Molecular markers of Alzheimer's disease and resulting neurodegeneration in the brain were curbed down by an investigational drug for the disease, 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), published in the journal Nature Medicine. Alzheimer's disease (AD) is a neurodegenerative disease that leads to gradual memory loss and behavioral changes. It is characterized by the formation of beta-amyloid plaques and neurofibrillary tangles in the brain tissues, almost 20 years before the actual symptoms occur. This further leads to the shrinkage of the brain tissue.
‘An investigational Alzheimer's drug reduced molecular markers of disease and curbed neurodegeneration in the brain, without demonstrating evidence of cognitive benefit, in a clinical trial. This might thereby help in formulating the prevention or treatment of Alzheimer's diseases.’
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"Gantenerumab had a major impact on Alzheimer's biomarkers. 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," says principal investigator Randall J. Bateman, MD, director of DIAN-TU and the Charles F. and Joanne Knight Distinguished Professor of Neurology at Washington University. Role of Investigational drug in Alzheimer's disease
The team thereby analyzed the gradually escalated dosage effects of two investigational drugs – gantenerumab and solanezumab in 144 participants with a rare, inherited, early-onset form of Alzheimer's known as dominantly inherited Alzheimer's disease or autosomal dominant Alzheimer's disease in an exploratory open-label extension study. They were followed up for seven years (average of five years). Among them, 52 patients were randomized to gantenerumab and simultaneously were monitored for the changes in the measures of the disease.
It was found that neither of the drug had shown prevention or slowing of cognitive decline in people who are nearly certain to develop Alzheimer's due to genetic mutations and in participants who had no symptoms. There were no new safety issues for the drug being identified.
However, the effect of the drugs on molecular and cellular signs of Alzheimer's disease – the secondary endpoint of the study exhibited potential benefit.
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The study might thereby help in the prevention or treatment of Alzheimer's diseases by hampering the destructive molecular and cellular processes in the brain.
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