drugset / Trial / NCT05980949
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.
Timeline
- Start
- 2023-07-11
- Primary completion
- 2027-09-07
- Completion
- 2027-09-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trospium | Small molecule | 2 mg | — |
| Subject | Trospium | Small molecule | 3 mg | — |
| Subject | Trospium | Small molecule | 4 mg | — |
| Subject | Trospium | Small molecule | 5 mg | — |
| Subject | Trospium | Small molecule | 6.67 mg | — |
| Subject | Xanomeline | Small molecule | 20 mg | — |
| Subject | Xanomeline | Small molecule | 30 mg | — |
| Subject | Xanomeline | Small molecule | 40 mg | — |
| Subject | Xanomeline | Small molecule | 50 mg | — |
| Subject | Xanomeline | Small molecule | 66.7 mg | — |