NCT04947553CompletedPhase 3
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Dementia of the Alzheimer's Type
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 456 (actual)
- First submitted
- 24 Jun 2021
- Start date
- 17 Jun 2021
- Primary completion date
- 3 Dec 2024
- Lead sponsor
- Axsome Therapeutics, Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT04947553
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 456
- From 17 Jun 2021 to the primary completion date, 3 Dec 2024
- 40 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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-302 or AXS-05-AD-304 which may pose a safety risk when taken concurrently with AXS-05.
Other illness
- Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone.
Other
- Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
Who the study is looking for
- Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304.
- 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.
Age in the registry: 65 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.