December 3, 2025 — Leads & Copy —
Bristol Myers Squibb will enroll more patients in its ADEPT-2 study after identifying irregularities at a small number of study sites. The decision, made in consultation with the U.S. Food and Drug Administration (FDA) and the Data Monitoring Committee (DMC), aims to maintain the integrity of the clinical research.
Following a thorough, blinded review of the ADEPT-2 study data, Bristol Myers Squibb (BMS) discovered irregularities in clinical trial execution at a limited number of study sites. Prior to database lock, the company decided to exclude patient data from those sites from the primary analysis.
After consulting with the FDA, an interim data analysis for efficacy and safety was conducted by an independent party and reviewed by the DMC.
The DMC recommended that the study continue with additional patients to reach the original target study population. BMS has agreed to this recommendation and will proceed with patient enrollment, while remaining blinded to the study data.
Laura Gault, MD, PhD, Senior Vice President, Head of Development, Neuroscience Drug Development at Bristol Myers Squibb, stated that the company agrees with the decision to continue the Phase 3 study and will move forward with recruiting additional patients. She emphasized the company’s commitment to safeguarding the integrity of its studies by excluding patient data from sites where irregularities were observed.
The ADEPT-2 study (clinicaltrials.gov, NCT06126224) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of Cobenfy in subjects with psychosis associated with Alzheimer’s disease dementia. The study is designed to evaluate the primary endpoint of changes in the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score and the key secondary endpoint of Clinical Global Impression-Severity (CGI-S), with additional assessments on safety and tolerability of Cobenfy compared to placebo.
BMS is also conducting the ADEPT-1 and ADEPT-4 trials, with results expected by the end of 2026.
BMS is pursuing investigational therapies that aim to both meaningfully slow disease progression and to ease symptoms to help give patients, families and caregivers back some of what the disease has taken away.
Cobenfy is currently approved for the treatment of schizophrenia in adults and has the potential to be the first treatment in a new class of pharmacologic therapies targeting agitation and psychosis based on muscarinic receptor agonism.
Contact:
Laura Gault, MD, PhD
Senior Vice President, Head of Development, Neuroscience Drug Development
Bristol Myers Squibb
