On 21 June, researchers have published results from the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Phase II/III study in the journal Nature Medicine. It was announced last year that the study failed to meet its primary endpoint, which was a slowing cognitive decline as measured by multiple tests of thinking and memory.
The adaptive platform trial is a randomised, double-blind and placebo-controlled clinical trial assessing the safety, tolerability and efficacy of two drugs, solanezumab (made by Eli Lilly) and gantenerumab (made by Roche), in people at risk for and with a type of early-onset form of Alzheimer’s disease (AD) caused by a genetic mutation, called autosomal dominant AD. The trial, testing two investigational drugs to slow or prevent the progression of AD in autosomal dominant AD families, recruited participants in Australia, China, Europe and US. 52 participants were assigned to receive gantenerumab, 52 solanezumab and 40 placebo. They were followed for up to seven years.
In the published study, analyses of secondary endpoints and biomarkers are reported. Participants who received gantenerumab showed a significant reduction of amyloid plaques and tau protein in the brain, compared to placebo. The solanezumab-treated group showed a greater cognitive decline on some measures and did not show benefits on biomarkers. Following the biomarkers results, researchers will conduct an open-label extension study of gantenerumab, to continue to monitor the effect on gantenerumab over time.
