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

PHASE3CompletedINTERVENTIONAL
Enrollment

601

Participants

Timeline

Start Date

October 13, 2017

Primary Completion Date

November 17, 2023

Study Completion Date

December 14, 2023

Conditions
Agitation in Patients With Dementia of the Alzheimer's Type
Interventions
DRUG

Placebo

oral capsules

DRUG

AVP-786

oral capsules

Trial Locations (211)

1000

Mental Health Centre Prof.Nikola Shipkovenski #713, Sofia

1083

Semmelweis Egyetem Site #595, Budapest

1408

"DCC Sv. Vrach and Sv. Sv. Kuzma and Damian OOD #710", Sofia

3000

Mental Health Center Site #712, Vratsa

3020

Diagnostic-consultative center Mladost-М Varna OOD #711, Varna

6300

Dr. Mathe es Tarsa Beteti Tarsasa Site #593, Kalocsa

9024

Petz Aladár Egyetemi Oktató Kórház Site# 594, Győr

10962

Nathan S. Kline Institute for Psychiatric Research, Orangeburg

11598

Five Towns Neurology PC/Village Site #764, Woodmere

12553

Mid Hudson Medical Research, PLLC #836, New Windsor

19403

Keystone Clinical Studies, LLC, Norristown

28100

Accellacare Alcobendas #659, Alcobendas

28204

The Neurological Institute #843, Charlotte

28211

New Hope Clinical Research, Charlotte

28222

Hospital Universitario Puerta de Hierro - Majadahonda #658, Majadahonda

30033

NeuroStudies. Net, LLC, Decatur

32714

Neurology of Central Florida Rsch Ctr # 803, Altamonte Springs

32807

Combined Research Orlando #799, Orlando

33012

ConSalud Medical Research #773, Hialeah

Direct Helpers Research Center # 801, Hialeah

33014

Crystal Biomedical Research, LLC, Miami Lakes

33016

Agility Medical Research, Inc Site #816, Miami Lakes

33020

New Med Research Inc #812, Hollywood

33032

Homestead Associates in Research #797, Miami

33064

Quantum Laboratories Site #768, Pompano Beach

33122

Premier Clinical Research Institute, Inc. #817, Miami

33125

Central Miami Medical Institute # 798, Miami

Project4Research #774, Miami

33126

City Medical Group RC, Miami

Finlay Medical Research Corp #552, Miami

First Class Medical Services #807, Miami

33137

Miami Jewish Health Systems, Inc. #786, Miami

33157

Beautiful Minds Clinical Research Center #808, Cutler Bay

Innovation Medical Research Center #802, Palmetto

33165

New Horizon Research Center Site #795, Miami

Reliant Medical Research, LLC #811, Miami

33172

Clinical Research Associates of South Florida, Miami

33175

P&S Research, LLC #805, Miami

Pharmax Research of South Florida, Miami

33178

Science Connections, LLC #814, Doral

33180

Negron Research Services / Humanity Clinical Research #766, Aventura

33186

Research Institute of West Kendall, Miami

33313

Zynak Clinical Services, Lauderdale Lakes

33319

Adaptive Clinical Research, Inc. Site# 815, Lauderhill

Innovative Clinical Research, Inc Site #819, Lauderhill

33436

Helix Biomedics LLC, Boynton Beach

33449

Alzheimer's Research and Treatment Center, Lake Worth

33458

Alphab Global Research #793, Jupiter

33487

SFM Clinical Research, LLC #563, Boca Raton

33511

Clinical Research of Brandon #838, Brandon

33615

VICIS Clinical Research Inc. #777, Tampa

33617

Academic Alliance in Dermatology, Tampa

33634

JSV Clinical Research Study, Inc. #829, Tampa

33805

Meridien Research - Lakeland Site Site #558, Lakeland

33952

Neurostudies Inc. Site# 796, Port Charlotte

34205

Bradenton Research Center #834, Bradenton

34613

ASCLEPES Research Center #806, Brooksville

34655

Bayside Clinical Research, New Port Richey

39232

Precise Research Centers Site #765, Flowood

43221

Osumc #837, Columbus

44093

Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec #537, Nantes

44122

Insight Clinical Trials LLC #570, Beachwood

44130

NorthStar Medical Research #778, Middleburg Heights

44505

Onyx Clinical Research, LLC, Youngstown

45459

Valley Medical Research Site#788, Centerville

48085

Oakland Medical Research #762, Troy

48302

Neurobehavioral Medicine Group #828, Bloomfield

48723

Onyx Clinical Research, LLC, Caro

53188

IPC Research, Waukesha

61500

MUDr. Marta Holanová Site# 733, Brno

63005

Galen Research Site #550, Chesterfield

63368

Psychiatric Care and Research Center #827, O'Fallon

70443

DelRicht Research #776, Covington

72205

Clinical Trials Inc., Little Rock

73102

