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
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type
- Interventions
- Drug: Placebo
- Registration Number
- NCT03393520
- Brief Summary
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
- Detailed Description
Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.
Approximately 550 participants will be enrolled at approximately 90 centers worldwide.
Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 601
- Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
- Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to baseline that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator
- The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.
- A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of ≥ 4 (moderately ill) at screening and baseline
- Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.
- Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend 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 AD (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, 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 will be assigned to treatment with placebo capsules administered twice a day over a 12-week period. AVP-786; Dose 1 AVP-786 Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period. AVP-786; Dose 2 AVP-786 Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week 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 (CGIS)-Agitation Domain Score Baseline; Week 12
Trial Locations
- Locations (210)
Advanced Research Center, Inc #835
🇺🇸Anaheim, California, United States
ATP Clinical Research, Inc #763
🇺🇸Costa Mesa, California, United States
Crystal Biomedical Research, LLC
🇺🇸Miami Lakes, Florida, United States
Liv Generations of Agritopia / CCT #573
🇺🇸Gilbert, Arizona, United States
New Horizon Research Center Site #795
🇺🇸Miami, Florida, United States
Research Institute of West Kendall
🇺🇸Miami, Florida, United States
Homestead Associates in Research #797
🇺🇸Miami, Florida, United States
City Medical Group RC
🇺🇸Miami, Florida, United States
MD First Research #767
🇺🇸Chandler, Arizona, United States
Medical Advancement Center of Arizona #820
🇺🇸Tempe, Arizona, United States
Clinical Trials Inc.
🇺🇸Little Rock, Arkansas, United States
Rohun Medical Corporation Site #770
🇺🇸Long Beach, California, United States
Torrance Clinical Research Institute, Inc. #826
🇺🇸Lomita, California, United States
Paradigm Clinical Research Centers, Inc.
🇺🇸La Mesa, California, United States
Sunwise Clinical Research #831
🇺🇸Lafayette, California, United States
Havana Research Institute
🇺🇸Pasadena, California, United States
Alliance for Wellness, Inc dba Alliance for Research #789
🇺🇸Long Beach, California, United States
Neurology of Central Florida Rsch Ctr # 803
🇺🇸Altamonte Springs, Florida, United States
Negron Research Services / Humanity Clinical Research #766
🇺🇸Aventura, Florida, United States
SFM Clinical Research, LLC #563
🇺🇸Boca Raton, Florida, United States
Helix Biomedics LLC
🇺🇸Boynton Beach, Florida, United States
Bradenton Research Center #834
🇺🇸Bradenton, Florida, United States
Beautiful Minds Clinical Research Center #808
🇺🇸Cutler Bay, Florida, United States
Clinical Research of Brandon #838
🇺🇸Brandon, Florida, United States
ASCLEPES Research Center #806
🇺🇸Brooksville, Florida, United States
Science Connections, LLC #814
🇺🇸Doral, Florida, United States
ConSalud Medical Research #773
🇺🇸Hialeah, Florida, United States
Direct Helpers Research Center # 801
🇺🇸Hialeah, Florida, United States
New Med Research Inc #812
🇺🇸Hollywood, Florida, United States
Alphab Global Research #793
🇺🇸Jupiter, Florida, United States
Alzheimer's Research and Treatment Center
🇺🇸Lake Worth, Florida, United States
Zynak Clinical Services
🇺🇸Lauderdale Lakes, Florida, United States
