Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT ID: NCT04408755
Last Updated: 2025-05-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
184 participants
INTERVENTIONAL
2020-07-13
2024-06-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT04464564
Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT02442765
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
NCT02442778
Assessment of 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
NCT03393520
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT02446132
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This was a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Screening occurred within 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were randomized into the study.
184 participants were enrolled into the study.
Study medication was administered orally twice daily from Day 1 through Day 85.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786 matching placebo capsules, twice a day, for 11 weeks in Period B.
Placebo
oral capsules
AVP-786-18
Participants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786-18 (d6-DM 18 milligrams (mg)/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.
AVP-786
oral capsules
AVP-786-42.63
Participants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.
AVP-786
oral capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AVP-786
oral capsules
Placebo
oral capsules
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
* Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
* Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
* Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff
* Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the participant
Exclusion Criteria
* Participants with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium)
* Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy \[except skin basal-cell carcinoma\], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
* Participants with myasthenia gravis
50 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Research Site #840-081
Fort Smith, Arkansas, United States
Clinical Research Site #840-035
La Jolla, California, United States
Clinical Research Site #840-084
Los Angeles, California, United States
Clinical Research Site #840-050
Oceanside, California, United States
Clinical Research Site #840-064
Pasadena, California, United States
Clinical Research Site #840-098
Santa Ana, California, United States
Clinical Research Site #840-090
Basalt, Colorado, United States
Clinical Research Site #840-009
Atlantis, Florida, United States
Clinical Research Site #840-056
Brandon, Florida, United States
Clinical Research Site #840-020
Coral Gables, Florida, United States
Clinical Research Site #840-059
Doral, Florida, United States
Clinical Research Site #840-131
Hialeah, Florida, United States
Clinical Research Site #840-039
Jacksonville, Florida, United States
Clinical Research Site #840-012
Kissimmee, Florida, United States
Clinical Research Site #840-069
Maitland, Florida, United States
Clinical Research Site #840-083
Maitland, Florida, United States
Clinical Research Site #840-118
Miami, Florida, United States
Clinical Research Site #840-004
Miami, Florida, United States
Clinical Research Site #840-125
Miami, Florida, United States
Clinical Research Site #840-104
Miami, Florida, United States
Clinical Research Site #840-133
Miami, Florida, United States
Clinical Research Site #840-042
Miami, Florida, United States
Clinical Research Site #840-003
Miami, Florida, United States
Clinical Research Site #840-036
Orlando, Florida, United States
Clinical Research Site 840-111
Pembroke Pines, Florida, United States
Clinical Research Site #840-096
Pensacola, Florida, United States
Clinical Research Site
Pompano Beach, Florida, United States
Clinical Research Site #840-079
Tampa, Florida, United States
Clinical Research Site #840-112
Tampa, Florida, United States
Clinical Research Site #840-046
Tampa, Florida, United States
Clinical Research Site #840-107
West Palm Beach, Florida, United States
Clinical Research Site #840-049
Glen Burnie, Maryland, United States
Clinical Research Site #840-093
Rochester Hills, Michigan, United States
Clinical Research Site #840-015
Hattiesburg, Mississippi, United States
Clinical Research Site #840-029
West Long Branch, New Jersey, United States
Clinical Research Site #840-072
New Windsor, New York, United States
Clinical Research Site #840-097
The Bronx, New York, United States
Clinical Research Site #840-095
Monroe, North Carolina, United States
Clinical Research Site #840-060
Canton, Ohio, United States
Clinical Research Site #840-028
Columbus, Ohio, United States
Clinical Research Site #840-061
Edmond, Oklahoma, United States
Clinical Research Site #840-099
Tulsa, Oklahoma, United States
Clinical Research Site #840-115
McKinney, Texas, United States
Clinical Research Site
The Woodlands, Texas, United States
Clinical Research Site #840-025
Richmond, Virginia, United States
Clinical Research Site #100-115
Pernik, , Bulgaria
Clinical Research Site #100-112
Pleven, , Bulgaria
Clinical Research Site #100-106
Plovdiv, , Bulgaria
Clinical Research Site #100-102
Sofia, , Bulgaria
Clinical Research Site #100-111
Sofia, , Bulgaria
Clinical Research Site #100-105
Varna, , Bulgaria
Clinical Research Site #100-108
Varna, , Bulgaria
Clinical Research Site #100-113
Veliko Tarnovo, , Bulgaria
Clinical Research Site # 208-001
Aalborg, North Denmark, Denmark
Clinical Research Site #208-002
Aalborg, , Denmark
Clinical Research Site #1 Site #233-002
Tallinn, , Estonia
Clinical Research Site #2 Site #233-004
Tallinn, , Estonia
Clinical Research Site #233-001
Tartu, , Estonia
Clinical Research Site #276-017
Böblingen, Baden-Wurttemberg, Germany
Clinical Research Site #276-005
Bad Homburg, Hesse, Germany
Clinical Research Site #276-012
Gera, Thuringia, Germany
Clinical Research Site 276-014
Berlin, , Germany
Clinical Research Site# 300-005
Athens, , Greece
Clinical Research Site #300-006
Ioannina, , Greece
Clinical Research Site #300-003
Thessaloniki, , Greece
Clinical Research Site #616-018
Zabrze, Katowice, Poland
Clinical Research Site #616-009
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Clinical Research Site #616-006
Lublin, Lublin Voivodeship, Poland
Clinical Research Site #616-015
Sochaczew, Masovian Voivodeship, Poland
Clinical Research Site #616-013
Bydgoszcz, , Poland
Clinical Research Site #616-004
Kielce, , Poland
Clinical Research Site #616-008
Lublin, , Poland
Clinical Research Site #616-010
Lublin, , Poland
Clinical Research Site #616-012
Poznan, , Poland
Clinical Research Site #616-005
Poznan, , Poland
Clinical Research Site #616-001
Pruszcz Gdański, , Poland
Clinical Research Site #616-007
Warsaw, , Poland
Clinical Research Site #620-007
Guimarães, Braga District, Portugal
Clinical Research Site #620-004
Braga, , Portugal
Clinical Research Site #620-005
Coimbra, , Portugal
Clinical Research Site #620-002
Torres Vedras, , Portugal
Clinical Research Site #630-001
Bayamón, , Puerto Rico
Clinical Research Site #630-003
Rio Piedras, , Puerto Rico
Clinical Research Site #630-002
San Juan, , Puerto Rico
Clinical Research Site #630-005
San Juan, , Puerto Rico
Clinical Research Site #804-006
Dnipro, , Ukraine
Clinical Research Site #804-003
Kharkiv, , Ukraine
Clinical Research Site #804-004
Kiev, , Ukraine
Clinical Research Site #804-005
Kyiv, , Ukraine
Clinical Research Site #804-007
Lviv, , Ukraine
Clinical Research Site #826-003
Blandford Forum, , United Kingdom
Clinical Research Site #826-004
Crowborough, , United Kingdom
Clinical Research Site #826-001
Fulwood, , United Kingdom
Clinical Research Site# 826-006
Manchester, , United Kingdom
Clinical Research Site #826-002
Motherwell, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-000798-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504990-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
20-AVP-786-306
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.