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

NCT06585787

RecruitingPhase 3

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Conditions: Alzheimer Disease

Interventions: KarXT, Placebo

Countries: United States, Argentina, Belgium, Brazil, Bulgaria, China, Croatia, France

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 overview

Sex: ALL

Age: 55 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (292)
  • Chandler, Arizona, United States
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Anaheim, California, United States
  • Chino, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Orange, California, United States
  • Pasadena, California, United States
  • Rancho Cucamonga, California, United States
  • Farmington, Connecticut, United States
  • Atlantis, Florida, United States
  • Bonita Springs, Florida, United States
  • Cutler Bay, Florida, United States
  • Daytona Beach, Florida, United States
  • Deerfield Beach, Florida, United States
  • Doral, Florida, United States
  • Gulf Breeze, Florida, United States
  • Hialeah, Florida, United States
  • Hialeah, Florida, United States
  • Homestead, Florida, United States
  • Lady Lake, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • + 262 more on CT.gov