Meridien Research - Lakeland Site Site #558
🇺🇸Lakeland, Florida, United States
Adaptive Clinical Research, Inc. Site# 815
🇺🇸Lauderhill, Florida, United States
Innovative Clinical Research, Inc Site #819
🇺🇸Lauderhill, Florida, United States
Agility Medical Research, Inc Site #816
🇺🇸Miami Lakes, Florida, United States
Finlay Medical Research Corp #552
🇺🇸Miami, Florida, United States
Premier Clinical Research Institute, Inc. #817
🇺🇸Miami, Florida, United States
Project4Research #774
🇺🇸Miami, Florida, United States
Central Miami Medical Institute # 798
🇺🇸Miami, Florida, United States
First Class Medical Services #807
🇺🇸Miami, Florida, United States
Miami Jewish Health Systems, Inc. #786
🇺🇸Miami, Florida, United States
Reliant Medical Research, LLC #811
🇺🇸Miami, Florida, United States
Clinical Research Associates of South Florida
🇺🇸Miami, Florida, United States
P&S Research, LLC #805
🇺🇸Miami, Florida, United States
Pharmax Research of South Florida
🇺🇸Miami, Florida, United States
Bayside Clinical Research
🇺🇸New Port Richey, Florida, United States
Innovation Medical Research Center #802
🇺🇸Palmetto, Florida, United States
Quantum Laboratories Site #768
🇺🇸Pompano Beach, Florida, United States
Neurostudies Inc. Site# 796
🇺🇸Port Charlotte, Florida, United States
NeuroStudies. Net, LLC
🇺🇸Decatur, Georgia, United States
DelRicht Research #776
🇺🇸Covington, Louisiana, United States
Alzheimer Disease Center #804
🇺🇸Braintree, Massachusetts, United States
Neurobehavioral Medicine Group #828
🇺🇸Bloomfield, Michigan, United States
Onyx Clinical Research, LLC
🇺🇸Youngstown, Ohio, United States
Oakland Medical Research #762
🇺🇸Troy, Michigan, United States
Precise Research Centers Site #765
🇺🇸Flowood, Mississippi, United States
Galen Research Site #550
🇺🇸Chesterfield, Missouri, United States
Psychiatric Care and Research Center #827
🇺🇸O'Fallon, Missouri, United States
Mid Hudson Medical Research, PLLC #836
🇺🇸New Windsor, New York, United States
Osumc #837
🇺🇸Columbus, Ohio, United States
Nathan S. Kline Institute for Psychiatric Research
🇺🇸Orangeburg, New York, United States
The Neurological Institute #843
🇺🇸Charlotte, North Carolina, United States
NorthStar Medical Research #778
🇺🇸Middleburg Heights, Ohio, United States
New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States
Keystone Clinical Studies, LLC
🇺🇸Norristown, Pennsylvania, United States
Trinity Universal Research Associates Site #821
🇺🇸Carrollton, Texas, United States
Texas Neurology #832
🇺🇸Dallas, Texas, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Bio Pharma Informatic LLC Site #822
🇺🇸Houston, Texas, United States
Katy Neurology #823
🇺🇸Katy, Texas, United States
Bio Pharma Informatic Inc Site #769
🇺🇸Houston, Texas, United States
Ośrodek Alzheimerowski #756
🇵🇱Ścinawa, Poland
Perseverance Research Center
🇺🇸Scottsdale, Arizona, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Semmelweis Egyetem Site #595
🇭🇺Budapest, Hungary
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damian" OOD #710
🇧🇬Sofia, Bulgaria
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
🇭🇺Debrecen, Hungary
Centrum Medyczne Pratia Warszawa
🇵🇱Warszawa, Poland
ClinHouse Centrum Medyczne #755
🇵🇱Zabrze, Poland
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak #586
🇭🇺Budapest, Hungary
Twoja Przychodnia - Centrum Medyczne Nowa Sol #757
🇵🇱Nowa Sól, Poland
Ad71 #727
🇨🇿Praha, Czechia
Liv Generations of Ahwatukee / CCT #784
🇺🇸Phoenix, Arizona, United States
Wasatch Clinical Research, LLC Site #771
🇺🇸Salt Lake City, Utah, United States
Newton Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Orenda Research & Consulting LLC #840
🇺🇸Oklahoma City, Oklahoma, United States
Northpointe Psychiatry #761
🇺🇸Lewisville, Texas, United States
Wellness Clinical Research #824
🇺🇸McKinney, Texas, United States
