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

March 29, 2024 updated by: Karuna Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Buk-gu
      • Daegu, Buk-gu, Korea, Republic of, 41404
        • Recruiting
        • Clinical Trial Site
    • Dongjak-gu
      • Seoul, Dongjak-gu, Korea, Republic of, 07061
        • Recruiting
        • Clinical Trial Site
    • Gwangjin-gu
      • Seoul, Gwangjin-gu, Korea, Republic of, 05030
        • Recruiting
        • Clinical Trial Site
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • Recruiting
        • Clinical Trial Site
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Clinical Trial Site
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Recruiting
        • Clinical Trial Site
    • Namdong-gu
      • Incheon, Namdong-gu, Korea, Republic of, 21565
        • Recruiting
        • Clinical Trial Site
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85286
        • Recruiting
        • Clinical Trial Site
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Clinical Trial Site
      • Canoga Park, California, United States, 91303
        • Recruiting
        • Clinical Trial Site
      • Encino, California, United States, 91316
        • Recruiting
        • Clinical Trial Site
      • Lafayette, California, United States, 94549
        • Recruiting
        • Clinical Trial Site
      • Lancaster, California, United States, 93534
        • Recruiting
        • Clinical Trial Site
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Clinical Trial Site
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • Clinical Trial Site
    • Florida
      • Clermont, Florida, United States, 34711
        • Recruiting
        • Clinical Trial Site
      • Cutler Bay, Florida, United States, 33189
        • Recruiting
        • Clinical Trial Site
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Clinical Trial Site
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Clinical Trial Site
      • Hollywood, Florida, United States, 33020
        • Recruiting
        • Clinical Trial Site
      • Homestead, Florida, United States, 33032
        • Recruiting
        • Clinical Trial Site
      • Largo, Florida, United States, 33777
        • Recruiting
        • Clinical Trial Site
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33126
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33135
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33155
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33144
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33122
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33165
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33133
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33174
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33179
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33145
        • Recruiting
        • Clinical Trial Site
      • Miami, Florida, United States, 33175
        • Recruiting
        • Clinical Trial Site
      • Miami Gardens, Florida, United States, 33014
        • Recruiting
        • Clinical Trial Site
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Clinical Trial Site
      • Okeechobee, Florida, United States, 34972
        • Recruiting
        • Clinical Trial Site
      • Orlando, Florida, United States, 32807
        • Recruiting
        • Clinical Trial Site
      • Palmetto Bay, Florida, United States, 33157
        • Recruiting
        • Clinical Trial Site
      • Port Orange, Florida, United States, 32127
        • Recruiting
        • Clinical Trial Site
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Clinical Trial Site
      • Tampa, Florida, United States, 33629
        • Recruiting
        • Clinical Trial Site
      • Tampa, Florida, United States, 33604
        • Recruiting
        • Clinical Trial Site
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Clinical Trial Site
      • Viera, Florida, United States, 32940
        • Recruiting
        • Clinical Trial Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Clinical Trial Site
    • Illinois
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Clinical Trial Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Clinical Trial Site
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Recruiting
        • Clinical Trial Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Clinical Trial Site
    • Ohio
      • Dayton, Ohio, United States, 45459
        • Recruiting
        • Clinical Trial Site
    • Texas
      • Cypress, Texas, United States, 77429
        • Recruiting
        • Clinical Trial Site
      • Stafford, Texas, United States, 77477
        • Recruiting
        • Clinical Trial Site
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and End of Treatment (up to 14 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and End of Treatment (up to 14 weeks)
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.
Baseline and End of Treatment (up to 14 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karuna Therapeutics

Investigators

  • Study Director: Ronald Marcus, MD, Karuna Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAR-032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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