Elpipodect (MK-8189) Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis (MK-8189-017)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
65–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Elpipodect (MK-8189) Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis (MK-8189-017)
