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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
800
KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)
Local Institution - 1029
Homewood, Alabama, United States
WITHDRAWNLocal Institution - 1-13H98LK9
Chandler, Arizona, United States
WITHDRAWNLocal Institution - 1227
Chandler, Arizona, United States
WITHDRAWNLocal Institution - 1116
Chandler, Arizona, United States
WITHDRAWNIncidence of treatment-emergent adverse events (TEAEs)
The number and percentage of participants with TEAEs will be determined
Time frame: From initial dose through 14 days after the final dose (up to 54 weeks)
Incidence of serious TEAEs
The number and percentage of participants with serious TEAEs will be determined
Time frame: From initial dose through 14 days after the final dose (up to 54 weeks)
Incidence of TEAEs leading to withdrawal
The number and percentage of participants with TEAEs leading to withdrawal will be determined
Time frame: From initial dose through 14 days after the final dose (up to 54 weeks)
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Local Institution - 1217
Phoenix, Arizona, United States
NOT_YET_RECRUITINGLocal Institution - 1044
Phoenix, Arizona, United States
WITHDRAWNLocal Institution - 1220
Scottsdale, Arizona, United States
NOT_YET_RECRUITINGAdvanced Research Center, Inc.
Anaheim, California, United States
RECRUITINGLocal Institution - 1-141NO1DG
Chino, California, United States
NOT_YET_RECRUITINGLocal Institution - 1001
Costa Mesa, California, United States
WITHDRAWN...and 401 more locations