AXS-05 for Alzheimer Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Alzheimer Disease+4 More
AXS-05 - Drug
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Agitation
  • Alzheimer Disease
  • Alzheimer's Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Alzheimer Disease

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Up to 5 weeks

Up to 5 weeks
Cohen-Mansfield Agitation Inventory (CMAI)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Alzheimer Disease

Side Effects for

AXS-05
29%All Others, occurring in <5% of Subjects
16%Dizziness
13%Nausea
8%Headache
7%Diarrhea
7%Somnolence
6%Dry mouth
1%Pancreatitis
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT04019704) in the AXS-05 ARM group. Side effects include: All Others, occurring in <5% of Subjects with 29%, Dizziness with 16%, Nausea with 13%, Headache with 8%, Diarrhea with 7%.

Trial Design

2 Treatment Groups

AXS-05
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

350 Total Participants · 2 Treatment Groups

Primary Treatment: AXS-05 · Has Placebo Group · Phase 3

AXS-05
Drug
Experimental Group · 1 Intervention: AXS-05 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXS-05
2019
Completed Phase 3
~2080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 weeks

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
6,712 Total Patients Enrolled
3 Trials studying Alzheimer Disease
886 Patients Enrolled for Alzheimer Disease

Eligibility Criteria

Age 65+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a clinical diagnosis of probable AD based on the 2011 NIA-AA criteria.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.