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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)

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ClinicalTrials.gov Identifier: NCT06126224
Recruitment Status : Recruiting
First Posted : November 13, 2023
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Karuna Therapeutics

Study Description
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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.


Condition or disease Intervention/treatment Phase
Psychosis Associated With Alzheimer's Disease Drug: KarXT Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 26, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: KarXT
Xanomeline and Trospium Chloride Capsules
 Drug: 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 Comparator: Placebo
Placebo Capsules
 Drug: Placebo
Placebo Capsules


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from Baseline to End of Treatment in the Cohen-Mansfield Agitation Inventory (CMAI) score [ Time Frame: Baseline and End of Treatment (up to 14 weeks) ]
    Cohen-Mansfield Agitation Inventory (CMAI) is a caregiver's rating 29-item questionnaire used to assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale ranging from "1 = never" to "7 = several times per hour." Higher scores on this scale indicate worse outcomes.

  2. Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) scale [ Time Frame: Baseline and End of Treatment (up to 14 weeks) ]
    Clinical Global Impressions-Severity (CGI-S) requires the assessor to consider aspects of the psychosis (hallucinations and delusions) prior to providing a global assessment of severity. Higher scores on this scale indicate worse outcomes.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
  5. Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
  6. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
  7. CGI-S scale with a score ≥ 4 at Screening and Baseline.

  8. 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
  9. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06126224


Contacts
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Contact: Karuna Medical Information 1-888-783-0380 medinfo@karunatx.com

Locations
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Sponsors and Collaborators
Karuna Therapeutics
Investigators
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Study Director: Ronald Marcus, MD Karuna Therapeutics, Inc.
More Information
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Responsible Party: Karuna Therapeutics
ClinicalTrials.gov Identifier: NCT06126224    
Other Study ID Numbers: KAR-032
First Posted: November 13, 2023    Key Record Dates
Last Update Posted: April 30, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Psychotic Disorders
Mental Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Schizophrenia Spectrum and Other Psychotic Disorders