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A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

NCT05511363 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2026-05-04

No results posted yet for this study

Summary

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease.

The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Conditions

  • Psychosis Associated With Alzheimer's Disease

Interventions

DRUG

KarXT

KarXT 20 mg/2 mg TID KarXT 30 mg/3 mg TID KarXT 40 mg/4 mg TID KarXT 50 mg/5 mg TID KarXT 66.7/6.67 mg TID

DRUG

Placebo

Placebo Capsules

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
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2026-10-05
Completion
2026-10-05
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Croatia
  • Czechia
  • France
  • Germany
  • Italy
  • Serbia
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT05511363 on ClinicalTrials.gov