Eligibility
Participants can be no younger than Matt Damon’s current age, which is this double number
What is 55?
An MRI/CT scan is only needed at screening if one has not been completed within this period of time
What is the past five years?
The placebo run-in period during which all participants will receive single-blinded placebo will last for this amount of time
What is 2 weeks?
This rating scale is used to assess the severity of drug-induce akathisia
What is BARS (Barnes Akathisia Rating Scale)?
This vendor is the Central Lab and will provide required kits for this study
What is Labcorp?
CGI-S requires the assessor to consider these two aspects of the psychosis prior to providing a global assessment of severity
What are hallucinations and delusions?
This safety assessment should be administered during unscheduled visits. Administration of assessments marked with an “X” in the SOA of the protocol should be performed if possible
What is C-SSRS?
Each participant will be titrated to this maximum dose of KarXT + KarX-EC (or matching placebo) based on tolerability and efficacy
What is 224/24 mg/day?
This efficacy assessment which measures hallucinations, delusions, agitation, and aggression domains should be performed before all other scales during all visits at which it is administered
What is the NPI-C Core Score (Neuropsychiatric Inventory – Clinical Core Scale)?
This vendor will manage randomization, IMP dispensation and is the source for unblinding study participants
What is Endpoint?
If a participant is deemed not competent to provide IC, the participant must provide informed assent and this individual, known as the LAR, must provide IC
Who is their legally acceptable representative?
These study visits will be administered via telephone
What are visits 3, 5, and 7?
During the randomized treatment period, participants need to reach this minimum dose of IMP by the end of Week 6 and be maintained on this dose to stay in the study
What is 168/18 mg/day?
This rater-led interview asks a caregiver to rate 29 items used to assess the frequency of manifestations of agitated behaviors in older adults
What is the CMAI (Cohen-Mansfield Agitation Inventory)?
This vendor will ensure that potential study participants are not currently enrolled in another clinical trial
What is Verified Clinical Trials (VCT) Services?
The participant must have an MMSE score, which stands for this, of 8 to 22, inclusive, at screening (Visit 1) to be eligible for this study
What is Mini-Mental State Examination?
Participants who plan to enroll in the OLE must provide IC by this visit
What is Visit 12/EOT/ET?
The IMP (KarXT and KarX-EC or matching placebo) should be taken daily BID on an empty stomach, at least this amount of time before a meal or at least this amount of time after a meal
What is 1 hour before a meal or 2 hours after a meal?
This assessment is used to measure relationships with friends and family, concerns about finances, physical condition, and mood at the present time
What is the QoL-AD (Quality of Life in Alzheimer’s Disease)?
This vendor will ensure patient safety by monitoring cardiac and respiratory function
What is Clario?
Individuals who answer “yes” on items 3, 4, or 5 (C-SSRS-ideation) within this amount of time before screening are ineligible for the study
What is 2 months?
Participants who do not enter the OLE should complete a SFU visit at the end of this week
What is Week 16?
Each bottle of IMP will contain enough doses for this number of days
What is 15 days?
This questionnaire is only administered to male participants and is used to assess severity of benign prostatic hyperplasia
What is IPSS (International Prostate Symptom Score)?
This vendor is responsible for ensuring that individuals are compensated for their participation in this study
What is Greenphire?