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

Karuna Therapeutics, Inc., a Bristol Myers Squibb company275 sites in 1 country500 target enrollmentAugust 28, 2023

ConditionsPsychosis Associated With Alzheimer's Disease

InterventionsKarXT Placebo

Overview

Phase: Phase 3
Intervention: KarXT
Conditions: Psychosis Associated With Alzheimer's Disease
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Enrollment: 500
Locations: 275
Primary Endpoint: Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Status: Recruiting
Last Updated: 2 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 28, 2023

End Date

December 9, 2026

Last Updated

2 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is a male or female aged 55 to 90 years, inclusive, at Screening.
•Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
•Meets clinical criteria for Possible AD or Probable AD.
•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.
•Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
•Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
•History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
•CGI-S scale with a score ≥ 4 at Screening and Baseline.
•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:
•Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR

Exclusion Criteria

•Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
•History of major depressive episode with psychotic features during the 12 months prior to Screening.
•History of bipolar disorder, schizophrenia, or schizoaffective disorder.
•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.
•History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
•Prior exposure to KarXT.
•History of hypersensitivity to KarXT excipients or trospium chloride.
•Experienced any significant adverse events (AEs) due to trospium.
•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.
•Other protocol-defined inclusion/exclusion criteria may apply.

Arms & Interventions

KarXT

Xanomeline and Trospium Chloride Capsules

Intervention: KarXT

Placebo

Placebo capsules

Intervention: Placebo

Outcomes

Primary Outcomes

Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score

Time Frame: Baseline and end of Treatment (up to 14 Weeks)

Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.

Secondary Outcomes

Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) scale(Baseline and end of Treatment (up to 14 Weeks))
Change From Baseline to end of Treatment in NPI-C Core score: Hallucinations, Delusions, Agitation, and Aggression Domains(Baseline and end of Treatment (up to 14 Weeks))
Change From Baseline to end of Treatment in NPI-C: Agitation score(Baseline and end of Treatment (up to 14 Weeks))
Change From Baseline to end of Treatment in NPI-C Core score: Caregiver Distress scale (Hallucinations, Delusions, Agitation, and Aggression domains)(Baseline and end of Treatment (up to 14 Weeks))
Responder Rate(Baseline and end of Treatment (up to 14 Weeks))