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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

Study Summary

This trial will test a new drug for safety and tolerability in people with Alzheimer's, with or without symptoms of aggression and/or psychosis.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants discontinuing study treatment due to an Adverse Event (AE)
Number of participants who experienced an adverse event (AE)

Side effects data

From 2018 Phase 2 trial • 224 Patients • NCT03055338
18%
Akathisia
16%
Nausea
16%
Headache
9%
Dystonia
8%
Diarrhoea
8%
Vomiting
8%
Sedation
8%
Anxiety
7%
Decreased appetite
7%
Somnolence
7%
Insomnia
6%
Dyspepsia
3%
Dizziness
2%
Weight increased
2%
Fatigue
1%
Agitation
1%
Lethargy
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-8189
Risperidone
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
~620

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,867 Previous Clinical Trials
5,051,754 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,062,038 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial open to geriatric individuals?

"The upper and lower bounds of this clinical trial are 65 and 85 years old, respectively. Eligible participants must be within these age brackets to qualify for enrollment."

Answered by AI

In how many distinct venues is this trial currently being conducted?

"Currently, this clinical trial is being conducted across 8 different centres. Locations include Princeton, Staten Island and Miami with other cities housing the remainder of the sites. It may be beneficial to select the closest site in order to limit travel requirements if chosen as a participant."

Answered by AI

Are there openings for me to join this clinical experiment?

"To be considered for this research, candidates must display aggression and satisfy the age requirement of 65 to 85. The clinical trial has the capacity to accept 28 participants."

Answered by AI

Has the FDA approved MK-8189 for public use?

"Due to minimal safety and efficacy data, MK-8189 was given a rating of 1 on the Power scale."

Answered by AI

Are there any current opportunities to join this scientific experiment?

"The clinical trial in question, which was initially posted on July 1st 2022 and subsequently updated on November 23rd 2022, is not seeking applicants at this time. Nevertheless, there are 610 other medical studies currently accepting patients."

Answered by AI
~11 spots leftby Mar 2025