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Recruiting Phase 3 NCT06947941

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

Phase 3 – large-scale trial before approval
Conditions: Alzheimer Disease Psychosis

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Who can participate
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
KarXT
DRUG
KarX-EC
DRUG
KarXT + KarX-EC Arm Matching Placebo
DRUG
Locations 20
Australia (2)
Local Institution - 0020
Macquarie Park , New South Wales
NOT_YET_RECRUITING
Local Institution - 0052
Nedlands , Western Australia
NOT_YET_RECRUITING
Canada (2)
Local Institution - 0025
Montreal , Quebec
NOT_YET_RECRUITING
Local Institution - 0027
Whitby , Ontario
NOT_YET_RECRUITING
Japan (3)
Local Institution - 0035
Nankoku-shi
NOT_YET_RECRUITING
Local Institution - 0034
Osaka
NOT_YET_RECRUITING
Local Institution - 0040
Suita , Osaka
NOT_YET_RECRUITING
United Kingdom (8)
Local Institution - 0009
Chertsey , Surrey
NOT_YET_RECRUITING
Local Institution - 0005
Exeter , Devon
NOT_YET_RECRUITING
Local Institution - 0023
London , England
NOT_YET_RECRUITING
Local Institution - 0024
London
NOT_YET_RECRUITING
Local Institution - 0004
Motherwell
NOT_YET_RECRUITING
Local Institution - 0015
Oxford , Oxfordshire
NOT_YET_RECRUITING
Local Institution - 0018
Saint Leonards-on-Sea , East Sussex
NOT_YET_RECRUITING
Local Institution - 0017
Sheffield , Yorkshire and the Humber
NOT_YET_RECRUITING
United States (5)
Inland Psychiatric Medical Group.
Chino , California
Nandita Puchakayala, Site 0031
Local Institution - 0042
Gilbert , Arizona
NOT_YET_RECRUITING
Local Institution - 0001
Naples , Florida
WITHDRAWN
Local Institution - 1401
Naples , Florida
NOT_YET_RECRUITING
Local Institution - 0043
Shaker Heights , Ohio
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
55 Years
Maximum age
90 Years
Healthy volunteers
No
Start date
25.03.2026
Completion date
20.03.2028
Registry ID
NCT06947941
Source
clinicaltrials.gov
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