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KarXT / Psychosis Associated With Alzheimer's Disease · Phase 3 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 3 randomized controlled trial evaluating KarXT for psychosis associated with Alzheimer's disease, with relapse prevention as the primary endpoint measured at 38 weeks. No results are reported in this registry record; the trial is currently recruiting.
Phase 3, Interventional, Randomized, Single Group, Quadruple masking, Treatment purpose. Psychosis Associated With Alzheimer's Disease; age from 55 Years; to 90 Years. Intervention: KarXT. Compared with: Placebo — Placebo Comparator. n = 410. 129 sites across 13 countries.
This is a planned Phase 3 randomized controlled trial evaluating KarXT for psychosis associated with Alzheimer's disease, with relapse prevention as the primary endpoint measured at 38 weeks. No results are reported in this registry record; the trial is currently recruiting.
This is a registry record only; no efficacy or safety results are reported
The source did not state who this applies to in practice.
This is a clinical trial registry record describing a planned Phase 3 study with no results yet reported; the protocol and design are established but outcome data are absent.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05511363). This is a study registration, not published results. Lead sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 410 participants (ESTIMATED). Conditions: Psychosis Associated With Alzheimer's Disease. Interventions: DRUG: KarXT; DRUG: Placebo. Primary outcome measures: Time from randomization to relapse , Week 38. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.