MK-8189 Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis (MK-8189-017)

NCT ID: NCT05227118

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-01-10

Brief Summary

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MK-8189

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 Type: EXPERIMENTAL

MK-8189

Intervention Type: DRUG

MK-8189 administered orally once a day (QD) at a titration via tablet in 4 mg and 12 mg dose strengths

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

MK-8189 matching placebo administered orally QD

Interventions

MK-8189

MK-8189 administered orally once a day (QD) at a titration via tablet in 4 mg and 12 mg dose strengths

Intervention Type: DRUG

Placebo

MK-8189 matching placebo administered orally QD

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Has a history of cancer (malignancy). Exceptions: (1) Adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or; (2) Other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study
• Has a family history of long QT syndrome
• Previously developed severe extrapyramidal symptoms (EPS) following administration of any prescribed medication or study treatment
• Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
• Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-study (screening) visit
• Consumes greater than 3 glasses of alcoholic beverages per day
• Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
• Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 years

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

CITrials ( Site 0007)

Santa Ana, California, United States

Top Medical Research ( Site 0005)

Cutler Bay, Florida, United States

Velocity Clinical Research, Hallandale Beach ( Site 0001)

Hallandale, Florida, United States

Well Pharma Medical Research, Corp. ( Site 0006)

Miami, Florida, United States

Atlanta Center for Medical Research ( Site 0004)

Atlanta, Georgia, United States

iResearch Atlanta ( Site 0009)

Decatur, Georgia, United States

Global Medical Institutes LLC; Princeton Medical Institute ( Site 0008)

Princeton, New Jersey, United States

Richmond Behavioral Associates ( Site 0003)

Staten Island, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

MK-8189-017

Identifier Type: OTHER

Identifier Source: secondary_id

8189-017

Identifier Type: -

Identifier Source: org_study_id