Phase 3
N=366
Addressing Dementia Via Agitation-Centered Evaluation
Agitation in Patients With Dementia of the Alzheimer's Type · Alzheimer Disease · Agitation,Psychomotor
Bottom Line
View on ClinicalTrials.gov: NCT03226522 ↗Enrolled (actual)
366
Serious AEs
4.9%
Results posted
Sep 2023
Primary outcome: Primary: Change in CMAI Total Score — -15.4; -10.0; -11.5 score on a scale — p=0.010
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AXS-05 (Drug); Bupropion (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Axsome Therapeutics, Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in CMAI Total Score |
-15.4; -10.0; -11.5 | 0.010 sig |
Summary
This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
- Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.
Exclusion Criteria
- Patient has dementia predominantly of non-Alzheimer's type.
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Data sourced from ClinicalTrials.gov (NCT03226522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.