MK-8189 Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis (MK-8189-017)
CompletedPhase 1Results postedLast updated 25 September 2024
What this trial tests
Phase 1 trial testing MK-8189 in Alzheimer's Disease in 29 participants. Completed in 10 January 2023.
Adults 65 to 85, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Experienced an Adverse Event (AE)Primary· Up to approximately 42 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Results are reported according to dose.
Group
Value
95% CI
MK-8189 8 mg
3
MK-8189 16 mg
8
MK-8189 24 mg
5
Placebo
1
Number of Participants Discontinuing From Study Therapy Due to AEPrimary· Up to approximately 42 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Results are reported according to dose.
Group
Value
95% CI
MK-8189 8 mg
1
MK-8189 16 mg
0
MK-8189 24 mg
0
Placebo
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 42 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of MK-8189 in participants with Alzheimer's Disease (AD) with or without symptoms of agitation-aggression and/or psychosis.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06273774 — A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)
· Phase 1
· completed
NCT05953740 — A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)
· Phase 1
· completed
NCT05893862 — A Study To Evaluate The Effect Of A Supratherapeutic Dose Of MK-8189 On The QTc Interval In Participants With Schizophre
· Phase 1
· completed
NCT05406440 — A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014)
· Phase 1
· completed
NCT04676425 — A Study to Investigate the Influence of Hepatic Impairment on MK-8189 Treatment (MK-8189-012)
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 25 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05227118.