AXS-05 for Alzheimer's Disease Agitation
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but if you started a new medication since enrolling in the previous studies, it might be a concern if it poses a safety risk with AXS-05.
What data supports the effectiveness of the drug AXS-05 for Alzheimer's Disease Agitation?
AXS-05, a combination of dextromethorphan and bupropion, has been shown to be effective in treating major depressive disorder, with significant improvements in depression scores and high remission rates. While this data is for depression, it suggests potential benefits for Alzheimer's-related agitation due to the drug's impact on brain signaling.12345
Is AXS-05 (Dextromethorphan-Bupropion) safe for humans?
What makes the drug AXS-05 unique for treating agitation in Alzheimer's disease?
AXS-05 is unique because it combines dextromethorphan, which affects brain receptors involved in mood and behavior, with bupropion, which helps increase the effectiveness of dextromethorphan. Unlike other treatments, it is being investigated specifically for Alzheimer's-related agitation, and there are currently no FDA-approved drugs for this condition.12389
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for individuals who have Alzheimer's disease with symptoms of agitation and participated in previous ADVANCE-2 or ACCORD-2 studies. It aims to understand the long-term safety of AXS-05, a medication intended to manage these symptoms.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AXS-05 for the treatment of Alzheimer's disease agitation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- AXS-05
AXS-05 is already approved in United States for the following indications:
- Major depressive disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Axsome Therapeutics, Inc.
Lead Sponsor