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Alzheimer’s disease · Drug research
The registry reports recruiting. This is trial metadata, not an assessment of treatment benefit.
Evidence 1Content updated Oct 27, 2026 · Sources last checked Oct 27, 2026
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.
This record covers only the linked trial population. This registry-based page does not review FDA approval or labeling.
FDA approval not reviewed here
Alzheimer’s disease
See FDA labeling for the approved population and indication; this page covers the trial population only.
FDA labeling has not been reviewed for this page. This does not mean the treatment is unapproved.
Approval is specific to the indication and population. It does not establish availability, reimbursement or suitability for an individual.
Enrollment status comes from the registry; check the original record for current details.
Read trial record and posted resultsStudy ages: 55 Years to 90 Years. Other eligibility criteria apply; see the full criteria above.
Study countries and territories (including sites that may be closed): Argentina, Belgium, Brazil, Bulgaria, China, Croatia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Poland, Portugal, Puerto Rico, Romania, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United States.
Sites marked recruiting: Argentina, Brazil, Bulgaria, China, France, Greece, Hungary, India, Italy, Japan, Poland, Portugal, Puerto Rico, Romania, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United States. Check the original registry record for locations and study-team contacts; overall recruiting status does not guarantee a local place.
Primary data collection: Nov 24, 2026 (estimated). This is not a results-release date.
No results-posting date in this record.
Evidence 1registry · Registry metadata is submitted by the sponsor or responsible party and does not independently validate efficacy.
No posted registry results are indicated in this source response. This does not establish that no results exist elsewhere.
Limitations: Outcomes, effect estimates, uncertainty and study quality have not been appraised. Consult original results and publications.
Evidence 1A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
registry · NCT06585787 · Structured source fields
Source date: Oct 27, 2026 · Checked: Oct 27, 2026
Evidence location: protocolSection: identificationModule, statusModule, conditionsModule, armsInterventionsModule, designModule, outcomesModule, eligibilityModule, contactsLocationsModule, sponsorCollaboratorsModule; hasResults
Status: RECRUITING. Phase: PHASE3. Conditions: Alzheimer Disease.
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