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A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

NCT06585787 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2026-04-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Conditions

Interventions

DRUG

KarXT

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Sponsors & Collaborators

  • Karuna Therapeutics, Inc., a Bristol Myers Squibb company

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-26
Primary Completion
2026-11-24
Completion
2026-12-22
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • China
  • Croatia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Serbia
  • Slovakia
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06585787 on ClinicalTrials.gov