An Efficacy and Safety Trial of Verubecestat (MK-8931) in Mild to Moderate Alzheimer's Disease (P07738)
Status:
Terminated
Trial end date:
2017-04-14
Target enrollment:
Participant gender:
Summary
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.