At a glance
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A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Pharmacokinetics of MK-1942 Administered to Alzheimer's Disease Patients Receiving Donepezil Treatment.
In Brief
A Phase 1 clinical trial evaluating MK-1942, Donepezil, and 1 other intervention for Alzheimer's Disease. Completed, enrolled 27 participants across 4 sites.
Detailed Summary
The study investigated the effects on safety and pharmacokinetics (PK) of MK-1942 and donepezil when co-administered to participants with Alzheimer's Disease with mild-to-moderate cognitive impairment stably treated with donepezil. The objectives of this study were to determine if the combination of MK-1942 with donepezil increases the incidence or severity of adverse events (AEs) previously reported for these agents alone, or results in unanticipated AEs in the patient population targeted for MK-1942 treatment. In addition, changes in the PK parameters of either MK-1942 or donepezil as a result of co-administration were assessed.
Study Details
Timeline
Interventions
MK-1942 1 mg, 5 mg, and/or 10 mg capsules taken twice daily (BID) by mouth.
Donepezil 5 mg and/or 10 mg tablets taken once daily (QD) by mouth.
Placebo capsule matched to MK-1942 taken BID by mouth.