NCT03740178

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

A Randomized, Double-Blinded Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of MK-4334 in Participants With Alzheimer's Clinical Syndrome on a Stable Dose of Donepezil

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	MK-4334	Participants with Alzheimer's clinical syndrome (MCI or mild/moderate AD) will receive MK-4334 capsules administered orally, QD on Days 1-14. Participants will receive an initial loading dose of 120 mg (Day 1), followed by a maintenance dose of 60 mg (Days 2-14). Open-label donepezil tablets (dose strength: 10 mg) administered orally, QD on Days 1-14.
DRUG	Placebo to MK-4334	Participants with Alzheimer's clinical syndrome (MCI or mild/moderate AD)will receive placebo capsules matching MK-4334 administered orally, QD on Days 1-14. Participants will also receive open-label donepezil tablets (dose strength: 10 mg) administered orally, QD on Days 1-14.
DRUG	Donepepzil	Participants with Alzheimer's clinical syndrome (MCI or mild/moderate AD) will receive open-label, oral donepezil 10 mg QD on Days 1-14.

Timeline

• Start date: 2019-09-27
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2018-11-14
• Last updated: 2025-04-25

Regulatory

• FDA-regulated drug study