Alzheimer's patients have been dealt a blow after disappointing results from a major trial. Novo Nordisk has announced that trials of its Alzheimer’s treatment have not shown a “statistically significant” reduction in progression of the condition.

The firm has today announced the main results from a two-year primary analysis of so-called Evoke and Evoke+ phase 3 trials in early-stage symptomatic Alzheimer’s disease. Evoke was testing semaglutide in people with early-stage Alzheimer's disease. Evoke+ was testing semaglutide but expanding to a broader population - allowing people who have extensive small blood vessel damage in the brain.

There had been huge expectation that the trials could lead to a breakthrough. The Alzheimers Association had said: "The results could have far-reaching implications. If semaglutide proves effective, it would be the first drug originally approved for another condition to be repurposed and made widely available for Alzheimer's treatment. Because semaglutide is already on the market and Food and Drug Administration (FDA)-approved for other health conditions, access could potentially happen much faster than with a brand-new medication.

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"If the data are positive, the drug's manufacturer, Novo Nordisk, may apply for regulatory approval to market semaglutide for Alzheimer's disease. This process will involve careful review of safety and efficacy by the FDA and other global agencies, and decisions about how and when the drug can be prescribed."

Yet the firm - one of Europe's biggest listed companies - said today that the two trials had not been the success some had anticipated. They said they had "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 trials," they added.

The firm said in a statement: "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 (CDR-SB) 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 diverse patient populations."

Martin Holst Lange, chief scientific officer and executive vice president of Research and Development at Novo Nordisk, said: “Based on the significant unmet need in Alzheimer’s disease as well as a number of indicative data points, we felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success. We are proud to have conducted two well-controlled phase 3 trials in Alzheimer’s disease that meet the highest standards of research and rigorous methodology. We sincerely thank all participants and their caregivers for their meaningful contributions. While semaglutide did not demonstrate efficacy in slowing the progression of Alzheimer’s disease, the extensive body of evidence supporting semaglutide continues to provide benefits for individuals with type 2 diabetes, obesity, and related comorbidities.”

The company said a 1-year extension period in the Evoke and Evoke+ trials will be "discontinued based on the efficacy results observed in the overall study population". Shares in Novo Nordisk fell 12 per after the news was issued.