Study Evaluating Verubecestat in Prodromal Alzheimer’s Disease Stopped

APECS is a randomized, placebo-controlled, parallel-group, double-blind Phase 3 clinical trial evaluating the efficacy and safety of verubecestat in people with prodromal AD.

Merck announced the discontinuation of the Phase 3 APECS study (protocol 019) evaluating verubecestat (MK-8931) for the treatment of patients with prodromal Alzheimer’s disease

APECS was a randomized, placebo-controlled, parallel-group, double-blind study (N=1,350) that enrolled patients aged 50–85 years with prodromal Alzheimer’s disease. They were randomized to verubecestat 12mg, verubecestat 40mg or placebo once daily. The primary efficacy outcome was the change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score following 104 weeks of treatment. 

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Verubecestat is a small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme (BACE1). The decision to halt the study came after review of the overall benefit and risk associated with the drug during an interim safety analysis. The Data Monitoring Committee concluded that it was unlikely that positive benefit/risk for investigational verubecestat could be established if the study continued. 

Findings from the APECS study will be announced at a future medical meeting. 

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