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)
Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score — Up to approximately Week 14
Trial sites (22)
Facility
City
Region
Status
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Withdrawn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.
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