Actively Recruiting
Phase 3 Study to Test KarXT and KarX-EC Safety and Effectiveness for Treating Mild to Moderate Alzheimers Disease Cognitive Problems
Led by Bristol-Myers Squibb · Updated on 2026-06-26
586
Participants Needed
116
Research Sites
23 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the effects of KarXT combined with KarX-EC to treat cognitive impairment in people with mild to moderate Alzheimers Disease. This Phase 3 clinical trial aims to evaluate both the efficacy and safety of this treatment compared to a placebo, focusing on improving cognitive function and daily living activities over 24 weeks. Participants will be randomly assigned to receive either the active drugs KarXT and KarX-EC or a placebo, following specified dosing schedules. The study uses a double-blind, parallel-group design, meaning neither the participants nor the researchers know who receives the active treatment or placebo during the trial period. Participants will be monitored through various assessments including cognitive scales like the Alzheimers Disease Assessment Scale-Cognitive Subscale 11 ADAS-Cog11 and clinician interviews at baseline and week 24. Safety will be closely observed via monitoring adverse events, vital signs, laboratory tests, and heart function tests. The total duration of participation includes treatment and follow-up until study completion.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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