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

NCT06947941

RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Alzheimer Disease, Psychosis

Interventions: KarXT, KarX-EC, KarXT + KarX-EC Arm Matching Placebo

Countries: United States, Australia, Canada, Japan, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 55 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (22)

Gilbert, Arizona, United States
Chino, California, United States
Naples, Florida, United States
Naples, Florida, United States
Cleveland, Ohio, United States
Independence, Ohio, United States
Macquarie Park, New South Wales, Australia
Nedlands, Western Australia, Australia
Toronto, Ontario, Canada
Whitby, Ontario, Canada
Montreal, Quebec, Canada
Suita, Osaka, Japan
Nankoku-shi, Japan
Osaka, Japan
Exeter, Devon, United Kingdom
London, England, United Kingdom
Oxford, Oxfordshire, United Kingdom
Chertsey, Surrey, United Kingdom
Sheffield, Yorkshire and the Humber, United Kingdom
Crowborough, United Kingdom
London, United Kingdom
Motherwell, United Kingdom