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An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
Sponsor: Axsome Therapeutics, Inc.
Summary
The primary objective of this open-label extension trial was to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 or ACCORD-2.
Key Details
Gender
All
Age Range
65 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
139
Start Date
2024-11-21
Completion Date
2025-04-25
Last Updated
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
AXS-05 (dextromethorphan-bupropion)
AXS-05 tablets, taken twice daily
Locations (22)
Clinical Research Site
Peoria, Arizona, United States
Clinical Research Site
Walnut Creek, California, United States
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Bonita Springs, Florida, United States
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Brandon, Florida, United States
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Greenacres City, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Miami, Florida, United States
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Miami Gardens, Florida, United States
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Miami Lakes, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Braintree, Massachusetts, United States
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Brooklyn, New York, United States
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Charlotte, North Carolina, United States
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Mesquite, Texas, United States
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Arlington, Virginia, United States
Clinical Research Site
San Juan, Puerto Rico