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Clinical Trials in China / NCT06126224
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 · tracked via the Priya Life Science China tracker
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Phase
Phase 3
Started
2023-08-28
Last updated
2026-09-04

Condition(s) studied

Psychosis Associated With Alzheimer's Disease

Investigational drug(s) / intervention(s)

KarXTPlacebo

KarXT: KarXT 20/2 mg (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg (TDD 90/9 mg) KarXT 40/4 mg (TDD 120/12 mg) KarXT 50/5 mg (TDD 150/15 mg) KarXT 66.7/6.67 mg (TDD 200/20 mg)

Placebo: Placebo capsules

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (154)

FacilityCityRegionStatus
Local Institution - 1116 Chandler Arizona Active Not Recruiting
Local Institution - 1044 Phoenix Arizona Active Not Recruiting
Local Institution - 1104 Anaheim California Active Not Recruiting
Local Institution - 1119 Canoga Park California Active Not Recruiting
Local Institution - 1151 Encino California Active Not Recruiting
Local Institution - 1142 Lancaster California Active Not Recruiting
Local Institution - 1117 Los Alamitos California Active Not Recruiting
Local Institution - 1103 Sherman Oaks California Active Not Recruiting
Local Institution - 1007 Walnut Creek California Active Not Recruiting
Local Institution - 1160 Apopka Florida Withdrawn
Local Institution - 1156 Clermont Florida Active Not Recruiting
Local Institution - 1138 Cutler Bay Florida Active Not Recruiting
Local Institution - 1162 Delray Beach Florida Active Not Recruiting
Local Institution - 1164 Doral Florida Active Not Recruiting
Local Institution - 1165 Fort Myers Florida Active Not Recruiting
Local Institution - 1155 Hialeah Florida Active Not Recruiting
Local Institution - 1107 Hialeah Florida Active Not Recruiting
Local Institution - 1120 Hialeah Florida Active Not Recruiting
Local Institution - 1140 Hialeah Florida Active Not Recruiting
Local Institution - 0150 Homestead Florida Active Not Recruiting
Local Institution - 1145 Homestead Florida Active Not Recruiting
Local Institution - 1127 Largo Florida Active Not Recruiting
Local Institution - 1039 Maitland Florida Active Not Recruiting
Local Institution - 1146 Maitland Florida Active Not Recruiting
Local Institution - 1159 Miami Florida Active Not Recruiting
Local Institution - 1118 Miami Florida Active Not Recruiting
Local Institution - 1111 Miami Florida Active Not Recruiting
Local Institution - 1108 Miami Florida Active Not Recruiting
Local Institution - 1125 Miami Florida Active Not Recruiting
Local Institution - 1115 Miami Florida Active Not Recruiting
Local Institution - 1143 Miami Florida Active Not Recruiting
Local Institution - 1113 Miami Florida Active Not Recruiting
Local Institution - 1009 Miami Florida Active Not Recruiting
Local Institution - 1129 Miami Florida Active Not Recruiting
Local Institution - 1150 Miami Florida Active Not Recruiting
Local Institution - 1109 Miami Florida Active Not Recruiting
Local Institution - 1158 Miami Florida Active Not Recruiting
Local Institution - 1147 Miami Florida Active Not Recruiting
Local Institution - 1105 Miami Florida Active Not Recruiting
Local Institution - 1157 Miami Florida Active Not Recruiting

+ 114 more sites — see the full list on the official registry below.

More Karuna Therapeutics, Inc., a Bristol Myers Squibb company trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06126224 on ClinicalTrials.gov ↗ ← All trials in China