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MK-8189 Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis (MK-8189-017)
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
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 42 days
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 • NCT0305533818%
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
~1180
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,189,813 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,091,440 Total Patients Enrolled