A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

Phase 3

Not yet recruiting

• Conditions: Alzheimer's Disease
• Interventions: Drug: KarXT; Other: Placebo; Drug: KarX-EC

• Registration Number: NCT06976203
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Study First Posted: 2025-05-16
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-15
• Study Start: 2025-07-25
• Primary Completion: 2028-09-11
• Study Completion: 2029-02-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 586

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KarXT + KarX-EC	KarXT	-
KarXT + KarX-EC	KarX-EC	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)	At week 24
Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)	At week 24

Secondary Outcome Measures

Name	Time	Method
Number of participants with clinically significant changes in electrocardiogram (ECG) tests	At week 24
Number of participants with AEs leading to study discontinuation	At week 24
Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests	At week 24
Number of participants with clinically significant changes in safety laboratory tests	At week 24
Number of participants with serious adverse events (SAEs)	At week 24
Number of participants with adverse events (AEs)	At week 24
Number of participants with adverse event of special interest (AESIs)	At week 24
Number of participants with AEs leading to death	At week 24
Change from baseline in neuro psychiatric inventory (NPI) total score	At week 24
Number of participants with AEs leading to study intervention discontinuation	At week 24
Number of participants with clinically significant changes in vital signs	At week 24
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL)	At week 24
Number of participants with clinically significant changes in weight	At week 24

Trial Locations

Locations (116)

Local Institution - 0072; 🇺🇸 Fullerton, California, United States

Local Institution - 0091; 🇺🇸 Inglewood, California, United States

Local Institution - 0095; 🇺🇸 Irvine, California, United States

Local Institution - 0083; 🇺🇸 Palo Alto, California, United States

Local Institution - 0069; 🇺🇸 San Diego, California, United States

Local Institution - 0088; 🇺🇸 Denver, Colorado, United States

Local Institution - 0090; 🇺🇸 Fort Myers, Florida, United States

Local Institution - 0086; 🇺🇸 Hallandale Beach, Florida, United States

Local Institution - 0092; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0082; 🇺🇸 Sarasota, Florida, United States

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