Efficacy and Safety Trial of Verubecestat (MK-8931) in Participants With Prodromal Alzheimer's Disease (MK-8931-019)
Status:
Terminated
Trial end date:
2018-04-17
Target enrollment:
Participant gender:
Summary
This study consists of two parts, Part 1 and Part 2. Part 1 assesses the efficacy and safety
of verubecestat (MK-8931) compared with placebo administered for 104 weeks in the treatment
of amnestic mild cognitive impairment (aMCI) due to Alzheimer's Disease (AD), also known as
prodromal AD. Participants are randomized to receive placebo, or 12 mg or 40 mg verubecestat,
once daily. The primary study hypothesis for Part 1 is that ≥1 verubecestat dose is superior
to placebo with respect to the change from baseline in the Clinical Dementia Rating scale-Sum
of Boxes (CDR-SB) score at 104 weeks. Participants completing Part 1 may choose to
participate in Part 2, which is a long term double-blind extension to assess efficacy and
safety of verubecestat administered for up to an additional 260 weeks. In Part 2, all
participants receive either 12 mg or 40 mg verubecestat, once daily.