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

• Status: Not yet recruiting
• Trial end date: 2023-07-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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

• 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