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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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520747-32-00
Acronym
CN012-0052
Enrollment
292
Registered
2025-10-21
Start date
2025-10-29
Completion date
Unknown
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate Alzheimer’s Disease

Brief summary

Change from baseline in ADAS-Cog11 at Week 24, CIBIC+ at Week 24

Detailed description

Change from baseline in ADCS-ADL at Week 24, Change from baseline in NPI total score at Week 24, Occurence of AEs and SAEs, AESIs, AEs leading to study intervention discontinuation, AEs leading to study discontinuation, and AEs leading to death through Week 24, Incidence and severity of clinically significant changes in vital signs, ECG, C-SSRS, weight, and safety laboratory tests through Week 24

Interventions

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in ADAS-Cog11 at Week 24, CIBIC+ at Week 24

Secondary

MeasureTime frame
Change from baseline in ADCS-ADL at Week 24, Change from baseline in NPI total score at Week 24, Occurence of AEs and SAEs, AESIs, AEs leading to study intervention discontinuation, AEs leading to study discontinuation, and AEs leading to death through Week 24, Incidence and severity of clinically significant changes in vital signs, ECG, C-SSRS, weight, and safety laboratory tests through Week 24

Countries

Finland, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026