Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type
- Interventions
- Drug: Placebo
- Registration Number
- NCT04408755
- Brief Summary
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
- Detailed Description
Eligible participants for this study had a diagnosis of probable Alzheimer's disease (AD) and had clinically significant, moderate/severe agitation secondary to AD.
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 184
- Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups 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
- Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received AVP-786 matching placebo capsules, twice a day, over a 12-week treatment period. AVP-786-18 AVP-786 Participants received AVP-786-18 (d6-DM 18 milligrams (mg)/Q 4.9 mg) capsules, twice a day, over a 12-week treatment period. AVP-786-42.63 AVP-786 Participants received AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day, over a 12-week treatment period.
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score Baseline; Week 12
- Secondary Outcome Measures
Name Time Method Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation Baseline; Week 12
Trial Locations
- Locations (94)
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 #840-042
🇺🇸Miami, 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
🇺🇸The Woodlands, Texas, 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 #840-097
🇺🇸Bronx, New York, United States
Clinical Research Site #840-072
🇺🇸New Windsor, New York, United States
Clinical Research Site #840-095
🇺🇸Monroe, North Carolina, 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 #840-025
🇺🇸Richmond, Virginia, United States
Clinical Research Site #100-115
🇧🇬Pernik, Bulgaria
Clinical Research Site #100-112
🇧🇬Pleven, 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, Region Nordjylland, Denmark
Clinical Research Site #276-017
🇩🇪Böblingen, Baden-Württemberg, Germany
Clinical Research Site #276-005
🇩🇪Bad Homburg Vor Der Höhe, Hessen, Germany
Clinical Research Site #276-012
🇩🇪Gera, Thüringen, 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
🇬🇷Thessaloníki, Greece
Clinical Research Site #616-015
🇵🇱Sochaczew, Mazowieckie, Poland
Clinical Research Site #616-010
🇵🇱Lublin, Poland
Clinical Research Site #620-007
🇵🇹Guimarães, Braga, Portugal
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# 826-006
🇬🇧Manchester, United Kingdom
Clinical Research Site #100-106
🇧🇬Plovdiv, Bulgaria
Clinical Research Site #100-102
🇧🇬Sofia, Bulgaria
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 #616-018
🇵🇱Zabrze, Katowice, Poland
Clinical Research Site #616-009
🇵🇱Bydgoszcz, Kujawsko-Pomorskie, Poland
Clinical Research Site #616-006
🇵🇱Lublin, Lubelskie, 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 #616-012
🇵🇱Poznan, Poland
Clinical Research Site #616-005
🇵🇱Poznan, Poland
Clinical Research Site #616-001
🇵🇱Pruszcz Gdanski, Poland
Clinical Research Site #616-007
🇵🇱Warszawa, Poland
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
🇵🇷Bayamon, Puerto Rico
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 #826-002
🇬🇧Motherwell, United Kingdom
Clinical Research Site #840-081
🇺🇸Fort Smith, Arkansas, 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 #840-056
🇺🇸Brandon, Florida, 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 #840-009
🇺🇸Atlantis, 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 #840-004
🇺🇸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 #840-003
🇺🇸Miami, Florida, United States
Clinical Research Site #840-036
🇺🇸Orlando, Florida, United States
Clinical Research Site #840-060
🇺🇸Canton, Ohio, United States