Feb 10, 2020: Roche announced that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did not meet its primary endpoint in the people who have an early-onset, inherited form of the Alzheimer’s disease (AD), known as autosomal dominant AD (ADAD), accounts for less than 1% of all cases of the disease.
Gantenerumab’s safety profile in DIAN-TU-001 was reliable with that from other clinical trials of the investigational medicine and no new safety issues were recognized.
Roche is conducting additional analyses in order to understand the totality of the gantenerumab data from the study, in collaboration with the Washington University School of Medicine. Data will be presented at AAT-AD/PD Focus meeting in April 2020.
Gantenerumab, a latestage clinical drug, is still being tested in two major global Phase III trials (GRADUATE 1 and 2) in the wider population of people with AD not directly caused by gene mutations (sporadic AD).
Each individual with ADAD who received gantenerumab in DIAN-TU001 started on a lower dose and started titrating only about halfway through the trial at a five-fold higher target dose, prompted by lessons from other gantenerumab studies. The GRADUATE studies have been designed from the outset in order to maximise exposure to gantenerumab, bringing all the patients to target dose with minimal or no dose interruption within the study period.
Roche’s AD pipeline covers research medicines for different AD goals, forms, and phases. Roche tests semorinemab in phase II trials of intermittent AD, in addition to gantenerumab programme. Crenezumab also continues to be tested in ADAD’s Phase II trial of the
Alzheimer’s prevention program.
DIAN-TU-001 is a Phase II/III study sponsored by the Washington University School of Medicine in St. Louis, US. The study tested two investigational therapies compared to placebo (Roche’s gantenerumab and Eli Lilly’s solanezumab) just to determine if whichever of these treatments could slow the rate of cognitive decline and improve disease-related biomarkers in the people who are known to have a genetic mutation for inherited AD.
The study’s primary outcomes measures – The DIAN Multivariate Cognitive Endpoint is a novel outcome measure designed to assess cognitive performance in ADAD individuals.
