Basel: Roche, recently announced that the gantenerumab arm of 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.
"We are very grateful to all those involved in this study and hope the data can further contribute to the science and collective understanding of this complex disease," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "Although DIAN-TU didn't reach its primary endpoint, the trial represents the first of its kind and a bold undertaking by all partners involved. Given its experimental nature, we are unable to draw firm conclusions about the impact of gantenerumab in autosomal-dominant Alzheimer's disease. This outcome does not reduce our confidence in the ongoing Phase III GRADUATE clinical programme."
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 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.
Roche's AD pipeline spans investigational medicines for different targets, types and stages of AD. In addition to the gantenerumab programme, Roche is evaluating semorinemab in Phase II studies in sporadic AD. Crenezumab also continues to be studied in the Alzheimer's Prevention Initiative Phase II trial in ADAD.
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