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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 42 days

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

Dizziness

Akathisia

Nausea

Fatigue

Dyspepsia

Lethargy

Agitation

Schizophrenia

Somnolence

Decreased appetite

Vomiting

Anxiety

Alcohol poisoning

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met