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KarX-EC / KarXT / Alzheimer's Disease · Phase 3 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a trial registration for MINDSET 2, a Phase 3 study of KarXT + KarX-EC in Alzheimer's disease cognitive impairment. The trial is currently recruiting and no efficacy or safety results have been reported. The planned sample size and primary outcome measures (ADAS-Cog11 and CIBIC+ at week 24) are appropriate for a pivotal trial, but clinical utility cannot be assessed until results are available.
Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Alzheimer's Disease; age from 60 Years; to 85 Years. Intervention: KarXT + KarX-EC. Compared with: Placebo — Placebo Comparator. n = 586. 126 sites across 17 countries.
This is a trial registration for MINDSET 2, a Phase 3 study of KarXT + KarX-EC in Alzheimer's disease cognitive impairment. The trial is currently recruiting and no efficacy or safety results have been reported. The planned sample size and primary outcome measures (ADAS-Cog11 and CIBIC+ at week 24) are appropriate for a pivotal trial, but clinical utility cannot be assessed until results are available.
Follow-up duration beyond week 24 and safety data collection periods not stated.
The source did not state who this applies to in practice.
This is a Phase 3 trial registration with no results posted; the study is actively recruiting and outcomes have not yet been reported.
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 (NCT06976203). This is a study registration, not published results. Lead sponsor: Bristol-Myers Squibb. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 586 participants (ESTIMATED). Conditions: Alzheimer's Disease. Interventions: DRUG: KarXT; DRUG: KarX-EC; OTHER: Placebo. Primary outcome measures: Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) , At week 24; Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) , At week 24. Brief summary: The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.