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Clinical Trials in the UK / NCT06947941
Recruiting Phase 3

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

NCT06947941 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2026-03-25
Last updated
2026-06-30

Condition(s) studied

Alzheimer DiseasePsychosis

Investigational drug(s) / intervention(s)

KarXTKarX-ECKarXT + KarX-EC Arm Matching Placebo

KarXT: Specified dose on specified days

KarX-EC: Specified dose on specified days

KarXT + KarX-EC Arm Matching Placebo: Specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
55 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
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 Not Yet Recruiting
Local Institution - 0052 Nedlands Western Australia Not Yet Recruiting
Local Institution - 0054 Toronto Ontario Not Yet Recruiting
Local Institution - 0027 Whitby Ontario Not Yet Recruiting
Local Institution - 0025 Montreal Quebec Not Yet Recruiting
Local Institution - 0040 Suita Osaka 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 Not Yet Recruiting
Local Institution - 0023 London England Not Yet Recruiting
Local Institution - 0015 Oxford Oxfordshire Withdrawn
Local Institution - 0009 Chertsey Surrey Not Yet Recruiting
Local Institution - 0017 Sheffield Yorkshire and the Humber 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06947941 on ClinicalTrials.gov ↗ ← All trials in the UK