Recruiting

Trial ID CN012-0034 | NCT06947941

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

Summary

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

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).

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.

Additional Information *

Study Arms

Experimental: KarXT + KarX-EC Arm

ASSIGNED INTERVENTION

Study Arms

Placebo Comparator: Placebo

ASSIGNED INTERVENTION

Take the first step to see if you Match to a Clinical Trial – Check if you qualify

Check if you qualify

Answer some questions about Your health to see if you may match to this trial

Match to a Trial

If you are a match, click on the study to see the list of study site locations

Select a Study Site Location

Select a study site location that is convenient for you

Provide your contact details for the study site to connect with you.