No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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
406 (estimated)
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
Who this trial is looking for
This trial is looking for adults with Alzheimer's disease who have experienced moderate to severe psychotic symptoms. Participants will receive treatment to evaluate its safety and effectiveness.
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 an MRI or CT scan of my brain in the last 5 years.
I have experienced psychotic symptoms for at least 2 months.
You may not be able to join if
My psychotic symptoms are due to something other than Alzheimer's.
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 related to my lab test results.
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 the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria
* Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
* Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
* Patient must have a magnetic resonance imaging (M…
Inclusion Criteria
* Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
* Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
* Patient 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.
* Patient 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
\- Patients will not be able to participate if they have:
i) 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.
ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
iii) Patients are not able to participate if they 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
First line of the email MUST contain NCT # and Site #.
CONTACT
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