Status:
COMPLETED
MK-8189 Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis (MK-8189-017)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
65-85 years
Phase:
PHASE1
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-aggressi...
Eligibility Criteria
Inclusion
- The main inclusion and exclusion criteria include but are not limited to the following:
- 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
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05227118
Start Date
July 1 2022
End Date
January 10 2023
Last Update
September 25 2024
Active Locations (8)
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1
CITrials ( Site 0007)
Santa Ana, California, United States, 92705
2
Top Medical Research ( Site 0005)
Cutler Bay, Florida, United States, 33189
3
Velocity Clinical Research, Hallandale Beach ( Site 0001)
Hallandale, Florida, United States, 33009
4
Well Pharma Medical Research, Corp. ( Site 0006)
Miami, Florida, United States, 33173