CN012-0034 (ADEPT-5): Phase 3 KarXT + KarX-EC for Psychosis associated with Alzheimer's Disease
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated with Alzheimer's Disease (ADEPT-5)
IRAS ID
1013937
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Research summary
This study will look at whether the study drug KarXT + KarX-EC works to treat psychosis associated with Alzheimer's disease.
The study drug is a combination of two drugs called xanomeline and trospium chloride. Xanomeline does act on two key receptor subtypes (M1 and M4), which are involved in thinking, cognition and behavioural functions. Trospium chloride helps reduce the side effects of xanomeline without reducing its beneficial effects in the brain.
The KarXT capsule contains xanomeline and trospium chloride in an immediate release capsule. The KarX-EC capsule contains xanomeline alone in a coated capsule for delayed release. The combination of both capsules offers a dual burst of xanomeline.
Participants will be randomly assigned (1:1 ratio) in one of two arms: The investigational treatment arm (KarXT + KarX-EC) or the placebo arm.
The main goal of this study is to see if KarXT + KarX-EC:
- is better than a placebo (a pill with no medicine in it) at treating psychosis in people with Alzheimer’s Disease
- causes any side effects
This study is double-blinded, which means that neither participants nor their study doctor will know which treatment arm participants are assigned to.
The study has 3 periods: Screening (4 weeks), treatment (14 weeks) and follow-up (4 weeks). Participants may be eligible to continue receiving KarXT + KarX-EC for one year in an open label treatment extension study.
During the study, participants may have the following procedures:
Physical and neurological examinations, vital signs, check of the heart rhythm, blood and urine sampling, brain magnetic resonance imaging (MRI) or Computerised Tomography (CT) Scan, PET scan (Amyloid Positron Emission Tomography) or lumbar puncture to collect cerebral spinal fluid (CSF) (if applicable).
Approximately 400 participants will take part in the study worldwide (aged 55 to 90 years) with 26 participants in the UK.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
26/YH/0094
Date of REC Opinion
9 Jun 2026
REC opinion
Further Information Favourable Opinion