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NCT06126224 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

A Phase 3 study of Psychosis Associated With Alzheimer's Disease, sponsored by Karuna Therapeutics.

Active
Registry status
Phase 3
Development phase
400
Enrollment target
20
Study locations

NCT06126224 is a Phase 3 study of Psychosis Associated With Alzheimer's Disease that is active but no longer recruiting, run by Karuna Therapeutics. The registered enrollment target is 400 participants, below the 463-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT06126224, a Phase 3 study of Psychosis Associated With Alzheimer's Disease, is active but no longer recruiting, sponsored by Karuna Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
400 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

Conditions Studied

Psychosis Associated With Alzheimer's Disease

Interventions

  • DRUG Placebo
  • DRUG KarXT

Study Locations (20)

Florida

  • Local Institution - 1156 - Clermont
  • Local Institution - 1138 - Cutler Bay
  • Local Institution - 1162 - Delray Beach
  • Local Institution - 1164 - Doral
  • Local Institution - 1165 - Fort Myers
  • Local Institution - 1155 - Hialeah
  • Local Institution - 1107 - Hialeah
  • Local Institution - 1120 - Hialeah
  • Local Institution - 1140 - Hialeah
  • Local Institution - 0150 - Homestead
  • Local Institution - 1145 - Homestead

California

  • Local Institution - 1104 - Anaheim
  • Local Institution - 1119 - Canoga Park
  • Local Institution - 1151 - Encino
  • Local Institution - 1142 - Lancaster
  • Local Institution - 1117 - Los Alamitos
  • Local Institution - 1103 - Sherman Oaks
  • Local Institution - 1007 - Walnut Creek

Arizona

  • Local Institution - 1116 - Chandler
  • Local Institution - 1044 - Phoenix

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2023-08-28
Est. Completion 2025-07-31
Phase Phase 3

Sponsor

Karuna Therapeutics

11 total trials

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What the Registry Record Tells You About NCT06126224

The ClinicalTrials.gov registry entry for NCT06126224 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 463-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (14% lower). The listed sponsor is Karuna Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Psychosis Associated With Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06126224 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT06126224 about?

NCT06126224 is a clinical study titled "A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)". This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary ob...

What is the current status of trial NCT06126224?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2023-08-28. Estimated completion is 2025-07-31.

What conditions does trial NCT06126224 study?

This clinical trial studies the following conditions: Psychosis Associated With Alzheimer's Disease.

What interventions are being tested in trial NCT06126224?

The interventions under investigation include: Placebo (DRUG), KarXT (DRUG).

Who is sponsoring clinical trial NCT06126224?

This trial is sponsored by Karuna Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06126224 being conducted?

This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.