By: IPP Bureau
Last updated : December 04, 2025 3:54 pm
The company is excluding data from the affected sites to maintain the study's integrity
Bristol Myers Squibb (BMS) will expand enrollment in its Phase III ADEPT-2 trial for the Alzheimer's psychosis drug Cobenfy due to "irregularities" at a small number of study sites. The company is excluding data from the affected sites to maintain the study's integrity, a decision made in consultation with the FDA and a data monitoring committee.
Cobenfy (xanomeline/trospium chloride) is a key drug for BMS, which acquired it through a $14 billion buyout of Karuna Therapeutics in 2023. It is already FDA-approved for the treatment of schizophrenia in adults.
BMS identified issues with how the trial was conducted at a few locations and decided to exclude the data from those patients to safeguard the study's integrity. The specific nature of the irregularities has not been publicly detailed beyond "clinical trial execution" issues.
BMS remains blinded to the study data and emphasizes that this process ensures the scientific rigor and integrity of the trial.
A Data Monitoring Committee (DMC) reviewed the analysis and recommended continuing the study with additional patient enrollment, a decision BMS has agreed to implement.
The ADEPT program (including studies ADEPT-1, ADEPT-2, and ADEPT-4) is crucial for seeking approval for the new indication of psychosis associated with Alzheimer's disease.
BMS is pursuing a dual approach in Alzheimer’s research, developing therapies aimed at both slowing disease progression and alleviating symptoms, providing relief to patients, families, and caregivers.
ADEPT-2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating Cobenfy in patients with psychosis associated with Alzheimer’s disease dementia.
The trial’s primary endpoint is changes in the Neuropsychiatric Inventory-Clinician (NPI-C) Hallucinations and Delusions score, with key secondary measures including Clinical Global Impression-Severity (CGI-S) and additional safety and tolerability assessments.