A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

Summary

The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.

Interventions

• KarXT · DRUG

  Specified dose on specified days

• KarX-EC · DRUG

  Specified dose on specified days

• KarXT + KarX-EC Arm Matching Placebo · DRUG

  Specified dose on specified days

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
* Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup.
* Participants 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.
* Participants 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:

* Participants must not have 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.
* Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
* Participants must not have certain safety concerns, including certain laboratory test irregularities.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Sites (22)

• Gilbert Neurology Partners/CCT Research, Gilbert, Arizona · RECRUITING
• Inland Psychiatric Medical Group., Chino, California · RECRUITING
• Local Institution - 0001, Naples, Florida · WITHDRAWN
• Local Institution - 1401, Naples, Florida · NOT_YET_RECRUITING
• Local Institution - 0029, Cleveland, Ohio · NOT_YET_RECRUITING
• Insight Clinical Trials LLC - Independence, Independence, Ohio · RECRUITING
• Local Institution - 0020, Macquarie Park, New South Wales, Australia · NOT_YET_RECRUITING
• Local Institution - 0052, Nedlands, Western Australia, Australia · NOT_YET_RECRUITING
• Local Institution - 0054, Toronto, Ontario, Canada · NOT_YET_RECRUITING
• Local Institution - 0027, Whitby, Ontario, Canada · NOT_YET_RECRUITING
• Local Institution - 0025, Montreal, Quebec, Canada · NOT_YET_RECRUITING
• Local Institution - 0040, Suita, Osaka, Japan · NOT_YET_RECRUITING
• Local Institution - 0035, Nankoku-shi, Japan · NOT_YET_RECRUITING
• Local Institution - 0034, Osaka, Japan · NOT_YET_RECRUITING
• Local Institution - 0005, Exeter, Devon, United Kingdom · NOT_YET_RECRUITING
• Local Institution - 0023, London, England, United Kingdom · NOT_YET_RECRUITING
• Local Institution - 0015, Oxford, Oxfordshire, United Kingdom · WITHDRAWN
• Local Institution - 0009, Chertsey, Surrey, United Kingdom · NOT_YET_RECRUITING
• Local Institution - 0017, Sheffield, Yorkshire and the Humber, United Kingdom · NOT_YET_RECRUITING
• Local Institution - 0018, Crowborough, United Kingdom · WITHDRAWN
• Local Institution - 0024, London, United Kingdom · NOT_YET_RECRUITING
• Local Institution - 0004, Motherwell, United Kingdom · NOT_YET_RECRUITING