Recruiting NCT06126224

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

Phase III Interventional Psychosis Associated With Alzheimer's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: KarXT, Placebo.
Who it may be relevant to: Registry conditions: Psychosis Associated With Alzheimer's Disease. Basic parameters: 55 years — 90 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, Canada, Chile, China +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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)
Drug Placebo
Placebo capsules

Primary outcome measures

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)]

Secondary outcome measures (5)

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)]
Change From Baseline to end of Treatment in NPI-C Core score: Hallucinations, Delusions, Agitation, and Aggression Domains [Time frame: Baseline and end of Treatment (up to 14 Weeks)]
Change From Baseline to end of Treatment in NPI-C: Agitation score [Time frame: 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) [Time frame: Baseline and end of Treatment (up to 14 Weeks)]
Responder Rate [Time frame: Baseline and end of Treatment (up to 14 Weeks)]

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
Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
MMSE score of 8 to 22, inclusive, at Screening.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment