No benefit has been seen with two investigational drugs targeting amyloid beta in a major study aimed at preventing cognitive loss in the early stages of dominantly inherited Alzheimer’s disease.
Initial results from the Dominantly Inherited Alzheimer Network-Trials Unit (DIAN-TU) that evaluated solanezumab, made by Eli Lilly and gantenerumab, made by Roche/Genentech, showed that the treatment did not meet the primary cognitive endpoint.
After four years of treatment there was no effect on the primary outcome measure of slowing of cognitive decline in 52 patients with autosomal-dominant Alzheimer’s disease (ADAD) randomised to receive gantenerumab and 50 who received solanezumab compared to placebo.
Additional analyses of secondary endpoints – such as cerebral amyloid imaging and biomarkers are ongoing by Washington University
Both investigational drugs are designed to target and neutralise amyloid beta in the brain through different mechanisms and are being evaluated in other, more common forms of Alzheimer’s.
“Although the drugs we evaluated were not successful, the trial will move us forward in understanding Alzheimer’s,” said principal investigator Randall J. Bateman, MD, director of DIAN-TU and the Charles F. and Joanne Knight Distinguished Professor of Neurology at Washington University.
“The trial’s innovative design – developed in collaboration with a consortium of pharmaceutical companies, the National Institutes of Health (NIH), regulatory agencies and academic leaders – will make advances for future Alzheimer’s trials. Ongoing and continued research and trials will bring us closer to our goal to stop Alzheimer’s. We will continue until we are successful,” he said
The trial was conducted at 24 sites internationally including Australian sites such as Sydney (NeuRA), Melbourne and Perth.
A more detailed analysis of the trial’s data will be presented for the first time April 2 at the Advances in Alzheimer’s and Parkinson’s Therapies annual meeting in Vienna.
A third drug targeting amyloid beta – aducanumab –is under investigation for prevention of Alzheimer’s cognitive decline after being resurrected by Biogen last year following disappointing results in a Phase 3 trial.