NCT04308304

MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005)

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Pharmacokinetics of MK-1942 Administered to Alzheimer's Disease Patients Receiving Donepezil Treatment.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	MK-1942	MK-1942 1 mg, 5 mg, and/or 10 mg capsules taken twice daily (BID) by mouth.
DRUG	Donepezil	Donepezil 5 mg and/or 10 mg tablets taken once daily (QD) by mouth.
DRUG	Placebo	Placebo capsule matched to MK-1942 taken BID by mouth.

Timeline

• Start date: 2021-02-16
• Primary completion: 2022-05-18
• Completion: 2022-05-18
• First posted: 2020-03-16
• Last updated: 2024-08-15
• Results posted: 2024-08-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study