drugset / Trial / NCT03740178

Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)

NCT03740178

Phase 1 Withdrawn Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of MK-4334 administered once daily (QD) in participants with Alzheimer's clinical syndrome receiving a stable, daily dose of donepezil 10 mg, taken orally (PO). This includes participants with symptoms of mild cognitive impairment (MCI) or mild to moderate Alzheimer's disease (AD). It is hypothesized that the true geometric mean minimum plasma concentration at 24 hours (C24) is at least 60 nM at steady state in the presence of steady-state donepezil 10 mg.

Timeline

Start
2019-09-27
Primary completion
2020-02-28
Completion
2020-02-28

Drugs

EvaluationDrugModalityDoseRoute
Background Donepezil Small molecule 60 mg Oral
Background Donepezil Small molecule 10 mg Oral