An investigational Alzheimer’s drug reduced molecular markers of disease and curbed neurodegeneration in the brain, without demonstrating evidence of cognitive benefit, in a phase 2/3 clinical trial led by researchers at Washington University School of Medicine in St. Louis through its Dominantly Inherited Alzheimer Network-Trials Unit (DIAN-TU). These results led the trial leaders to offer the drug, known as gantenerumab, to participants as part of an exploratory open-label extension. The researchers continue to monitor changes in measures of Alzheimer’s disease in those participants who are receiving the drug.
The DIAN-TU study (ClinicalTrials.gov Identifier: NCT01760005), published June 21 in Nature Medicine, evaluated the effects of two investigational drugs – gantenerumab, made by Roche and its U.S. affiliate, Genentech, and solanezumab, made by Eli Lilly and Co. – in people with a rare, inherited, early-onset form of Alzheimer’s known as dominantly inherited Alzheimer’s disease or autosomal dominant Alzheimer’s disease. Such people are born with a mutation that causes Alzheimer’s, and experience declines in memory and thinking skills starting as early as their 30s or 40s.
“Gantenerumab had a major impact on Alzheimer’s biomarkers,” 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 drug’s ability to shift multiple Alzheimer’s biomarkers toward normal indicates that it is positively affecting the disease process. The effect was strong enough that we launched an open-label extension of the trial so participants have the opportunity to stay on the drug as we continue to study it.”
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