Feb 10, 2020: Eli Lilly and Company announced that the analysis performed by the Washington University School of Medicine in the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study showed that the solanezumab did not meet the primary endpoint. Additional analyses of secondary endpoints and biomarkers are ongoing by the Washington University and Lilly.
Data will be presented at the Advances in Alzheimer’s and Parkinson’s Therapies (AAT-AD/PD™) Focus Meeting in April of 2020. At this time, Lilly does not plan to chase a submission for solanezumab in people with dominantly inherited Alzheimer’s disease (DIAD), also known as autosomal dominant Alzheimer’s disease, based on results of the primary endpoint. This outcome does not force the ongoing solanezumab Anti-Amyloid Treatment in the Asymptomatic Alzheimer’s (A4) Study.
The experiment on the DIAN-TU platform is a randomized, double-blind, placebo-controlled, Phase 2/3 test. The goal is to study possible disease-modifying treatments in individuals at risk for or with Alzheimer’s disease dominantly inherited, which is caused by unusual gene mutations. This started as a two-year study of biomarker goal involvement and progressed into a Phase 2/3 analysis of registration with a primary measure of cognitive performance and a total of four years of treatment. The primary efficiency analysis included 50 solanezumab and 40 placebo participants. The minimum four-year treatment period was finished by 36 solanezumab and 32 placebo participants. The initial dose for the study was 400 mg every 4 weeks. A late change to the analysis raised the dose, which resulted in approximately 25% of the total doses being administered at 1600 mg.
The DIAN-TU Study was established in 2010 and funded by Lilly, Roche and Genentech, National Institutes of Health, and other donors and is the first disease prevention trial in order to test investigational Alzheimer’s disease compounds with different mechanisms of action from two pharmaceutical companies.
Solanezumab is an investigational anti-amyloid monoclonal antibody tested in the Asymptomatic Alzheimer’s (A4) analysis of preclinical Alzheimer’s disease in Anti-Amyloid Therapy. The A4 Study is a clinical trial that studies solanezumab in older people who have signs of amyloid in their brains, but do not show memory loss symptoms.
The DIAN-Multivariate Cognitive Endpoint (DIAN MCE) is composed of Wechsler Memory ScaleRevised Logical Memory Delayed Recall, Cogstate International Shopping List Test, Wechsler Adult Intelligence ScaleRevised Digit Symbol Substitution Test, and Mini-Mental State Analysis.https://investor.lilly.com/news-releases/news-release-details/lilly-announces-topline-results-solanezumab-dominantly-inherited
