Elpipodect (MK-8189) Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis (MK-8189-017)
A Randomized Clinical Study to Evaluate the Safety and Tolerability of MK-8189 in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis
2 other identifiers
interventional
29
1 country
8
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of elpipodect in participants with Alzheimer's Disease (AD) with or without symptoms of agitation-aggression and/or psychosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2022
Shorter than P25 for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2023
CompletedResults Posted
Study results publicly available
September 25, 2024
CompletedApril 29, 2026
April 1, 2026
6 months
January 27, 2022
December 15, 2023
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants Who Experienced an Adverse Event (AE)
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.
Up to approximately 42 days
Number of Participants Discontinuing From Study Therapy Due to AE
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.
Up to approximately 42 days
Study Arms (2)
Elpipodect
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
MK-8189 administered orally once a day (QD) at a titration via tablet in 4 mg and 12 mg dose strengths
Eligibility Criteria
You may not qualify if:
- Has a documented diagnosis of probable Alzheimer Disease based on National Institute on Aging-Alzheimer Association criteria for AD, with a history of cognitive and functional decline with gradual onset and slow progression for at least 1 year before screening, that is either corroborated by an informant who knows the participant well or is documented in medical records
- Lives in the community setting with a reliable trial partner/caregiver or lives alone in an assisted living facility, with supervision and has a reliable trial partner/caregiver
- Has a reliable and competent trial partner/caregiver who must have a close relationship with the participant and is knowledgeable of the participant's condition and progress and able to read, understand and speak the designated language at the study site
- Can read at the 6th grade level/equivalent as determined by the investigator
- Has an academic and/or employment history sufficient to exclude intellectual disability and is able, in the opinion of the investigator, to fully participate in the study
- Participants receiving treatment with a cholinesterase inhibitor or other treatment for AD, must have been on a stable regimen for 3 months prior to screening and there are no expected changes in co-medication during the study
- Is able to discontinue any antipsychotic medication they are taking at the time of Screening
- Has a body mass index (BMI) \> 18 and ≤ 35kg/m2, inclusive
- Has agitation/aggression or psychosis that is attributable to concomitant medications, environmental conditions, substance abuse, or an active medical or psychiatric condition
- Has a known history of stroke or evidence from prior magnetic resonance imaging (MRI) scan (if available) that is clinically important in the investigator's opinion
- Has evidence of a clinically relevant neurological disorder other than the disease being studied (i.e., probable AD) at Screening
- Has a history of seizures or epilepsy within the last 5 years before Screening
- Has evidence of a clinically relevant or unstable psychiatric disorder
- Is at imminent risk of self-harm
- Has a history of alcoholism or drug dependency/abuse within the last 5 years before Screening
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
CITrials ( Site 0007)
Santa Ana, California, 92705, United States
Top Medical Research ( Site 0005)
Cutler Bay, Florida, 33189, United States
Velocity Clinical Research, Hallandale Beach ( Site 0001)
Hallandale, Florida, 33009, United States
Well Pharma Medical Research, Corp. ( Site 0006)
Miami, Florida, 33173, United States
Atlanta Center for Medical Research ( Site 0004)
Atlanta, Georgia, 30331, United States
iResearch Atlanta ( Site 0009)
Decatur, Georgia, 30030, United States
Global Medical Institutes LLC; Princeton Medical Institute ( Site 0008)
Princeton, New Jersey, 08540, United States
Richmond Behavioral Associates ( Site 0003)
Staten Island, New York, 10314, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 7, 2022
Study Start
July 1, 2022
Primary Completion
January 10, 2023
Study Completion
January 10, 2023
Last Updated
April 29, 2026
Results First Posted
September 25, 2024
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf