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

NCT03740178 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-04-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2020-02-28
Completion
2020-02-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03740178 on ClinicalTrials.gov