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O1‐09‐04: UPDATE ON THE SAFETY AND TOLERABILITY OF GANTENERUMAB IN THE ONGOING OPEN‐LABEL EXTENSION (OLE) OF THE MARGUERITE ROAD STUDY IN PATIENTS WITH MILD ALZHEIMER'S DISEASE (AD) AFTER APPROXIMATELY TWO YEARS OF STUDY DURATION
Author(s) -
Abi-Saab Danielle,
Andjelkovic Mirjana,
Pross Nathalie,
Delmar Paul,
Voyle Nicola,
Klein Gregory,
Esau Nelli,
Ristic Smiljana,
Martenyi Ferenc,
Fontoura Paulo,
Doody Rachelle
Publication year - 2018
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2018.06.2381
Subject(s) - tolerability , medicine , dosing , pharmacodynamics , adverse effect , surgery , pathology , pharmacokinetics
dosing, patients were analyzed in three groups: the MRDB placebo cohort (MR-Pbo), theMRDB cohort pretreated with gantenerumab (MR-Gant) and a SR DB cohort combining patients originally assigned to placebo or gantenerumab (SR). Change from baseline OLE in amyloid burden was assessed via global and regional standard uptake value ratio (SUVR) analysis of florbetapir PET at months 12 and 24. Results: Preliminary analysis of 40 patients (MR-Pbo, 14; MR-Gant, 17; SR, 9) showed mean (SD) 12-month changes in absolute SUVR units of -0.24 (0.21), -0.27 (0.14), and -0.13 (0.16) in the MR-Pbo, MR-Gant, and SR groups, respectively. Reductions in amyloid burden and percent of patients below the amyloid positivity threshold using an updated data cut (May 30, 2018) will be reported. Approximately 37 patients (MR-Pbo 12; MR-Gant 12; SR 13) will have their OLE 24 month PET scan for this analysis, not accounting for patient drop-out. Conclusions:Updated findings are expected to confirm preliminary results and show continued reduction in amyloid burden with ongoing treatment up to 24 months. This work supports our planned Phase 3 program using high doses of gantenerumab. 1. Klein, CTAD 2017.