Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.
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Study Overview: Bristol-Myers Squibb is conducting 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-2). The study aims to assess the safety and efficacy of KarXT + KarX-EC in treating agitation in Alzheimer’s patients, a significant concern due to its impact on patient quality of life and caregiver burden.
Intervention/Treatment: The study tests two drugs: Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule, intended to reduce agitation symptoms in Alzheimer’s patients. These are compared against a placebo to evaluate their effectiveness.
Study Design: This interventional study is randomized and uses a parallel assignment model. It is quadruple-masked, meaning that the participant, care provider, investigator, and outcomes assessor are unaware of the treatment allocations. The primary purpose is treatment-focused.
Study Timeline: The study began on July 18, 2025, with an estimated start date. The primary completion and estimated completion dates have not been disclosed yet. The last update was submitted on July 15, 2025, indicating ongoing recruitment.
Market Implications: This study could significantly impact Bristol-Myers Squibb’s stock performance and investor sentiment, as successful results may lead to a new treatment option for Alzheimer’s-related agitation. This could position the company favorably against competitors in the Alzheimer’s treatment market.
The study is currently recruiting, with further details available on the ClinicalTrials portal.