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NMDA receptor antagonist

AXS-05 for Alzheimer's Disease Agitation (ADVANCE-2 Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 weeks
Awards & highlights

ADVANCE-2 Trial Summary

This trial is studying whether a new drug, AXS-05, is effective and safe for treating people with Alzheimer's disease who have agitation.

Who is the study for?
This trial is for people with Alzheimer's disease who are experiencing significant agitation. Participants must be diagnosed based on specific criteria and able to follow the study procedures. Those with non-Alzheimer's dementia or deemed medically unfit by the investigator cannot join.Check my eligibility
What is being tested?
The trial is testing AXS-05 against a placebo to see if it can safely reduce agitation in Alzheimer's patients. It involves multiple centers, where participants are randomly assigned to receive either the real drug or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While not specified here, common side effects of drugs like AXS-05 may include nausea, headache, dizziness, and sleep disturbances. The exact side effects will be monitored throughout the trial.

ADVANCE-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohen-Mansfield Agitation Inventory (CMAI)

Side effects data

From 2019 Phase 3 trial • 327 Patients • NCT04019704
29%
All Others, occurring in <5% of Subjects
16%
Dizziness
13%
Nausea
8%
Headache
7%
Somnolence
7%
Diarrhea
6%
Dry mouth
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AXS-05

ADVANCE-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AXS-05Experimental Treatment1 Intervention
Up to 5 weeks
Group II: PlaceboPlacebo Group1 Intervention
Up to 5 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXS-05
2018
Completed Phase 3
~1390

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
28 Previous Clinical Trials
7,842 Total Patients Enrolled

Media Library

AXS-05 (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05557409 — Phase 3
Agitation in Dementia Research Study Groups: AXS-05, Placebo
Agitation in Dementia Clinical Trial 2023: AXS-05 Highlights & Side Effects. Trial Name: NCT05557409 — Phase 3
AXS-05 (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557409 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the qualifying medical condition participate in this trial at this time?

"That is correct, the public information available on clinicaltrials.gov outlines that this study is looking for more participants. The posting date was September 6th, 2022 and the most recent update was on September 23rd, 2022. In total, they need 350 individuals from 2 locations."

Answered by AI

Does this experiment only allow for volunteers that are over 40?

"The minimum age requirement to take part in this clinical trial is 65 and the maximum age is 90."

Answered by AI

How many individuals are being research in this clinical trial?

"That is correct, the clinical trial is looking for 350 patients from 2 sites. The information on clinicaltrials.gov is accurate, as the study was posted on 9/6/2022 and was last updated on 9/23/2022."

Answered by AI

Are there any specific inclusionary or exclusionary criteria for this research?

"This study, which is testing an intervention for Alzheimer's disease, is looking for 350 patients aged 65 to 90. Most importantly, potential participants must meet the following criteria: a diagnosis of probable Alzheimer's disease based on the 2011 National Institute on Aging-Alzheimer Association criteria, and a diagnosis of clinically significant agitation resulting from probable AD according to the International Psychogeriatric Association provisional definition of agitation."

Answered by AI

Could you please outline the potential risks associated with AXS-05?

"AXS-05 has undergone multiple rounds of testing with positive results, meaning it is safe to use. Our team rates it a 3 on a scale of 1 to 3."

Answered by AI

Who else is applying?

What site did they apply to?
Tandem Clinical Research - New York, NY
Clinical Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Tandem Clinical Research - Metairie, LA: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
2022. "A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05557409.
All > Alzheimers Disease Miami > Wellbutrin
~142 spots leftby Jun 2025
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