The primary objective of this open-label extension trial is to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 and ACCORD-2.
This is a multi-center, open-label extension trial to evaluate the long-term safety of AXS-05 in subjects with Alzheimer's disease (AD) agitation that wish to continue to receive AXS-05 given completion of ADVANCE-2 (AXS-05-AD-304) and ACCORD-2 (AXS-05-AD-303).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
139
AXS-05 tablets, taken twice daily
Clinical Research Site
Peoria, Arizona, United States
Long-Term Safety
Incidence of treatment-emergent adverse events following dosing with AXS-05
Time frame: Up to 25 weeks
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