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Investigational AD drugs solanezumab and gantenerumab fail to meet its primary endpoint in DIAN-TU Phase II/III study

Monday 10 February 2020

On 10 February, the Washington University School of Medicine announced top line results for its Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Phase II/III study. 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.

An initial analysis of the data from 194 participants showed that both investigational drugs missed the primary endpoint in the DIAN-TU Phase II/III study, which was a slowing cognitive decline as measured by multiple tests of thinking and memory. Additional analyses of secondary endpoints and biomarkers are ongoing. The company plans to present results at the Advances in Alzheimer's and Parkinson's Therapies (AAT-AD/PD™) Focus Meeting in Vienna in April. Whilst disappointing, the results will not change Roche’s plans for the continuation of its GRADUATE 1 and GRADUATE 2 Phase III trials evaluating gantenerumab in people with early AD. Solanezumab also continues to be studied in the A4 Phase III study.