathematical PK-PD models for PET (surrogate for efficacy) and ARIA (safety) were developed to establish an optimal gantenerumab dosing regimen. Several titration regimens were tested in open-label-extension from previous phase 3 studies to evaluate the safety and plaque removal of higher doses of gantenerumab. Combining retrospective internal and external data as well as new data from the open label studies, updated PK-PD models were used to simulate different titration regimens. The holistic approach of combining available internal and external data through PK/PD modeling and prospectively generated clinical data to confirm the model assumption allowed the team to develop an optimized dosing regimen to be used in the new gantenerumab phase 3 program.
AAT-ADPD 2018 booth touchscreen content
This file contains the content displayed on the touchscreens at the AAT-ADPD 2018 congress booth. Four topics are covered: current clinical trials in Alzheimer's disease, AD diagnostics (including the Elecsys platform), current Roche research in Parkinson's disease, and an overview of the Roche neuroscience pipeline. All content in the PPT file is hyperlinked for ease of navigation - please view the file in show mode to use the hyperlinks.