Bristol Myers Squibb Extends Cobenfy Trial in Alzheimer’s Psychosis After DMC Recommendation | iPharmaCenter
- Badari Andukuri
- 21 hours ago
- 2 min read
Updated: 1 hour ago
Bristol Myers Squibb is extending enrollment in its pivotal ADEPT-2 Phase 3 trial of Cobenfy in psychosis associated with Alzheimer’s disease, following a review of site-level data and a recommendation from the study’s independent Data Monitoring Committee (DMC). The company remains blinded to efficacy and safety outcomes from the study.
Study continuation after data review
During a blinded quality review of ADEPT-2, BMS identified protocol execution issues at a small number of trial sites and decided to exclude data from those centers from the primary analysis before locking the database. After discussion with the U.S. Food and Drug Administration, an independent group performed an interim efficacy and safety analysis using the remaining data, which was then evaluated by the DMC.
Based on this review, the DMC recommended that ADEPT-2 continue and that additional patients be enrolled to meet the trial’s original target population. BMS has accepted this guidance and will keep recruiting participants while advancing the broader ADEPT program as initially planned.
Cobenfy’s role in Alzheimer’s psychosis
Cobenfy (xanomeline and trospium chloride) is an oral muscarinic receptor agonist already approved in the United States for the treatment of schizophrenia in adults. BMS views the drug as a potential first-in-class option for agitation and psychosis in Alzheimer’s disease, offering a mechanism distinct from traditional antipsychotics.
The company expects further data from the ADEPT clinical program in Alzheimer’s disease psychosis, including ADEPT-2, ADEPT-1 and ADEPT-4, to become available by the end of 2026. Management has indicated that positive results from at least two of the three studies would be needed to support a regulatory submission in this indication.
About the ADEPT-2 trial
ADEPT-2 (NCT06126224) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Cobenfy in patients with psychosis associated with Alzheimer’s disease dementia. The primary endpoint is change from baseline in the Neuropsychiatric Inventory–Clinician (NPI-C) Hallucinations and Delusions score, reflecting core psychotic symptoms.
Key secondary outcomes include the Clinical Global Impression–Severity (CGI-S) scale, alongside a broader assessment of safety and tolerability versus placebo. ADEPT-2 enrolls individuals across multiple international sites spanning a range of Alzheimer’s disease severity to better capture real-world psychosis presentations.