Gantenerumab arm of the phase II/III DIAN-TU-001 study did not meet its primary endpoint for early- onset Alzheimer's disease.- Roche

Roche has announced that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did not meet its primary endpoint in people who have an early-onset, inherited form of Alzheimer’s disease (AD). This form of AD, known as autosomal dominant AD (ADAD), accounts for less than 1% of all cases of the disease. The study, sponsored by Washington University School of Medicine in St. Louis, US, did not show a significant slowing of the rate of cognitive decline in people treated with investigational medicine gantenerumab as measured by the novel DIAN Multivariate Cognitive Endpoint, compared with placebo. Overall, gantenerumab's safety profile in DIAN-TU-001 was consistent with that from other clinical trials of the investigational medicine and no new safety issues were identified. Roche is conducting additional analyses to understand the totality of the gantenerumab data from the study, in collaboration with Washington University School of Medicine. Data will be presented at the AAT-AD/PD Focus meeting in April 2020. Comment: Gantenerumab, a late-stage investigational medicine, continues to be studied in two large global Phase III studies (GRADUATE 1 and 2) in the broader population of people with AD that is not directly caused by gene mutations (sporadic AD). Every person with ADAD (autosomal dominant AD) who received gantenerumab in DIAN-TU-001 started on a lower dose and only started titrating to a fivefold higher target dose approximately halfway through the trial, prompted by learnings from other studies of gantenerumab. The GRADUATE studies have been designed from the outset to maximise exposure to gantenerumab, bringing all patients to target dose with minimal or no dose interruption within the study period.