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
Reason given: Study AXS-05-AD-305 was terminated due to completion of overall program objectives.
Key facts
- Where
- Arlington, Bonita Springs, Braintree, Brandon, Brooklyn, Charlotte, Greenacres City, Hialeah, Mesquite, Miami, Miami Gardens, Miami Lakes, Pembroke Pines, Peoria, Tampa, and Walnut Creek, United StatesSee the 16 sites
- Phase
- Phase 3
Where in United States
- ArlingtonArlington, United StatesNo longer taking part
- Bonita SpringsBonita Springs, United StatesNo longer taking part
- BraintreeBraintree, United StatesNo longer taking part
- BrandonBrandon, United StatesNo longer taking part
- BrooklynBrooklyn, United StatesNo longer taking part
- CharlotteCharlotte, United StatesNo longer taking part
- Greenacres CityGreenacres City, United StatesNo longer taking part
- HialeahHialeah, United StatesNo longer taking part
- MesquiteMesquite, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- Miami GardensMiami Gardens, United StatesNo longer taking part
- Miami LakesMiami Lakes, United StatesNo longer taking part
- Pembroke PinesPembroke Pines, United StatesNo longer taking part
- PeoriaPeoria, United StatesNo longer taking part
- TampaTampa, United StatesNo longer taking part
- Walnut CreekWalnut Creek, United StatesNo longer taking part
Trial details
- Who runs it
- Axsome Therapeutics, Inc.
- Trial code
- NCT06736509
- Record updated
- 25 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone; Caregiver is unwilling or unable, in the opinion of the Investigator, to comply with study instructions.