Results from the two Phase 3 trials of Gantenerumab in early AD have been published

16/11/2023

In November 2022, the pharmaceutical company Roche announced that its Phase III GRADUATE I and II studies of gantenerumab, an investigational anti-amyloid beta antibody, for the treatment of early Alzheimer’s disease (AD), did not meet their primary endpoint. The GRADUATE studies were two global, double-blind, randomised and placebo-controlled clinical trials evaluating gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer’s and mild Alzheimer’s dementia, collectively called early AD. In these two identically designed studies, 1,965 participants across 30 countries received either gantenerumab or placebo by subcutaneous injection every two weeks. The primary outcome was the change from baseline in the score on the Clinical Dementia Rating scale–Sum of Boxes at week 116. The findings have been recently published in The New England Journal of Medicine. Authors concluded that among people with early AD, the use of gantenerumab led to a lower amyloid plaque burden than placebo at 116 weeks but was not associated with slower clinical decline. https://www.nejm.org/doi/full/10.1056/NEJMoa2304430