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
Launched by OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC. · Jul 6, 2020
Trial Information
Current as of June 13, 2025
Terminated
Keywords
ClinConnect Summary
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 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.
241 participants were enrolled into the study.
Study medication was administered orally twice daily from Day 1 through Day 85.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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
About Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc. is a leading biopharmaceutical company dedicated to advancing innovative treatments for unmet medical needs. As a subsidiary of Otsuka Pharmaceutical Co., Ltd., the organization focuses on the research, development, and commercialization of novel therapies across various therapeutic areas, including psychiatry, neurology, and oncology. With a commitment to scientific excellence and patient-centric solutions, Otsuka Pharmaceutical Development & Commercialization leverages cutting-edge technology and collaborative partnerships to enhance healthcare outcomes and improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Las Vegas, Nevada, United States
Phoenix, Arizona, United States
Encino, California, United States
Hallandale Beach, Florida, United States
Anaheim, California, United States
Lafayette, California, United States
Panorama City, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Doral, Florida, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Lomita, California, United States
Los Angeles, California, United States
San Diego, California, United States
Santa Ana, California, United States
Wilmington, Delaware, United States
Bradenton, Florida, United States
Coral Springs, Florida, United States
Lady Lake, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Pensacola, Florida, United States
West Palm Beach, Florida, United States
Winter Park, Florida, United States
Honolulu, Hawaii, United States
Meridian, Idaho, United States
New Bedford, Massachusetts, United States
Newton, Massachusetts, United States
Bloomfield Township, Michigan, United States
O'fallon, Missouri, United States
Buffalo, New York, United States
Manhasset, New York, United States
New Hyde Park, New York, United States
Cypress, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Alexandria, Virginia, United States
Fairfax, Virginia, United States
Leuven, , Belgium
Liège, , Belgium
Kelowna, British Columbia, Canada
Sarnia, Ontario, Canada
Montreal, Quebec, Canada
Quebec City, Quebec, Canada
Sherbrooke, Quebec, Canada
Bogota, Columbia, Colombia
Pereira, Columbia, Colombia
Florida Blanca, Santander, Colombia
Bello, , Colombia
Bogotá, , Colombia
Gyöngyös, Heves, Hungary
Budapest, , Hungary
Budapest, , Hungary
Zalaegerszeg, , Hungary
Amsterdam, , Netherlands
Rimavska Sobota, Sobota, Slovakia
Bardejov, , Slovakia
Trencin, , Slovakia
Vranov Nad Topľou, , Slovakia
Begunje Na Gorenjskem, , Slovenia
Ljubljana, , Slovenia
Nova Gorica, , Slovenia
Oviedo, Asturias, Spain
Burgos, , Spain
Coslada, , Spain
Madrid, , Spain
Sant Cugat Del Vallès, , Spain
Terrassa, , Spain
Los Angeles, California, United States
Monterrey, , Mexico
Rijeka, , Croatia
Zagreb, , Croatia
Merida, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Sinaloa, , Mexico
Brussel, , Belgium
Sarnia, Ontario, Canada
Santiago De Chile, , Chile
Santiago De Chile, , Chile
Zagreb, , Croatia
Zagreb, , Croatia
Banská Bystrica, , Slovakia
Wilmington, Delaware, United States
Detroit, Michigan, United States
Las Vegas, Nevada, United States
Neptune, New Jersey, United States
Sherbrooke, Quebec, Canada
Antofagasta, , Chile
Santiago, , Chile
Zagreb, , Croatia
Zagreb, , Croatia
Košice, , Slovakia
Chicago, Illinois, United States
Saltillo, , Mexico
Maribor, , Slovenia
Houston, Texas, United States
Boston, Massachusetts, United States
Monterrey, , Mexico
Tlalnepantla, , Mexico
Independencia, , Chile
Apopka, Florida, United States
Anaheim, California, United States
Lafayette, California, United States
Lomita, California, United States
Bradenton, Florida, United States
Bloomfield Township, Michigan, United States
O'fallon, Missouri, United States
Cypress, Texas, United States
Dallas, Texas, United States
Dubnica Nad Váhom, Bratislavský Kraj, Slovakia
Santa Ana, California, United States
Meridian, Idaho, United States
Alexandria, Virginia, United States
Sarnia, Ontario, Canada
Pula, Istarska županija, Croatia
Cork, , Ireland
Cork, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Murska Sobota, Brezovica, Slovenia
Seville, Andalucía, Spain
Oviedo, Asturias, Spain
Palma De Mallorca, Baleares, Spain
Alicante, Valenciana, Comunitat, Spain
Sant Cugat Del Vallès, , Spain
Terrassa, , Spain
Long Beach, California, United States
Miami, Florida, United States
Mesquite, Texas, United States
Costa Mesa, California, United States
Los Angeles, California, United States
Clermont, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Pensacola, Florida, United States
New Bedford, Massachusetts, United States
El Paso, Texas, United States
Fairfax, Virginia, United States
Alken, Limburg, Belgium
Cape Coral, Florida, United States
Kissimmee, Florida, United States
Orlando, Florida, United States
Phoenix, Arizona, United States
Panorama City, California, United States
Hallandale, Florida, United States
Lady Lake, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Buffalo, New York, United States
Manhasset, New York, United States
New Hyde Park, New York, United States
Houston, Texas, United States
Kelowna, British Columbia, Canada
Quebec City, Quebec, Canada
Viña Del Mar, Region Metropolitana De Santiago, Chile
Independencia, , Chile
Bogota, Columbia, Colombia
Pereira, Columbia, Colombia
Florida Blanca, Santander, Colombia
Bello, , Colombia
Bogota, , Colombia
Bogotá, , Colombia
Gyöngyös, Heves, Hungary
Budapest, , Hungary
Budapest, , Hungary
Rimavska Sobota, Sobota, Slovakia
Bardejov, , Slovakia
Trencin, , Slovakia
Vranov Nad Topľou, , Slovakia
Begunje Na Gorenjskem, , Slovenia
Ljubljana, , Slovenia
Ljubljana, , Slovenia
Madrid, , Spain
Madrid, , Spain
Hallandale Beach, Florida, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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