Novo Nordisk A/S: Evoke phase 3 trials did not demonstrate a statistically significant reduction in Alzheimer's disease progression
- Co announced the top-line results from the 2-year primary analysis of evoke and evoke+ phase 3 trials in early-stage symptomatic Alzheimer's disease. The two trials were randomised, double-blinded, enrolled a total of 3808 adults and evaluated the efficacy and safety of oral semaglutide compared to placebo on top of standard of care. The decision to pursue an Alzheimer's disease indication with semaglutide was based on real-world evidence studies, pre-clinical models as well as post-hoc analyses from diabetes and obesity tria
- The evoke and evoke+ trials did not confirm superiority of semaglutide versus placebo in the reduction of progression of Alzheimer's disease, as measured by the change in Clinical Dementia Rating -- Sum of Boxes score compared to baseline. While treatment with semaglutide resulted in improvement of Alzheimer's disease-related biomarkers in both trials, this did not translate into a delay of disease progression.
- In the evoke trials with patients aged 55-85, suffering from mild cognitive impairment or mild dementia due to Alzheimer's disease, semaglutide appeared to have a safe and well-tolerated profile consistent with previous semaglutide trials. To date, more than 37 million patient-years of semaglutide exposure have occurred across
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