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AXS-05 for Alzheimer's Disease (ACCORD Trial)

Phase 3
Waitlist Available
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 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing AXS-05, a medication, to see if it can help reduce agitation in people with Alzheimer's disease by balancing brain chemicals. AXS-05 has shown potential for treating agitation in Alzheimer's disease, especially in patients with comorbid depression. Patients will first try the medication for a few weeks, and those who respond well will either continue the medication or switch to an alternative for several months.

Eligible Conditions
  • Agitated Dementia
  • Alzheimer's Disease
  • Psychomotor Agitation

Timeline

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

Treatment Details

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%
Diarrhea
7%
Somnolence
6%
Dry mouth
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
AXS-05
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AXS-05Experimental Treatment1 Intervention
Up to 26 weeks in double-blind period
Group II: PlaceboPlacebo Group1 Intervention
Up to 26 weeks in double-blind period
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
31 Previous Clinical Trials
10,749 Total Patients Enrolled
~37 spots leftby Nov 2025
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