Roche Pharmaceutical Development and Sales Overview
Gantenerumab (RG1450)
Fully human monoclonal antibody binding aggregated forms of AB
Indication
Prodromal Alzheimer's disease
Mild Alzheimer's disease
Roche
Cognitively unimpaired participants at risk for or
at the earliest stages of Alzheimer's disease
Phase/study
# of patients
Design
"
Primary endpoint
Status
Phase II/III
Scarlet ROAD¹
N=799
104-week SC treatment period:
ARM A: Gantenerumab (225 mg)
ARM B: Gantenerumab (105 mg)
ARM C: Placebo
Change in CDR-SOB at 2 years
Sub-study: change in brain amyloid by
PET at 2 years
Phase I PET data: Archives of Neurology,
2012 Feb;69(2):198-207
Recruitment completed Q4 2013
Dosing stopped due to futility Q4 2014
FPI in open label extension study Q4 2015
Published in Alzheimers Res Ther 2017
Dec 8;9(1):95
Phase III
Marguerite ROAD¹
N=389
104-week SC treatment period:
ARM A: Gantenerumab
ARM B: Placebo
Change in ADAS-Cog and CDR-SOB at 2 years
(co-primary)
Phase III
SKYLINE²
N=1,200
ARM A: Gantenerumab q1w or q2w (patient
preference)
ARM B: Placebo
Cognitive composite (PACC5)
•
FPI Q1 2014
FPI Q2 2022
Recruitment stopped Q4 2015
"
FPI Q1 2016 for open label extension
CT Identifier
NCT01224106
36 OLE data published in J Prev Alzheimers Dis 2021;8(1):3-6
NCT02051608
NCT05256134
'In collaboration with MorphoSys AG; 2In collaboration with Banner Alzheimer's Institute
AB-amyloid-beta; CDR-SOB-Clinical Dementia Rating Scale Sum of Boxes; PET= positron emission tomography; ADAS-cog-Alzheimer's Disease Assessment Scale cognitive subscale; SC=Subcutaneous; OLE=Open Label
Extension; PACC5=Preclinical Alzheimer's Cognitive Composite
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