Last updated 30 days ago
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
406 patients around the world
Available in Argentina, Puerto Rico, Brazil
Karuna Therapeutics
4Research sites
406Patients around the world
This study is for people with
Alzheimer disease
Requirements for the patient
To 90 Years
All Gender
Medical requirements
- Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).Patients who are diagnosed with possible AD or probable AD.Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain 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.Patient must have a history of psychotic symptoms for at least 2 months prior to Screening (Visit 1).Other protocol-defined criteria apply.
- Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.Other protocol-defined criteria apply.
Sites
Santa Cruz Behavioral PSC - Puerto Rico
Recruiting
CDT Grupo Médico San Pablo Inc. - Puerto Rico
Recruiting
Instituto De Neurología Dra. Ivonne Fraga - Puerto Rico
Recruiting
Barbara Diaz Hernandez MD Research Inc. - Puerto Rico
Recruiting
StudyADEPT-4
SponsorKaruna Therapeutics
Study typeInterventional
Conditions
Alzheimer disease
Requirements
To 90 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06585787
