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KarXT / Psychosis Associated With Alzheimer's Disease · Phase 3 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 3 randomized controlled trial comparing KarXT to placebo for psychosis in Alzheimer's disease, currently recruiting. No results are available in this registry record; the study design meets rigorous standards but evidence strength cannot be judged until outcomes are reported.
Phase 3, Interventional, Randomized, Parallel, 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 = 500. 154 sites across 14 countries.
This is a registered Phase 3 randomized controlled trial comparing KarXT to placebo for psychosis in Alzheimer's disease, currently recruiting. No results are available in this registry record; the study design meets rigorous standards but evidence strength cannot be judged until outcomes are reported.
No secondary outcomes, safety data, or interim analyses are described in this record. Efficacy and safety cannot be assessed until trial completion and results publication.
The source did not state who this applies to in practice.
This is a registry record for a Phase 3 trial currently recruiting; no results are posted, so evidence strength cannot be assessed.
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 (NCT06126224). 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: 500 participants (ESTIMATED). Conditions: Psychosis Associated With Alzheimer's Disease. Interventions: DRUG: KarXT; DRUG: Placebo. Primary outcome measures: Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score , Baseline and end of Treatment (up to 14 Weeks). Brief summary: This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.