The purpose of this study is to assess the safety and efficacy of KarXT in adult participants with mild to sever AD and moderate to sever psychosis related to AD.
ADEPT-4
A Phase 3, Parallel Group Study to Evaluate KarXT as Treatment for Psychosis Associated with Alzheimer's Disease.
Alzheimer's disease, Dementia
All genders
55-90
Recruiting now
Overview
Principal Investigator: Brent P. Forester, MD MSc
Contact Us
Claudia Marmelo
Study details
Inclusion Criteria
- A diagnosis of AD in accordance with the 2024 NIA-AA criteria with confirmation of AD pathology.
- Living at home or residential assisted-living facility for a minimum of 6 weeks before screening.
- History of psychotic symptoms for at least 2 months prior to screening.
Exclusion Criteria
- History of major depressive episode with psychotic features during the 12 months prior to screening
- History of bipolar disorder, schizophrenia, or schizoaffective disorder
- History of ischemic stroke within 12 mon hs prior to screening or any evidence of hemorrhagic stroke
Study Requirements
The study duration for an individual participant is approximately 22 weeks. The study includes an up to 30-Day screening period, a 2-week placebo run-in period, a 12-week randomized treatment period, and safety follow-up visit.