A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
Public ClinicalTrials.gov record NCT05557409. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial was a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.
Study identification
- NCT ID
- NCT05557409
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 408 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 65 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 6, 2022 (Actual)
- Primary completion
- Nov 21, 2024 (Actual)
- Completion
- Dec 21, 2024 (Actual)
- Last update posted
- Aug 13, 2026
2022 – 2024
United States locations
- U.S. sites
- 53
- U.S. states
- 16
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Site | Peoria | Arizona | 85381 | — |
| Clinical Research Site | Tempe | Arizona | 85282 | — |
| Clinical Research Site | Tucson | Arizona | 85710 | — |
| Clinical Research Site | Canoga Park | California | 91303 | — |
| Clinical Research Site | Long Beach | California | 90807 | — |
| Clinical Research Site | Los Alamitos | California | 90720 | — |
| Clinical Research Site | Walnut Creek | California | 94596 | — |
| Clinical Research Site | West Covina | California | 91790 | — |
| Clinical Research Site | Bonita Springs | Florida | 34134 | — |
| Clinical Research Site | Brandon | Florida | 33511 | — |
| Clinical Research Site | Green Acres | Florida | 33467 | — |
| Clinical Research Site | Hialeah | Florida | 33012 | — |
| Clinical Research Site | Hollywood | Florida | 33024 | — |
| Clinical Research Site | Kissimmee | Florida | 34741 | — |
| Clinical Research Site | Miami | Florida | 33126 | — |
| Clinical Research Site | Miami | Florida | 33135 | — |
| Clinical Research Site | Miami | Florida | 33145 | — |
| Clinical Research Site | Miami | Florida | 33155 | — |
| Clinical Research Site | Miami | Florida | 33165 | — |
| Clinical Research Site | Miami | Florida | 33173 | — |
| Clinical Research Site | Miami | Florida | 33175 | — |
| Clinical Research Site | Miami Gardens | Florida | 33014 | — |
| Clinical Research Site | Miami Lakes | Florida | 33014 | — |
| Clinical Research Site | Orlando | Florida | 32807 | — |
| Clinical Research Site | Pembroke Pines | Florida | 33025 | — |
| Clinical Research Site | Tampa | Florida | 33614 | — |
| Clinical Research Site | Tampa | Florida | 33634 | — |
| Clinical Research Site | Augusta | Georgia | 30912 | — |
| Clinical Research Site | College Park | Georgia | 30349 | — |
| Clinical Research Site | Columbus | Georgia | 31909 | — |
| Clinical Research Site | Wichita | Kansas | 67214 | — |
| Clinical Research Site | Marrero | Louisiana | 70072 | — |
| Clinical Research Site | Braintree | Massachusetts | 02184 | — |
| Clinical Research Site | Flint | Michigan | 48532 | — |
| Clinical Research Site | Rochester Hills | Michigan | 48307 | — |
| Clinical Research Site | Troy | Michigan | 48085 | — |
| Clinical Research Site | Chesterfield | Missouri | 63005 | — |
| Clinical Research Site | Berlin | New Jersey | 08009 | — |
| Clinical Research Site | Toms River | New Jersey | 08755 | — |
| Clinical Research Site | Brooklyn | New York | 11229 | — |
| Clinical Research Site | New Windsor | New York | 12553 | — |
| Clinical Research Site | Staten Island | New York | 10314 | — |
| Clinical Research Site | Woodmere | New York | 11598 | — |
| Clinical Research Site | Charlotte | North Carolina | 28211 | — |
| Clinical Research Site | Hickory | North Carolina | 28601 | — |
| Clinical Research Site | Middleburg Heights | Ohio | 44130 | — |
| Clinical Research Site | Austin | Texas | 78737 | — |
| Clinical Research Site | Cypress | Texas | 77429 | — |
| Clinical Research Site | Mesquite | Texas | 75149 | — |
| Clinical Research Site | San Antonio | Texas | 78229 | — |
| Clinical Research Site | Sugarland | Texas | 77478 | — |
| Clinical Research Site | Rutland | Vermont | 05701 | — |
| Clinical Research Site | Arlington | Virginia | 22205 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05557409, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2026 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05557409 live on ClinicalTrials.gov.