mk-8189 safety and tolerability in participants with alzheimer's disease with or without symptoms of agitation-aggression and/or psychosis (mk-8189-017)

Conditions: Alzheimer's Disease

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