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ACTIVE NOT RECRUITING Phase 3

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

NCT06126224 · View on ClinicalTrials.gov ↗

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.

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

38 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06126224

The ClinicalTrials.gov registry entry for NCT06126224 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karuna Therapeutics, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06126224 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06126224?

The interventions under investigation include: Placebo (DRUG), KarXT (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06126224?

This trial is sponsored by Karuna Therapeutics, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial