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

NCT06976203 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 586

Last updated 2026-05-20

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

KarXT

Specified dose on specified days

DRUG

KarX-EC

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-21
Primary Completion
2028-09-11
Completion
2029-02-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06976203 on ClinicalTrials.gov