Bristol Myers Squibb to Continue ADEPT-2 Phase 3 Alzheimer’s Psychosis Study After Data Committee Review

Study Integrity Preserved as Additional Patient Enrollment Commences

Bristol Myers Squibb (BMS) has announced a key development for its ADEPT-2 Phase 3 clinical trial focused on treating psychosis associated with Alzheimer’s disease. After identifying irregularities in data collection at a handful of study sites, BMS made the decision to exclude those sites from its primary analysis and conduct an independent, blinded interim data review. Following this analysis—and with the full support of the U.S. Food and Drug Administration (FDA) and an independent Data Monitoring Committee (DMC)—BMS will now enroll additional patients, ensuring robust and credible trial outcomes.

Data Monitoring Committee and FDA Back Study Continuation

The DMC, following its interim assessment, recommended continuation of the ADEPT-2 trial to strengthen the original target population. This process reflects industry-standard safeguards to uphold clinical trial quality. BMS remains blinded to ongoing results, underscoring the company’s commitment to scientific rigor and integrity, particularly in a high-need area such as psychosis in Alzheimer’s disease, which currently lacks adequate therapeutic solutions.

What is ADEPT-2 Evaluating? Key Trial Features

The ADEPT-2 study (clinicaltrials.gov, NCT06126224) is a randomized, double-blind, placebo-controlled trial assessing BMS’s investigational drug Cobenfy in patients experiencing psychosis due to Alzheimer’s dementia. The primary endpoint focuses on changes in hallucinations and delusions measured by the Neuropsychiatric Inventory-Clinician (NPI-C), while the secondary endpoint examines changes in the Clinical Global Impression-Severity (CGI-S) scale. Safety and tolerability are also key assessments compared to placebo. These results will contribute to broader trial readouts from the ADEPT program, with major data releases expected by the end of 2026.

Cobenfy: New Class Potential for Alzheimer’s-Related Psychosis

Cobenfy, already approved for schizophrenia in adults, is being positioned as a potential first-in-class therapy targeting psychosis and agitation in Alzheimer’s patients through muscarinic receptor agonism. Should the ongoing trial meet its endpoints, Cobenfy may offer the first targeted therapy in this domain, a critical area given the growing Alzheimer’s patient population and lack of existing treatment options.

Holistic Strategy in Alzheimer’s Therapeutics

BMS’s pipeline in Alzheimer’s isn’t limited to symptomatic treatment. The company is also investing in approaches aimed at slowing disease progression, with a goal of both improving quality of life for patients and supporting caregivers. This multifaceted effort includes several trials within the ADEPT program (ADEPT-1, ADEPT-2, ADEPT-4), all expected to have data available by 2026, further positioning BMS as a potential leader in the space.

Forward-Looking Outlook and Risks

While today’s announcement signals BMS’s commitment to research standards and transparency, future outcomes remain dependent on the completion of ongoing trials. Investors and stakeholders should keep in mind the inherent uncertainties of late-stage drug development—unfavorable data, delays, or regulatory shifts could alter the program’s trajectory. Continued attention to interim updates and forthcoming readouts will be crucial for anyone tracking progress in neuropsychiatric therapies.

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