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Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
PHASE3
NCT ID
NCT05511363
Trial Summary
This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease.
The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.
Sponsor: Karuna Therapeutics
Participants: ALL
Start: 2022-08-23
Completion: 2026-10-05
Min Age: 55 Years
Max Age: 90 Years
Eligibility Criteria
Inclusion Criteria: * Is aged 55 to 90 years, inclusive, at Screening * Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met. i) The subject's legally acceptable representative must provide informed consent; ii) The subject must provide informed consent. * Meets clinical criteria for possible or probable Alzheimer's Disease * Has a Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome. If not available, a non-contrast brain MRI or non-contrast head CT must be done during screening. * Living at the same location for a minimum of 4 weeks before Screening, with the intention of living at the same location throughout the study. * Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified caregiver or study partner who, in the investigator's judgment, has frequent and sufficient contact…
Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.