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NCT06947941PHASE3Recruiting

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

Bristol-Myers Squibb

Start Date

3/25/2026

Completion Date

3/20/2028

Summary

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

Eligibility Criteria

Age Range: 55 years to 90 years

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.

Interventions

DRUG

KarXT

DRUG

KarX-EC

DRUG

KarXT + KarX-EC Arm Matching Placebo

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Conditions

Alzheimer DiseasePsychosis

Locations

Gilbert Neurology Partners/CCT Research

Gilbert, Arizona 85297

United States

Inland Psychiatric Medical Group.

Chino, California 91710

United States

Local Institution - 0001

Naples, Florida 34105

United States

Local Institution - 1401

Naples, Florida 34105

United States

Local Institution - 0029

Cleveland, Ohio 44195

United States

Insight Clinical Trials LLC - Independence

Independence, Ohio 44131

United States

Local Institution - 0020

Macquarie Park, New South Wales 2113

Australia

Local Institution - 0052

Nedlands, Western Australia 6009

Australia

Local Institution - 0054

Toronto, Ontario M6J1H4

Canada

Local Institution - 0027

Whitby, Ontario L1N 5S9

Canada

Local Institution - 0025

Montreal, Quebec H4H 1R3

Canada

Local Institution - 0040

Suita, Osaka 565-0871

Japan

Local Institution - 0035

Nankoku-shi, 783-8505

Japan

Local Institution - 0034

Osaka, 550-0006

Japan

Local Institution - 0005

Exeter, Devon EX12LU

United Kingdom

Local Institution - 0023

London, England W1G 8TA

United Kingdom

Local Institution - 0015

Oxford, Oxfordshire OX3 7JX

United Kingdom

Local Institution - 0009

Chertsey, Surrey KT160PZ

United Kingdom

Local Institution - 0017

Sheffield, Yorkshire and the Humber S47QQ

United Kingdom

Local Institution - 0018

Crowborough, TN6 1NY

United Kingdom

Local Institution - 0024

London, WC1N3BG

United Kingdom

Local Institution - 0004

Motherwell, ML1 4UF

United Kingdom