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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Alzheimer Disease, Psychosis

In brief

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

Key facts

Study ID

NCT06947941

Run by

Bristol-Myers Squibb

People needed

325

Starts

2026-03-25

Expected to finish

2028-03-20

Last updated by the study team

2026-06-30

Who can join

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

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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