Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 – 90
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
325 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for
This trial is looking for older adults with Alzheimer's disease who have experienced psychotic symptoms. Participants will receive treatment with KarXT and KarX-EC to see how well it works and is tolerated.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 55 and 90 years old.
I have been diagnosed with Alzheimer's disease.
I have had a brain scan in the last 5 years.
I have had psychotic symptoms for at least 2 months.
You may not be able to join if
I have psychotic symptoms mainly due to another mental health condition.
I have had a major depressive episode with psychotic features in the last year.
I have a history of bipolar disorder, schizophrenia, or schizoaffective disorder.
I have certain safety concerns based on lab tests.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Trial Locations
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Status
Eligibility Criteria
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…
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.
Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
First line of the email MUST contain NCT # and Site #.
CONTACT
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