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NCT05980949 · ClinicalTrials.gov registry record · Phase 3

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

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

Recruiting
Registry status
Phase 3
Development phase
800
Enrollment target
20
Study locations

NCT05980949 is a Phase 3 study of Psychosis Associated With Alzheimer's Disease that is actively recruiting participants, run by Karuna Therapeutics. The registered enrollment target is 800 participants, above the 363-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (120% higher). The trial reports 20 study locations across 3 states.

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The verdict

NCT05980949, a Phase 3 study of Psychosis Associated With Alzheimer's Disease, is actively recruiting participants, sponsored by Karuna Therapeutics.

RECRUITING
Registry status
Phase 3
Development phase
800 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

Conditions Studied

Psychosis Associated With Alzheimer's Disease

Interventions

  • DRUG KarXT

Study Locations (20)

California

  • Advanced Research Center, Inc. - Anaheim
  • Local Institution - 1-141NO1DG - Chino
  • Local Institution - 1001 - Costa Mesa
  • Local Institution - 1151 - Encino
  • Local Institution - 1033 - Encino
  • Local Institution - 1031 - Irvine
  • Local Institution - 1230 - Lakewood
  • Local Institution - 1142 - Lancaster
  • Local Institution - 1117 - Los Alamitos
  • USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) - Los Angeles
  • Local Institution - 1228 - Orange
  • SC3 Research - Pasadena - 960 E. Green St - Pasadena

Arizona

  • Local Institution - 1-13H98LK9 - Chandler
  • Local Institution - 1227 - Chandler
  • Local Institution - 1116 - Chandler
  • Local Institution - 1247 - Gilbert
  • Local Institution - 1217 - Phoenix
  • Local Institution - 1044 - Phoenix
  • Local Institution - 1220 - Scottsdale

Alabama

  • Local Institution - 1029 - Homewood

Trial Details

FieldValue
Enrollment Target 800 participants
Start Date 2023-07-11
Est. Completion 2027-09-07
Phase Phase 3

Sponsor

Karuna Therapeutics

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05980949

The ClinicalTrials.gov registry entry for NCT05980949 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 363-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (120% higher). 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 1 intervention - of which KarXT is the first listed.

NCT05980949 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT05980949 about?

NCT05980949 is a clinical study titled "Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)". This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will b...

What is the current status of trial NCT05980949?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2023-07-11. Estimated completion is 2027-09-07.

What conditions does trial NCT05980949 study?

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

What interventions are being tested in trial NCT05980949?

The interventions under investigation include: KarXT (DRUG).

Who is sponsoring clinical trial NCT05980949?

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

Where is trial NCT05980949 being conducted?

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

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