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

NCT ID: NCT06126224
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions: Psychosis Associated With Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

Enrollment: 500 participants (Estimated).

What is being studied

Drug: KarXT
Drug: Placebo

Who may be eligible

Ages: 55 Years to 90 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Key Inclusion Criteria: 1. Is a male or female aged 55 to 90 years, inclusive, at Screening. 2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed. 3. Meets clinical criteria for Possible AD or Probable AD. 4. Must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening. 5. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening. 6. Have an identified study partner who should have daily contact (approximately 10 hours a week or more). 7. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening. 8. CGI-S scale with a score ≥ 4 at Screening and Baseline. 9. AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline: 1. Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR 2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items 10. MMSE score of 8 to 22, inclusive, at Screening. Key Exclusion Criteria: 1. Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia. 2. History of major depressive episode with psychotic features during the 12 months prior to Screening. 3. History of bipolar disorder, schizophrenia, or schizoaffective disorder. 4. Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results. 5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator. 6. Prior exposure to KarXT. 7. History of hypersensitivity to KarXT excipients or trospium chloride. 8. Experienced any significant adverse events (AEs) due to trospium. 9. Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the 12 months prior to Screening. 10. Other protocol-defined inclusion/exclusion criteria may apply.

Study locations

157 study locations are listed.

Recruiting site status is explicitly provided for 157 locations; 7 are listed as Recruiting.

Countries: Belgium, Canada, Chile, China, Greece, Hungary, Mexico, Peru, Poland, South Korea, Switzerland, Turkey (Türkiye), United Kingdom, United States

Limburg, Belgium: 1
Vlaams Brabant, Belgium: 1
West-Vlaanderen, Belgium: 1
Alberta, Canada: 1
Ontario, Canada: 3
Quebec, Canada: 2
Santiago Metropolitan, Chile: 2
Anhui, China: 1
Beijing Municipality, China: 3
Chongqing Municipality, China: 1
Guangdong, China: 4
Jiangsu, China: 2
Jiangxi, China: 1
Shanghai Municipality, China: 2
Sichuan, China: 2
Tianjin Municipality, China: 1
Zhejiang, China: 5
Attica, Greece: 4
Baranya, Hungary: 1
Coahuila, Mexico: 1
Estado de Baja California, Mexico: 1
Jalisco, Mexico: 1
Nuevo León, Mexico: 2
Sinaloa, Mexico: 1
Lima region, Peru: 2
Lódzkie, Poland: 1
Lublin Voivodeship, Poland: 1
Pomeranian Voivodeship, Poland: 1
Silesian Voivodeship, Poland: 1
Daegu Gwang'yeogsi, South Korea: 1

Sample of listed locations

Biomedica Research Group — Providencia, Santiago Metropolitan, 7500000, Chile — Recruiting
Psicomed Estudios Medicos — Antofagasta, 1270244, Chile — Recruiting
Local Institution - 6001 — Las Condes, 7550000, Chile — Recruiting
Shanghai General Hospital - North Campus — Shanghai, Shanghai Municipality, 200080, China — Recruiting
Health Synergy Clinical Research,LLC - Stuart — Stuart, Florida, 34994, United States — Recruiting
Local Institution - 1131 — Viera, Florida, 32940, United States — Recruiting
Local Institution - 1106 — Cypress, Texas, 77429-6070, United States — Recruiting
Local Institution - 2801 — Hasselt, Limburg, 3500, Belgium — Active, not recruiting
Local Institution - 2802 — Leuven, Vlaams Brabant, 3000, Belgium — Active, not recruiting
Local Institution - 2803 — Roeselare, West-Vlaanderen, 8800, Belgium — Active, not recruiting
Local Institution - 1605 — Calgary, Alberta, T2N 1N4, Canada — Withdrawn
Local Institution - 1603 — Hamilton, Ontario, ON L8M 1W9, Canada — Withdrawn
Local Institution - 1602 — Toronto, Ontario, M5B 1W8, Canada — Withdrawn
Local Institution - 1604 — Whitby, Ontario, L1N 5S9, Canada — Withdrawn
Local Institution - 1606 — Montreal, Quebec, H4H 1R3, Canada — Withdrawn
Local Institution - 1601 — Verdun, Quebec, H4H 1R3, Canada — Withdrawn
Local Institution - 6005 — Las Condes, Santiago Metropolitan, 7550000, Chile — Not yet recruiting
Local Institution - 7007 — Hefei, Anhui, 230022, China — Active, not recruiting
Local Institution - 7004 — Beijing, Beijing Municipality, 100025, China — Completed
Local Institution - 7005 — Beijing, Beijing Municipality, 100088, China — Active, not recruiting
Local Institution - 7045 — Beijing, Beijing Municipality, 100070, China — Not yet recruiting
Local Institution - 7015 — Chongqing, Chongqing Municipality, 400016, China — Active, not recruiting
Local Institution - 7008 — Guangzhou, Guangdong, 0, China — Completed
Local Institution - 7009 — Guangzhou, Guangdong, 510260, China — Active, not recruiting
Local Institution - 7016 — Guangzhou, Guangdong, 510120, China — Active, not recruiting

Study details

Start date: August 28, 2023
Primary completion date: December 9, 2026
Completion date: December 9, 2026
First posted: November 13, 2023

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06126224
Registry last updated: October 16, 2026
QualifiedStudies registry data refreshed: October 19, 2026
QualifiedStudies record fetched: October 19, 2026

View NCT06126224 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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