Phase III APECS study of MK 8931 halted in Alzheimer's disease, the second trial of the drug to be cancelled.- Merck Inc.
Merck Inc announced that it will be stopping protocol 019, also known as the APECS study, a Phase III study evaluating MK 8931 (verubecestat), an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), in people with prodromal Alzheimer's disease (AD).
The decision to stop the study follows a recommendation by the external Data Monitoring Committee (eDMC), which assessed overall benefit/risk during a recent interim safety analysis. The eDMC concluded that it was unlikely that positive benefit/risk could be established if the trial continued. Data from the APECS study will be presented at an upcoming medical meeting.
This decision comes 1 year after Merck Inc stopped protocol 017, also known as the EPOCH study, under similar conditions.
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