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X/T+ X-EC

Phase 2

Alzheimers Disease | Small molecule | Neurology |Bristol-Myers Squibb Company|Last Updated: Oct 8, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60

FDA Designations

ACCELERATED_APPROVAL

Clinical trial landscape

X/T+ X-EC · 1 trial · 1 indication

Phase 2 1
NCT07212062The Purpose of This Study is to Evaluate the Safety and Tolerability of X/T+X-EC in Participants With Alzheimer's Disease Who Are Currently Treated With Lecanemab.Alzheimers Disease
NOT YET_RECRUITING60 Analytics
PHASE2NOT YET_RECRUITING
The Purpose of This Study is to Evaluate the Safety and Tolerability of X/T+X-EC in Participants With Alzheimer's Disease Who Are Currently Treated With Lecanemab.
Alzheimers Disease
NCT0721206260
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Study Endpoints

Primary Endpoints

Assess the safety and tolerability of X/T+X-EC compared with placebo in participants with Alzheimer's Disease currently treated with Lecanemab
Baseline to week 28 as there is a 4 week follow up period after End of Treatment

Incidence of AEs/SAEs/AESIs/AEs leading to study intervention discontinuation, AEs leading to death through week 24.

Secondary Endpoints

Quality of Life in Alzheimers Disease
Three different time points from Baseline to Week 24 will be assessed.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A- Lecanemab + X/T + X-ECACTIVE_COMPARATORParticipants will receive the active drug as well as their current Lecanemab treatment.
Arm B- Lecanemab + PlaceboPLACEBO_COMPARATORParticipants will receive the non-active drug/placebo as well as their current Lecanemab treatment.

Interventions

NameTypeDescription
X/T + X-ECDRUGXanomeline and Trospium Chloride Capsules
PlaceboDRUGPlacebo
Lecanemab 10 mg/kgDRUGParticipants will continue their current Lecanemab infusions while in the study receiving the study drug or placebo.
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Eligibility Criteria

Age Range60 Years to 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria:1. Participants or their legally acceptable representative (LAR, see Appendix 1) must be able and willing to sign and date an IRB/IEC-approved written informed consent form ICF in accordance with regulatory, local, and institutional guidelines. This ICF must be obtained before per...

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