PRX Research Site #825
🇺🇸Mesquite, Texas, United States
Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
🇮🇹Roma, Italy
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
IPC Research
🇺🇸Waukesha, Wisconsin, United States
Australian Alzheimer's Research Foundation
🇦🇺Nedlands, Australia
Neuro Trials Victoria Pty Ltd
🇦🇺Noble Park, Australia
Medical Center Hipokrat-N EOOD
🇧🇬Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
🇧🇬Pleven, Bulgaria
Center for Mental Health - Ruse
🇧🇬Ruse, Bulgaria
Mental Health Centre Prof.Nikola Shipkovenski #713
🇧🇬Sofia, Bulgaria
Medical Center Stimul
🇧🇬Sofia, Bulgaria
First Multiprofile Hospital for Active Treatment Sofia
🇧🇬Sofia, Bulgaria
Medical Center Sveti Naum #707
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska
🇧🇬Sofia, Bulgaria
Medica Plus Medical Center #705
🇧🇬Veliko Tarnovo, Bulgaria
Diagnostic-consultative center Mladost-М Varna OOD #711
🇧🇬Varna, Bulgaria
Mental Health Center Site #712
🇧🇬Vratsa, Bulgaria
MUDr. Marta Holanová Site# 733
🇨🇿Brno, Czechia
Fakultni Nemocnice u sv. Anny v Brne #722
🇨🇿Brno, Czechia
NeuropsychiatrieHK #729
🇨🇿Hradec Králové, Czechia
Supervize #723
🇨🇿Kutná Hora, Czechia
Clintrial #720
🇨🇿Praha, Czechia
INEP Medical s.r.o. Institut Neuropsychiatricke Pece #730
🇨🇿Praha, Czechia
Neurologicka Ambulance - Forbeli #721
🇨🇿Praha, Czechia
Neuropsychiatrie #726
🇨🇿Praha, Czechia
Vestra Clinics #725
🇨🇿Rychnov nad Kněžnou, Czechia
Centre Hospitalier de Calais
🇫🇷Calais, France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
🇫🇷Caen cedex 9, France
Centre Hospitalier Universitaire Dijon Bourgogn #536
🇫🇷Dijon Cedex, France
Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec #537
🇫🇷Nantes Cedex, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, France
Centre Hospitalier Universitaire Toulouse - Casselardit Ancely #533
🇫🇷Toulouse, France
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord #535
🇫🇷Saint-Etienne, France
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
🇫🇷Vandoeuvre les Nancy, France
Dr. Kenessey Albert Kórház-Rendelőintézet
🇭🇺Balassagyarmat, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Valeomed Egeszsegugyi es Szolgaltato Kft
🇭🇺Esztergom, Hungary
Dr. Mathe es Tarsa Beteti Tarsasa Site #593
🇭🇺Kalocsa, Hungary
Petz Aladár Egyetemi Oktató Kórház Site# 594
🇭🇺Győr, Hungary
CRU Hungary Egészségügyi és Szolgáltató Korlátolt Felelősségű Társaság
🇭🇺Miskolc, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
🇭🇺Nyiregyhaza, Hungary
PsychoTech #580
🇭🇺Pecs, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
🇭🇺Szeged, Hungary
Fejér Megyei Szent György Egyetemi Oktató Kórház
🇭🇺Székesfehérvár, Hungary
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
Centro San Giovanni di Dio - Fatebenefratelli
🇮🇹Brescia, Italy
Azienda Ospedaliero - Universitaria Careggi #610
🇮🇹Firenze, Italy
Università degli studi G.D'Annunzio Chieti Pescara
🇮🇹Chieti, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera San Gerardo di Monza
🇮🇹Monza, Italy
Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi
🇮🇹Ponderano, Italy
Azienda Ospedaliera Sant'Andrea #606
🇮🇹Roma, Italy
Fondazione Policlinico Tor Vergata #609
🇮🇹Roma, Italy
Śródmieście Przychodnia - Bydgoszcz
🇵🇱Bydgoszcz, Poland
Centrum Medyczne Sensemed
🇵🇱Chorzów, Poland
Care Clinic #750
🇵🇱Katowice, Poland
Wielospecjalistyczna Poradnia Lekarska Synapsis #741
🇵🇱Katowice, Poland
Krakowska Akademia Neurologii #740
🇵🇱Kraków, Poland
Pratia MCM Kraków #747
🇵🇱Kraków, Poland
Medycyna Milorzab #743
🇵🇱Lodz, Poland
Centrum Medyczne HCP
🇵🇱Poznań, Poland
Neurologiczny Niepubliczny Zakład Opieki Zdrowotnej
🇵🇱Plewiska, Poland
Brain-Soultherapy #728
🇨🇿Kladno, Czechia
Clinline Services s.r.0 Psychiatricka ambulance #732
🇨🇿Hostivice, Czechia
Fakultní Nemocnice Hradec Králové #724
🇨🇿Hradec Kralové, Czechia
A-Shine s.r.o.
