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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT06585787

Run by

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

People needed

406

Starts

2024-09-26

Expected to finish

2026-12-22

Last updated by the study team

2026-07-30

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Agile Clinical Research Trials, LLC — Atlanta, Georgia, United States (enrolling)
• Precise Research Centers — Flowood, Mississippi, United States (enrolling)
• Charter Research Orlando — Orlando, Florida, United States (enrolling)
• Premiere Research Institute at Palm Beach Neurology, PA — West Palm Beach, Florida, United States (enrolling)
• Elixia Health - Springfield - Elixia - PPDS — Springfield, Massachusetts, United States (enrolling)
• Neurobehavioral Medicine Group (NBMG) — Bloomfield Township, Michigan, United States (enrolling)
• Aqualane Clinical Research — Naples, Florida, United States (enrolling)
• Sensible HealthCare, LLC — Ocoee, Florida, United States (enrolling)
• Combined Research Orlando Phase I-IV LLC — Orlando, Florida, United States (enrolling)
• Charter Research — The Villages, Florida, United States (enrolling)
• Tufts Medical Center - 800 Washington St - PPDS — Boston, Massachusetts, United States (enrolling)
• Boston Neuro Research Center — North Dartmouth, Massachusetts, United States (enrolling)
• University of Connecticut Health Center — Farmington, Connecticut, United States (enrolling)
• Banner Alzheimer's Institute — Phoenix, Arizona, United States (enrolling)
• Envision Trials LLC — Bonita Springs, Florida, United States (enrolling)
• USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) — Los Angeles, California, United States (enrolling)
• Arrow Clinical Trials — Daytona Beach, Florida, United States (enrolling)
• Gilbert Neurology Partners - PLLC - Avacare — Gilbert, Arizona, United States (enrolling)
• Advanced Research Center, Inc. — Anaheim, California, United States (enrolling)
• Nova Psychiatry — Orlando, Florida, United States (enrolling)
• Guardian Angel Research — Tampa, Florida, United States (enrolling)
• Interventional Psychiatry of Tampa Bay — Tampa, Florida, United States (enrolling)
• Inland Psychiatric Medical Group (IPMG)-Chino — Chino, California, United States (enrolling)
• McLean Hospital — Belmont, Massachusetts, United States (enrolling)
• Tekton Research, LLC - Saint Louis Psychiatry - PPDS — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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