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 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 as it affects patient quality of life and caregiver burden.
Intervention/Treatment: The study tests two drugs, Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule, against a placebo. These drugs are designed to manage agitation symptoms in Alzheimer’s patients.
Study Design: This is a randomized, double-blind, placebo-controlled study with a parallel group design. It involves quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are all unaware of the treatment allocations. The primary purpose is treatment-focused.
Study Timeline: The study began on July 10, 2025, with the latest update submitted on August 14, 2025. These dates indicate the study is in its early stages, with recruitment ongoing, highlighting the commitment to advancing Alzheimer’s treatment options.
Market Implications: This study could significantly impact Bristol-Myers Squibb’s stock performance and investor sentiment, as successful results may enhance the company’s portfolio in the Alzheimer’s treatment market. The ongoing recruitment phase suggests potential growth opportunities, especially if the treatment proves effective, positioning BMY as a leader in addressing Alzheimer’s-related agitation.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.