Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Public ClinicalTrials.gov record NCT04464564. 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 Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Study identification
- NCT ID
- NCT04464564
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Industry
- Enrollment
- 241 participants
Conditions and interventions
Interventions
- AVP-786 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 50 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 10, 2020
- Primary completion
- Jun 27, 2024
- Completion
- Jun 27, 2024
- Last update posted
- May 29, 2025
2020 – 2024
United States locations
- U.S. sites
- 46
- U.S. states
- 11
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Site #840-020 | Phoenix | Arizona | 85004 | — |
| Clinical Research Site #840-047 | Anaheim | California | 92805 | — |
| Clinical Research Site #840-090 | Costa Mesa | California | 92626 | — |
| Clinical Research Site #840-059 | Lafayette | California | 94549 | — |
| Clinical Research Site #840-048 | Lomita | California | 90717 | — |
| Clinical Research Site #840-095 | Long Beach | California | 90807 | — |
| Clinical Research Site #840-004 | Los Angeles | California | 90024 | — |
| Clinical Research Site #840-006 | Panorama City | California | 91402 | — |
| Clinical Research Site | San Diego | California | 92128 | — |
| Clinical Research Site #840-070 | Apopka | Florida | 32703 | — |
| Clinical Research Site #840-055 | Bradenton | Florida | 34205 | — |
| Clinical Research Site #840-096 | Cape Coral | Florida | 33904 | — |
| Clinical Research Site #840-077 | Clermont | Florida | 34771 | — |
| Clinical Research Site #840-066 | Coral Springs | Florida | 33067 | — |
| Clinical Research Site #840-039 | Hallandale | Florida | 33009 | — |
| Clinical Research Site #840-089 | Kissimmee | Florida | 34741 | — |
| Clinical Research Site #840-034 | Lady Lake | Florida | 32159 | — |
| Clinical Research Site #840-037 | Miami | Florida | 33122 | — |
| Clinical Research Site #840-092 | Miami | Florida | 33125 | — |
| Clinical Research Site #840-041 | Miami | Florida | 33126 | — |
| Clinical Research Site #840-007 | Miami | Florida | 33145 | — |
| Clinical Research Site #840-103 | Miami | Florida | 33175 | — |
| Clinical Research Site #840-042 | Miami | Florida | 33176 | — |
| Clinical Research Site #840-051 | Naples | Florida | 34105 | — |
| Clinical Research Site #840-087 | Orlando | Florida | 32807 | — |
| Clinical Research Site 840-028 | Pensacola | Florida | 32502 | — |
| Clinical Research Site # 840-105 | Tampa | Florida | 33614 | — |
| Clinical Research Site #840-104 | Tampa | Florida | 33614 | — |
| Clinical Research Site #840-049 | West Palm Beach | Florida | 33407 | — |
| Clinical Research Site #840-036 | Winter Park | Florida | 32789 | — |
| Clinical Research Site #840-065 | Atlanta | Georgia | 30318 | — |
| Clinical Research Site #840-030 | Chicago | Illinois | 60637 | — |
| Clinical Research Site #840-073 | Boston | Massachusetts | 02131 | — |
| Clinical Research Site #840-014 | Bloomfield Township | Michigan | 48302 | — |
| Clinical Research Site #840-022 | Detroit | Michigan | 48201 | — |
| Clinical Research Site #840-024 | O'Fallon | Missouri | 63368 | — |
| Clinical Research Site #840-031 | Buffalo | New York | 14030 | — |
| Clinical Research Site #840-021 | Manhasset | New York | 11030 | — |
| Clinical Research Site #840-058 | New Hyde Park | New York | 11040 | — |
| Clinical Research Site #840-035 | Cypress | Texas | 77429 | — |
| Clinical Research Site #840-053 | Dallas | Texas | 75206 | — |
| Clinical Research Site #840-093 | El Paso | Texas | 79902 | — |
| Clinical Research Site #840-072 | Houston | Texas | 77063 | — |
| Clinical Research Site #840-057 | Houston | Texas | 77077 | — |
| Clinical Research Site #840-086 | Mesquite | Texas | 75149 | — |
| Clinical Research Site #840-044 | Fairfax | Virginia | 22031 | — |
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 60 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04464564, 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 May 29, 2025 · Synced Jul 21, 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 protocol, eligibility criteria, and contact information for NCT04464564 live on ClinicalTrials.gov.