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MK-8189 for Alzheimer's Disease

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The main inclusion
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 42 days
Awards & highlights

Summary

This trial is testing a new drug called MK-8189 to see if it is safe for people with Alzheimer's Disease. The study includes patients who may have symptoms like agitation, aggression, or psychosis. Researchers are giving the drug in increasing amounts to find out the best dose that patients can handle without side effects.

Eligible Conditions
  • Alzheimer's Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Discontinuing From Study Therapy Due to AE
Number of Participants Who Experienced an Adverse Event (AE)

Side effects data

From 2018 Phase 2 trial • 224 Patients • NCT03055338
18%
Weight increased
13%
Sedation
11%
Headache
9%
Dizziness
9%
Akathisia
9%
Nausea
7%
Fatigue
7%
Dyspepsia
7%
Lethargy
7%
Agitation
4%
Schizophrenia
4%
Somnolence
2%
Decreased appetite
2%
Vomiting
2%
Anxiety
2%
Alcohol poisoning
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risperidone
MK-8189
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-8189Experimental Treatment1 Intervention
Participants will be assigned to one of the following regimens: Titration 1: 4 mg x 2 tablets Days 1-3; 4 mg x 1 tablet \& 12 mg x 1 tablet Days 4-28 OR Titration 2: 4 mg x 2 tablets Days 1-3; 4 mg x 1 tablet \& 12 mg x 1 tablet Days 4-6; 12 mg x 2 tablets Days 7-28 OR Titration 3: 4 mg x 1 tablet Days 1-3; 4 mg x 2 tablets Days 4-6; 4 mg x 1 tablet \& 12 mg x 1 tablet Days 7-9; 12 mg x 2 tablets Days 10-28.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be assigned to one of the following regimens: Titration 1: 2 tablets Days 1-28 OR Titration 2: 2 tablets Days 1-28 OR Titration 3: 1 tablet Days 1-3; 2 tablets Days 4-28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-8189
2020
Completed Phase 2
~680

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,966 Previous Clinical Trials
5,176,644 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,849 Previous Clinical Trials
8,080,851 Total Patients Enrolled
~9 spots leftby Oct 2025