Efficacy and Safety of MK-7622 as Adjunct Therapy in Participants With Alzheimer's Disease (MK-7622-012)
Status:
Terminated
Trial end date:
2016-04-11
Target enrollment:
Participant gender:
Summary
The purpose of this multicenter trial is to assess the efficacy and safety of MK-7622
compared with placebo as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for
the symptomatic treatment of participants with mild to moderate Alzheimer's Disease (AD). The
trial consists of two stages: Stage 1 and Stage 2. In Stage 1, participants will be
randomized to receive either placebo or MK-7622 45 mg once daily. In Stage 2, participants
will be randomized to receive either placebo or MK-7622 (dose: 5, 15 or 45 mg once daily).
Participants will be enrolled in only one stage; the duration of each stage is approximately
26 weeks. Interim analyses will be performed in both Stage 1 and Stage 2 to determine whether
the trial should continue. The primary study hypotheses are the following: Stage 1 - MK-7622
45 mg once daily is superior to placebo with respect to improving cognition in participants
with mild to moderate AD as assessed by mean change from baseline in the 11-item Alzheimer's
Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Week 12; Stage 2 - At least one
of the top two doses of MK-7622 (15 mg once daily, 45 mg once daily) is superior to placebo
with respect to improving cognition in participants with mild to moderate AD as assessed by
mean change from baseline in ADAS-Cog11 at Week 12.