Dados do Trabalho

Título

Using an external control to contextualize efficacy data from patients with prodromal and mild Alzheimer’s disease treated with gantenerumab in SCarlet RoAD and Marguerite RoAD open-label extension studies

Resumo

Gantenerumab, a human monoclonal antibody targeting aggregated beta-amyloid (Abeta), is a potential disease-modifying treatment for early (prodromal-to-mild) Alzheimer’s disease (AD). SCarlet RoAD (SR) (NCT01224106) and Marguerite RoAD (MR) (NCT02051608) were two Phase III trials with open-label extensions (OLEs), during which participants were treated with up to 1,200 mg/month of subcutaneous gantenerumab for up to 5 years. This work aims to evaluate the gantenerumab treatment effect during the SR and MR uncontrolled OLE studies by using an external control group based on the Alzheimer’s Disease Neuroimaging Initiative (ADNI) cohort.
Participants from the ADNI studies were weighted using the inverse probability of treatment weighting method to make their demographics and baseline characteristics more comparable to the patients in the OLE stages of the pooled SR and MR studies. In the weighted sample, the treatment effects of gantenerumab, per change from the OLE Baseline in CDR-SB, ADAS-Cog13, MMSE at Weeks 104 and 156 were investigated by a mixed-effect model of repeated measure.
Participants (N = 164) from the SR and MR OLE studies and 1,218 participants from ADNI were selected. After weighting, the demographics and baseline characteristics were comparable between the two populations. Relative reductions between the pooled participants in SR and MR OLE studies and weighted ADNI participants were found for CDR-SB and ADAS-Cog13 at weeks 104 and 156, with greater reductions in SR and MR participants. Conclusion: When comparing participants in the SR and MR OLE studies to a matched ADNI control group, a slower progression was observed with gantenerumab treatment.

Palavras Chave

Clínicas trials, Alzheimer’s disease