Merck Calls Off Trial of Verubecestat as Treatment for Mild-to-Moderate Alzheimer’s

Merck Calls Off Trial of Verubecestat as Treatment for Mild-to-Moderate Alzheimer’s
Merck is calling off its Phase 2 and 3 EPOCH trial of verubecestat as a treatment for mild-to-moderate Alzheimer’s disease because preliminary results indicate it is not effective. The decision was made after an external review board known as the Data Monitoring Committee (eDMC) reported there was “virtually no chance of finding a positive clinical effect” from the trial. The product's safety was not at issue, the committee said. The committee also recommended that Merck continue its APECS study, which is examining verubecestat's effect on patients with an earlier stage of Alzheimer's — known as prodromal Alzheimer’s — or people with memory problems who are still functionally independent. Verubecestat is a small inhibitor of the beta-site amyloid precursor protein that is involved in the development of Alzheimer’s. It acts by cleaving to, and therefore deactivating, the BACE1 enzyme. That short-circuiting contributes to the accumulation of faulty beta-amyloid in neurons, disrupting their activity. The EPOCH study (NCT01739348) was a placebo-controlled, randomized trial evaluating the safety and effectiveness of two oral doses of verubecestat — 12 mg and 40 mg. Some patients got a 12-mg dose once a day, others a 40-mg dose, and others a placebo. The 78-week study involved patients with mild-to-moderate Alzheimer’s. The primary endpoint, or measuring stick, was changes in patients' Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and in their Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) score. Results will be presented at a scientific meeti
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