Assessing Clinical Outcomes in Alzheimer's Disease Agitation
Public ClinicalTrials.gov record NCT04797715. 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
A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.
Study identification
- NCT ID
- NCT04797715
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 178 participants
Conditions and interventions
Conditions
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
- Dec 31, 2020 (Actual)
- Primary completion
- Nov 21, 2022 (Actual)
- Completion
- Nov 21, 2022 (Actual)
- Last update posted
- Nov 29, 2023
2020 – 2022
United States locations
- U.S. sites
- 61
- U.S. states
- 22
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Site | Sun City | Arizona | 85351 | — |
| Clinical Research Site | Tucson | Arizona | 85710 | — |
| Clinical Research Site | Chula Vista | California | 91910 | — |
| Clinical Research Site | Imperial | California | 92251 | — |
| Clinical Research Site | Lafayette | California | 94549 | — |
| Clinical Research Site | Los Alamitos | California | 90720 | — |
| Clinical Research Site | Los Angeles | California | 90064 | — |
| Clinical Research Site | Oceanside | California | 92056 | — |
| Clinical Research Site | San Diego | California | 92103 | — |
| Clinical Research Site | Santa Ana | California | 92705 | — |
| Clinical Research Site | Temecula | California | 92591 | — |
| Clinical Research Site | Coral Springs | Florida | 33067 | — |
| Clinical Research Site | Hialeah | Florida | 33012 | — |
| Clinical Research Site | Kissimmee | Florida | 34741 | — |
| Clinical Research Site | Lake City | Florida | 32055 | — |
| Clinical Research Site | Miami | Florida | 33155 | — |
| Clinical Research Site | Miami | Florida | 33175 | — |
| Clinical Research Site | Miami | Florida | 48532 | — |
| Clinical Research Site | Miami Lakes | Florida | 33014 | — |
| Clinical Research Site | Naples | Florida | 34105 | — |
| Clinical Research Site | Ocoee | Florida | 34761 | — |
| Clinical Research Site | Orlando | Florida | 32807 | — |
| Clinical Research Site | Orlando | Florida | 32819 | — |
| Clinical Research Site | Pembroke Pines | Florida | 33024 | — |
| Clinical Research Site | Pensacola | Florida | 32502 | — |
| Clinical Research Site | St. Petersburg | Florida | 33709 | — |
| Clinical Research Site | Sunrise | Florida | 33351 | — |
| Clinical Research Site | Tampa | Florida | 33634 | — |
| Clinical Research Site | Trinity | Florida | 34655 | — |
| Clinical Research Site | Augusta | Georgia | 30912 | — |
| Clinical Research Site | Columbus | Georgia | 31909 | — |
| Clinical Research Site | Suwanee | Georgia | 30024 | — |
| Clinical Research Site | Honolulu | Hawaii | 92103 | — |
| Clinical Research Site | Boise | Idaho | 83704 | — |
| Clinical Research Site | Wichita | Kansas | 67214 | — |
| Clinical Research Site | Bangor | Maine | 04401 | — |
| Clinical Research Site | Lowell | Massachusetts | 01852 | — |
| Clinical Research Site | Flint | Michigan | 48532 | — |
| Clinical Research Site | Chesterfield | Missouri | 63005 | — |
| Clinical Research Site | Las Vegas | Nevada | 89106 | — |
| Clinical Research Site | Toms River | New Jersey | 08755 | — |
| Clinical Research Site | Brooklyn | New York | 11229 | — |
| Clinical Research Site | East Syracuse | New York | 13057 | — |
| Clinical Research Site | New Windsor | New York | 12553 | — |
| Clinical Research Site | New York | New York | 10036 | — |
| Clinical Research Site | Charlotte | North Carolina | 28211 | — |
| Clinical Research Site | Hickory | North Carolina | 28601 | — |
| Clinical Research Site | Dayton | Ohio | 45459 | — |
| Clinical Research Site | Jenkintown | Pennsylvania | 19046 | — |
| Clinical Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Clinical Research Site | Austin | Texas | 78737 | — |
| Clinical Research Site | Cypress | Texas | 77429 | — |
| Clinical Research Site | Houston | Texas | 77074 | — |
| Clinical Research Site | McKinney | Texas | 75071 | — |
| Clinical Research Site | Mesquite | Texas | 75149 | — |
| Clinical Research Site | San Antonio | Texas | 78229 | — |
| Clinical Research Site | Sugar Land | Texas | 77479 | — |
| Clinical Research Site | West Jordan | Utah | 84088 | — |
| Clinical Research Site | Woodstock | Vermont | 05091 | — |
| Clinical Research Site | Everett | Washington | 98201 | — |
| Clinical Research Site | Waukesha | Wisconsin | 53188 | — |
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 NCT04797715, 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 Nov 29, 2023 · 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 NCT04797715 live on ClinicalTrials.gov.