Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.
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Study Overview: Bristol-Myers Squibb is initiating a Phase 3 clinical study titled ‘A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer’s Disease (ADAGIO-1)’. The study aims to assess the safety and efficacy of the drug combination KarXT + KarX-EC in treating agitation in Alzheimer’s patients, a significant concern in managing this condition.
Intervention/Treatment: The study tests two drugs: Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule. These drugs are designed to address agitation symptoms in Alzheimer’s patients.
Study Design: This is an interventional study with a randomized, double-blind, placebo-controlled, parallel-group design. The primary goal is treatment, with participants, care providers, investigators, and outcomes assessors all blinded to the group assignments.
Study Timeline: The study is not yet recruiting, with an estimated start date of July 18, 2025. The study was first submitted on June 2, 2025, and the latest update was on July 7, 2025. These dates are crucial for tracking the study’s progress and potential market entry.
Market Implications: The initiation of this study could positively influence Bristol-Myers Squibb’s stock performance by showcasing their commitment to addressing Alzheimer’s-related challenges. Successful outcomes may enhance investor confidence and position the company favorably against competitors in the Alzheimer’s treatment market.
The study is ongoing, with further details available on the ClinicalTrials portal.