Status:

RECRUITING

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

Lead Sponsor:

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Conditions:

Alzheimer Disease

Eligibility:

All Genders

55-90 years

Phase:

PHASE3

Brief Summary

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.

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.

Key Trial Info

Start Date :

September 26 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 19 2026

Estimated Enrollment :

406 Patients enrolled

Trial Details

Trial ID

NCT06585787

Start Date

September 26 2024

End Date

October 19 2026

Last Update

April 1 2026

Active Locations (281)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 71 (281 locations)

1

Chandler Clinical Trials, LLC

Chandler, Arizona, United States, 85224

2

Gilbert Neurology Partners - PLLC - Avacare

Gilbert, Arizona, United States, 85297

3

Banner Alzheimer's Institute

Phoenix, Arizona, United States, 85006-2528

4

Scottsdale Clinical Trials

Scottsdale, Arizona, United States, 85260-6742

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