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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
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

NCT06736509

TerminatedPhase 3

Sponsor: Axsome Therapeutics, Inc.

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor

Interventions: AXS-05 (dextromethorphan-bupropion)

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 65 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Completed the treatment period in Study AXS-05-AD-304 or exited from Study AXS-05-AD-303 due to study completion.
* Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment.

Exclusion Criteria:

* Caregiver is unwilling or unable, in the opinion of the Investigator, to comply with study instructions.
* Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone.
* Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being.
* Initiation of a new medication since enrolling in AXS-05-AD-304 and/or AXS-05-AD-303 which may pose a safety risk when taken concurrently with AXS-05.
Locations (22)
  • Peoria, Arizona, United States
  • Walnut Creek, California, United States
  • Bonita Springs, Florida, United States
  • Brandon, Florida, United States
  • Greenacres City, Florida, United States
  • Hialeah, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Gardens, Florida, United States
  • Miami Lakes, Florida, United States
  • Pembroke Pines, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Braintree, Massachusetts, United States
  • Brooklyn, New York, United States
  • Charlotte, North Carolina, United States
  • Mesquite, Texas, United States
  • Arlington, Virginia, United States
  • San Juan, Puerto Rico