AXS-05 for Alzheimer Disease
Phase-Based Progress Estimates
Effectiveness
Safety
Alzheimer Disease+4 More
AXS-05 - DrugEligibility
65+
All Sexes
What conditions do you have?
Select
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
This is further along than 85% of similar trials
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
This is further along than 85% of similar trials
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
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: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
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 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.
Popular Clinical Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments