CN012-0052: A Study to look at the Safety and Effectiveness of KarXT in Alzheimers' Cognition
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated with Mild to Moderate Alzheimer’s Disease (MINDSET 2)
IRAS ID
1011275
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Clinicaltrials.gov Identifier
Research summary
This study will investigate whether the study drug KarXT + KarX-EC will work to treat cognitive problems as well as improve overall function in people with Alzheimer's disease (AD). The new treatment called KarXT + KarX-EC is a combination of two different medicines. One is called xanomeline, which has shown promise in helping improve memory and thinking in people with AD in early studies. The other is called trospium, which helps reduce side effects from xanomeline that can happen outside of the brain. The study will evaluate if these medicines are effective and don't cause any serious side effects. Approximately 586 participants will take part in the study worldwide (age 60 to 85) with 32 taking part in the UK. Participants will be randomly assigned (like flipping a coin) into one of two arms: The investigational treatment arm (KarXT + KarX-EC) or the placebo arm, which is a pill that looks like the medicine but doesn't have any medicine in it. Neither the study doctor nor participant will know what treatment they have been assigned to. The study has 3 periods: Screening (5 weeks), treatment (24 weeks) and follow-up (4 weeks). If study participants complete the main portion of the study, there is a chance to enter the optional open label extension (OLE) period. Open label is when treatment assignment is known to the participant and the study doctor. In the OLE, everybody gets the active study drug. The expected duration of the study is up to 57 weeks. Participants will undergo the following assessments and tests, many of which are non-invasive: medical and neurological examinations, vital signs (like blood pressure, heart rate), ECG, blood and urine collections, brain scans (MRI) and ultrasound. Participants will need to have their AD diagnosis confirmed by either an Amyloid PET scan of the brain (Positron Emission Tomography) or by a lumbar puncture to collect cerebrospinal fluid. There are questionnaires for both the participant and their carer to complete.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0154
Date of REC Opinion
5 Sep 2025
REC opinion
Further Information Favourable Opinion