At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 366 enrolled
Drug / intervention
AXS-05 +2 moredrug
Likely dose
Not stated in record
Key inclusion· 2
- ✓Diagnosis of probable Alzheimer's disease based on 2011 NIA-AA criteria
- ✓Clinically significant agitation resulting from probable AD per IPA provisional definition
Key exclusion· 3
- ✕Dementia predominantly of non-Alzheimer's type
- ✕Unable to comply with study procedures
- ✕Medically inappropriate for study participation per investigator judgment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type
In Brief
A Phase 3 clinical trial evaluating AXS-05, Bupropion, and 1 other intervention for Agitation in Patients With Dementia of the Alzheimer's Type and 2 related conditions. Completed, enrolled 366 participants across 78 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAgitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
CountriesAustralia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJul 2017
First PostedJul 2017
Primary CompletionApr 2020
TodayJul 2026
First PostedJul 21, 2017
Enrollment StartJul 13, 2017
Primary CompletionApr 17, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.9 years ago
Interventions
AXS-05drug
AXS-05
Bupropiondrug
Bupropion
Placebodrug
Placebo