On 11 April, investigators of the verubevestat trial published findings of the prodromal Alzheimer’s disease (AD) trial in The New England Journal of Medicine. The publication of the trials’ results follows the announcement of the discontinuation of the Phase III APECS study during the CTAD conference in February. The APECS trial was a randomised, placebo-controlled, parallel-group, double-blind Phase III clinical trial evaluating the efficacy and safety of verubecestat in people with prodromal AD – an early phase of AD in which people have memory problems as well as positive biomarkers for the disease, but remain independent. Verubecestat belongs to a group of AD drugs called BACE inhibitors which block the production of the beta-secretase enzyme involved in the formation of toxic amyloid proteins. The trial enrolled 1,454 participants who either received a daily dose of 12 mg (485 participants), 40 mg (484 participants) or a placebo (485 participants).
All in all, 704 participants had enrolled in the post-test after participation during two years. In these, results from the administered pen and paper test suggested a worse outcome in those taking verubecestat than in participants who took the placebo. Furthermore, the investigators reported that adverse events were also more common in the verubecestat group compared to those who took the placebo. Participants who enrolled later were withdrawn from the study due to the termination. Detailed results can be found in the publication: https://www.nejm.org/doi/pdf/10.1056/NEJMoa1812840
