Efficacy and Safety of MK-7622 as Adjunct Therapy in Participants With Alzheimer's Disease (MK-7622-012)
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.
Timeline
- Start
- 2013-10-22
- Primary completion
- 2016-04-11
- Completion
- 2016-04-11
Outcome
Missed primary endpoint
Stopped: “Stage 1 interim analysis of efficacy met the criteria for early trial termination (futility). The trial was terminated at Stage 1; did not proceed to Stage 2.”
paper MK-7622 did not improve cognition at 12 weeks (group difference in ADAS-Cog11: 0.18 [95% confidence interval: -1.0 to 1.3]) PMID 29955661 ↗
registry MK-7622 High Dose - 45 mg (Stage 1) vs Placebo (Stage 1); p = 0.7623; Mean Difference (Final Values) 0.18 (95% CI -1.00 to 1.37) NCT01852110 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-7622 | Small molecule | 5 mg | Oral |
| Subject | MK-7622 | Small molecule | 15 mg | Oral |
| Subject | MK-7622 | Small molecule | 45 mg | Oral |
| Background | Donepezil | Small molecule | 10 mg | Oral |
| Background | Galantamine | Small molecule | 16 mg | Oral |
| Background | Galantamine | Small molecule | 24 mg | Oral |
| Background | Rivastigmine | Small molecule | 6 mg | Oral |
| Background | Rivastigmine | Small molecule | 9.5 mg | Oral |
| Background | Rivastigmine | Small molecule | 12 mg | Oral |
| Background | Rivastigmine | Small molecule | 13.3 mg | Oral |