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MK-1942 for Alzheimer's Disease (DDI Trial)

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 7, 14, 21, and 28
Awards & highlights

Summary

This trial is testing a new drug, MK-1942, together with an existing Alzheimer's medication, donepezil. It focuses on patients with mild-to-moderate Alzheimer's who are already taking donepezil. The study aims to see if this combination is safe and if it causes any new or more severe side effects. Researchers will also check how the body processes both drugs when taken together. Donepezil is a well-established treatment for Alzheimer's disease, used to improve cognition and global function in patients with mild to severe stages of the disease.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 7, 14, 21, and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 7, 14, 21, and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmaceutical Preparations
Number of Participants Experiencing an Adverse Event (AE)
Number of Participants Who Reported Suicidal Ideation and/or Behavior on Study Based on Responses to the Columbia Suicide Severity Rating Scale (C-SSRS)
+8 more
Secondary outcome measures
Amount of Drug in the Plasma from the Dose to Hour 12 (AUC0-12) of MK-1942
Amount of Drug in the Plasma from the Dose to Hour 24 (AUC0-24) of Donepezil
Amount of Drug in the Plasma from the Dose to Hour 24 (AUC0-24) of MK-1942
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-1942Experimental Treatment2 Interventions
Dose Level 1: 8-mg MK-1942 twice daily (BID) x 7 days (7D), Day 1 to Day 7; Dose Level 2: 15-mg MK-1942 BID x 7D, Day 8 to Day 14; Dose Level 3: 30-mg MK-1942 BID x 7D, Day 15 to Day 21; Dose Level 4: ≤50-mg MK-1942 BID x 7D (Provisional Dose Level), Day 22 to Day 28 All participants to receive Donepezil once daily.
Group II: PlaceboPlacebo Group2 Interventions
Placebo to MK-1942 BID x 21 [28] D All participants to receive Donepezil once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-1942
2021
Completed Phase 1
~30
Donepezil
2011
Completed Phase 4
~2070

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,985 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,068,236 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,070,303 Total Patients Enrolled
~6 spots leftby Sep 2025
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