Study Stopped
Study AXS-05-AD-305 was terminated due to completion of overall program objectives.
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
1 other identifier
interventional
139
2 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2024
Shorter than P25 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2024
CompletedFirst Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
December 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2025
CompletedFebruary 19, 2026
February 1, 2026
3 months
December 12, 2024
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-Term Safety
Incidence of treatment-emergent adverse events following dosing with AXS-05
Up to 25 weeks
Study Arms (1)
Open-Label
EXPERIMENTALExperimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Clinical Research Site
Peoria, Arizona, 85381, United States
Clinical Research Site
Walnut Creek, California, 94596, United States
Clinical Research Site
Bonita Springs, Florida, 34134, United States
Clinical Research Site
Brandon, Florida, 33511, United States
Clinical Research Site
Greenacres City, Florida, 33467, United States
Clinical Research Site
Hialeah, Florida, 33012, United States
Clinical Research Site
Miami, Florida, 33126, United States
Clinical Research Site
Miami, Florida, 33145, United States
Clinical Research Site
Miami, Florida, 33155, United States
Clinical Research Site
Miami, Florida, 33165, United States
Clinical Research Site
Miami, Florida, 33173, United States
Clinical Research Site
Miami Gardens, Florida, 33014, United States
Clinical Research Site
Miami Lakes, Florida, 33014, United States
Clinical Research Site
Pembroke Pines, Florida, 33025, United States
Clinical Research Site
Tampa, Florida, 33614, United States
Clinical Research Site
Tampa, Florida, 33634, United States
Clinical Research Site
Braintree, Massachusetts, 02184, United States
Clinical Research Site
Brooklyn, New York, 11229, United States
Clinical Research Site
Charlotte, North Carolina, 28211, United States
Clinical Research Site
Mesquite, Texas, 75149, United States
Clinical Research Site
Arlington, Virginia, 22205, United States
Clinical Research Site
San Juan, 00918, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2024
First Posted
December 16, 2024
Study Start
November 21, 2024
Primary Completion
February 17, 2025
Study Completion
April 25, 2025
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share