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

RecruitingPhase 3Ages 55 Years - 90 YearsAllKaruna Therapeutics, Inc., a Bristol Myers Squibb…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • KarXT
  • Placebo
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Where

296 sites
Local Institution - 1227
Chandler, United States
Gilbert Neurology Partners - PLLC - Avacare
Gilbert, United States
Banner Alzheimer's Institute
Phoenix, United States
Local Institution - 1220
Scottsdale, United States
Advanced Research Center, Inc.
Anaheim, United States
Inland Psychiatric Medical Group (IPMG)-Chino
Chino, United States
Local Institution - 1230
Long Beach, United States
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
Los Angeles, United States

…and 288 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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