🇨🇿Plzen, Czechia
MAC Clinical Research - Blackpool
🇬🇧Blackpool, United Kingdom
The Alfred Hospital
🇦🇺Parkville, Australia
Solumed Centrum Medyczne #753
🇵🇱Poznań, Poland
RCMed Oddział Sochaczew #510
🇵🇱Sochaczew, Poland
Amonaria Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda #508
🇵🇱Suchy Las, Poland
Centrum Medyczne Euromedis
🇵🇱Szczecin, Poland
Przychodnia Specjalistyczna Prosen Site#758
🇵🇱Warszawa, Poland
Centrum Medyczne NeuroProtect
🇵🇱Warszawa, Poland
ACF Neurological Services
🇿🇦Cape Town, South Africa
Cape Trial Centre #621
🇿🇦Cape Town, South Africa
Apollo Clinical Research #623
🇿🇦Johannesburg, South Africa
Flexivest Fourteen Research Centre #620
🇿🇦Cape Town, South Africa
Medical and Dental Centre #625
🇿🇦Rosebank, South Africa
Dr. Chisto Carel Coetzee
🇿🇦Umhlanga, South Africa
Accellacare Alcobendas #659
🇪🇸Alcobendas, Aocobendas, Spain
Fundació ACE
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebrón
🇪🇸Barcelona, Spain
Fundació Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia #647
🇪🇸Córdoba, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Hospital Universitari de Santa Maria
🇪🇸Lleida, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro - Majadahonda #658
🇪🇸Majadahonda, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario de Salamanca #656
🇪🇸Salamanca, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario Virgen Macarena #649
🇪🇸Sevilla, Spain
Hospital Universitario y Politécnico de La Fe
🇪🇸Valencia, Spain
Complejo Asistencial de Zamora Hospital Virgen de la Concha #652
🇪🇸Zamora, Spain
Hospital Viamed Montecanal #643
🇪🇸Zaragoza, Spain
MAC Clinical Research - Barnsley Site #671
🇬🇧Barnsley, United Kingdom
Research Institute for the Care of Older People
🇬🇧Bath, United Kingdom
MAC Clinical Research - Cannock #672
🇬🇧Cannock, United Kingdom
MAC Clinical Research - Leeds
🇬🇧Leeds, United Kingdom
Re:Cognition Health - London
🇬🇧London, United Kingdom
South London and Maudsley NHS Foundation Trust
🇬🇧London, United Kingdom
MAC Clinical Research - Manchester
🇬🇧Manchester, United Kingdom
Northamptonshire Healthcare NHS Foundation Trust #682
🇬🇧Northampton, United Kingdom
MAC Clinical Research - Liverpool
🇬🇧Prescot, United Kingdom
Southern Health NHS Foundation Trust #679
🇬🇧Southampton, United Kingdom
Avon and Wiltshire Mental Health Partnership NHS Trust
🇬🇧Swindon, United Kingdom
North West Boroughs Healthcare NHS Foundation Trust #685
🇬🇧Warrington, United Kingdom
Core Clinical Research # 772
🇺🇸Everett, Washington, United States
Combined Research Orlando #799
🇺🇸Orlando, Florida, United States
Academic Alliance in Dermatology
🇺🇸Tampa, Florida, United States
VICIS Clinical Research Inc. #777
🇺🇸Tampa, Florida, United States
JSV Clinical Research Study, Inc. #829
🇺🇸Tampa, Florida, United States
Hawaii Pacific Neuroscience #833
🇺🇸Honolulu, Hawaii, United States
Five Towns Neurology PC/Village Site #764
🇺🇸Woodmere, New York, United States
Insight Clinical Trials LLC #570
🇺🇸Beachwood, Ohio, United States
Valley Medical Research Site#788
🇺🇸Centerville, Ohio, United States
Belfast Health and Social Care Trust
🇬🇧Belfast, United Kingdom