Date: 2017-02-14
Type of
information: Halting of the trial
phase: 2-3
Announcement: halting of the trial
Company: Merck&Co (USA - NJ)
Product: verubecestat (MK-8931)
Action
mechanism: BACE (beta-site APP-cleaving enzyme-1) inhibitor.
Disease: Alzheimer's Disease
Therapeutic
area: Neurodegenerative diseases
Country: Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Republic of Korea, Netherlands, New Zealand, Portugal, Spain, Turkey, UK, USA
Trial
details:
- EPOCH study is designed to evaluate the safety and efficacy of two oral doses of verubecestat (12 mg and 40 mg) administered once daily versus placebo in patients with mild-to-moderate AD currently using standard of care treatment. The primary efficacy outcomes of the study are the change from baseline in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score, as well as the change from baseline in the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) score, following 78 weeks of treatment.
- This study consists of two parts, Part I and Part II. The purpose of Part I of the study is to assess the efficacy and safety of verubecestat (MK-8931) compared with placebo administered for 78 weeks in the treatment of Alzheimer's Disease (AD). The primary study hypotheses for Part I are that at least one verubecestat dose is superior to placebo at 78 weeks of treatment with respect to change from Baseline in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and that at least one verubecestat dose is superior to placebo at 78 weeks of treatment with respect to change from Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score. The first approximately 400 participants entering Part I of the study are identified as the Safety Cohort. Participants who complete Part I of the study may choose to participate in Part II, which is a long term double-blind extension to assess efficacy and safety of verubecestat administered for up to an additional 260 weeks. (NCT01739348)
Latest
news:
- • On February 14, 2017, Merck&Co announced that it will be stopping protocol 017, also known as the EPOCH study, a Phase 2/3 study evaluating verubecestat, an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), in people with mild-to-moderate Alzheimer’s disease (AD). The company is stopping the study following the recommendation of the external Data Monitoring Committee (eDMC), which assessed overall benefit/risk during a recent interim safety analysis, and determined that there was “virtually no chance of finding a positive clinical effect.” The eDMC noted that safety signals observed in the study “are not sufficient to warrant stopping study 017,” and recommended that protocol 019, also known as APECS, which is evaluating verubecestat in people with prodromal Alzheimer’s disease, continue unchanged. Results from protocol 019 are expected in February 2019. Results from EPOCH will be analyzed and presented at an upcoming scientific meeting.
- • On January 28, 2016, Merck&Co has confirmed the completion of enrollment for the EPOCH trial, a Phase 2/3 randomized, placebo-controlled, parallel-group, double-blind study of verubecestat in patients with mild-to-moderate Alzheimer’s disease (AD). The ongoing study commenced in November 2012, completed enrollment in the fourth quarter of 2015 and is estimated to reach primary trial completion in July 2017. The ongoing EPOCH study is designed to evaluate the safety and efficacy of two oral doses of verubecestat (12 mg and 40 mg) administered once daily versus placebo in patients with mild-to-moderate AD currently using standard of care treatment. The primary efficacy outcomes of the study are the change from baseline in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score, as well as the change from baseline in the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) score, following 78 weeks of treatment. Merck is also investigating the safety and efficacy of verubecestat in the earlier, prodromal phase of AD in an additional Phase 3 clinical trial called APECS.
Is
general: Yes
