Clinical trial NCT05227118: MK-8189 Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis (MK-8189-017)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 29
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: The main inclusion and exclusion criteria include but are not limited to the following:

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

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 42 days
measure: Number of Participants Discontinuing From Study Therapy Due to AE
timeFrame: Up to approximately 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: CITrials ( Site 0007)
state: California
city: Cutler Bay
country: United States
facility: Top Medical Research ( Site 0005)
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 0001)
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp. ( Site 0006)
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research ( Site 0004)
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta ( Site 0009)
state: Georgia
city: Princeton
country: United States
facility: Global Medical Institutes LLC; Princeton Medical Institute ( Site 0008)
state: New Jersey
city: Staten Island
country: United States
facility: Richmond Behavioral Associates ( Site 0003)
state: New York
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: