Recruiting NCT06585787

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Phase III Interventional Alzheimer 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: Alzheimer 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, Argentina, Belgium, Brazil, Bulgaria +20
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Interventions

Drug KarXT
Specified dose on specified days
Drug Placebo
Specified dose on specified days

Primary outcome measures

Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score [Time frame: Up to Week 14]

Secondary outcome measures (12)

Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale [Time frame: Up to Week 14]
Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain [Time frame: Up to Week 14]
Change from baseline in NPI-C Core score: Delusion Domain [Time frame: Up to Week 14]
Change from baseline in NPI-C Core score: Agitation Domain [Time frame: Up to Week 14]
Change from baseline in NPI-C Core score: Aggression Domain [Time frame: Up to Week 14]
Change from baseline in NPI-C Agitation score [Time frame: Up to Week 14]
Change from baseline in NPI-C Core score: Caregiver Distress Scale [Time frame: Up to Week 14]
Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score [Time frame: Up to Week 14]
Number of participants with Adverse Events (AEs) [Time frame: Up to Week 14]
Number of participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Week 14]
Number of participants with Serious Adverse Events (SAEs) [Time frame: Up to Week 14]
Number of participants with TEAEs leading to study withdrawal [Time frame: Up to Week 14]

Eligibility criteria

Inclusion criteria

Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
Patient 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, eg, major stroke, neoplasm, subdural hematoma.
Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).

Exclusion criteria

\- Patients will not be able to participate if they have:

i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.

ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.

iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.

\* Other protocol-defined Inclusion/Exclusion criteria 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