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RECRUITING Phase 3

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

NCT05511363 · View on ClinicalTrials.gov ↗

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 and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Interventions

  • DRUG Placebo
  • DRUG KarXT

Study Locations (20)

Florida

  • Local Institution - 1011 — Boca Raton
  • Envision Trials LLC — Bonita Springs
  • Local Institution - 1015 — Bradenton
  • K2 Medical Research - Winter Garden — Clermont
  • Arrow Clinical Trials — Daytona Beach
  • Local Institution - 1045 — Doral
  • Local Institution - 1046 — Hialeah
  • Local Institution - 1024 — Hialeah
  • Local Institution - 1052 — Hialeah
  • Local Institution - 1049 — Homestead

California

  • Local Institution - 1033 — Encino
  • Local Institution - 1031 — Irvine
  • ATP Clinical Research-302 W La Veta Ave — Orange
  • Local Institution - 1043 — Pasadena
  • Local Institution - 1047 — San Marcos
  • Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS — Walnut Creek

Alabama

  • Local Institution - 1029 — Homewood

Arizona

  • Local Institution - 1044 — Phoenix

Colorado

  • Local Institution - 1014 — Colorado Springs

Connecticut

  • Local Institution - 1013 — Stamford

Trial Details

FieldValue
Enrollment Target 380 participants
Start Date 2022-08-23
Est. Completion 2026-10-05
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 NCT05511363

The ClinicalTrials.gov registry entry for NCT05511363 describes a study currently listed as 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 380 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: NCT05511363 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Alabama. 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 NCT05511363 about?

NCT05511363 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-1)". 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...

What is the current status of trial NCT05511363?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2022-08-23. Estimated completion is 2026-10-05.

What conditions does trial NCT05511363 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 NCT05511363?

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 NCT05511363?

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 NCT05511363 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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