Newton Clinical Research, Oklahoma City

73170

Orenda Research & Consulting LLC #840, Oklahoma City

75007

Trinity Universal Research Associates Site #821, Carrollton

75057

Northpointe Psychiatry #761, Lewisville

75071

Wellness Clinical Research #824, McKinney

75115

InSite Clinical Research, DeSoto

75149

PRX Research Site #825, Mesquite

75206

Texas Neurology #832, Dallas

77043

Bio Pharma Informatic LLC Site #822, Houston

77084

Bio Pharma Informatic Inc Site #769, Houston

77450

Katy Neurology #823, Katy

84107

Wasatch Clinical Research, LLC Site #771, Salt Lake City

85048

Liv Generations of Ahwatukee / CCT #784, Phoenix

85254

Perseverance Research Center, Scottsdale

85283

Medical Advancement Center of Arizona #820, Tempe

85286

MD First Research #767, Chandler

85296

Liv Generations of Agritopia / CCT #573, Gilbert

90717

Torrance Clinical Research Institute, Inc. #826, Lomita

90805

Rohun Medical Corporation Site #770, Long Beach

90807

Alliance for Wellness, Inc dba Alliance for Research #789, Long Beach

91105

Havana Research Institute, Pasadena

91942

Paradigm Clinical Research Centers, Inc., La Mesa

92626

ATP Clinical Research, Inc #763, Costa Mesa

92805

Advanced Research Center, Inc #835, Anaheim

94549

Sunwise Clinical Research #831, Lafayette

96817

Hawaii Pacific Neuroscience #833, Honolulu

98007

Northwest Clinical Research Center, Bellevue

98201

Core Clinical Research # 772, Everett

02184

Alzheimer Disease Center #804, Braintree

08755

Bio Behavioral Health, Toms River

Unknown

Australian Alzheimer's Research Foundation, Nedlands

Neuro Trials Victoria Pty Ltd, Noble Park

The Alfred Hospital, Parkville

University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven

Medical Center Hipokrat-N EOOD, Plovdiv

Center for Mental Health - Ruse, Rousse

First Multiprofile Hospital for Active Treatment Sofia, Sofia

Medical Center Stimul, Sofia

Medical Center Sveti Naum #707, Sofia

University Multiprofile Hospital for Active Treatment Alexandrovska, Sofia

Medica Plus Medical Center #705, Veliko Tarnovo

Fakultni Nemocnice u sv. Anny v Brne #722, Brno

Clinline Services s.r.0 Psychiatricka ambulance #732, Hostivice

Fakultní Nemocnice Hradec Králové #724, Hradec Kralové

NeuropsychiatrieHK #729, Hradec Králové

Brain-Soultherapy #728, Kladno

Supervize #723, Kutná Hora

A-Shine s.r.o., Pilsen

Ad71 #727, Prague

Clintrial #720, Prague

INEP Medical s.r.o. Institut Neuropsychiatricke Pece #730, Prague

Neurologicka Ambulance - Forbeli #721, Prague

Neuropsychiatrie #726, Prague

Vestra Clinics #725, Rychnov nad Kněžnou

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre, Caen

Centre Hospitalier de Calais, Calais

Centre Hospitalier Universitaire Dijon Bourgogn #536, Dijon

Centre Hospitalier Universitaire de Poitiers, Poitiers

Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord #535, Saint-Etienne

Centre Hospitalier Universitaire Toulouse - Casselardit Ancely #533, Toulouse

Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois, Vandœuvre-lès-Nancy

Dr. Kenessey Albert Kórház-Rendelőintézet, Balassagyarmat

Semmelweis Egyetem, Budapest

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak #586, Budapest

Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz, Debrecen

Valeomed Egeszsegugyi es Szolgaltato Kft, Esztergom

CRU Hungary Egészségügyi és Szolgáltató Korlátolt Felelősségű Társaság, Miskolc

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

PsychoTech #580, Pécs

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

Fejér Megyei Szent György Egyetemi Oktató Kórház, Székesfehérvár

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia

Centro San Giovanni di Dio - Fatebenefratelli, Brescia

Università degli studi G.D'Annunzio Chieti Pescara, Chieti

Azienda Ospedaliero - Universitaria Careggi #610, Florence

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Azienda Ospedaliera San Gerardo di Monza, Monza

Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi, Ponderano

Azienda Ospedaliera Sant'Andrea #606, Roma

Fondazione Policlinico Tor Vergata #609, Roma

Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico, Roma

Śródmieście Przychodnia - Bydgoszcz, Bydgoszcz

Centrum Medyczne Sensemed, Chorzów

Care Clinic #750, Katowice

Wielospecjalistyczna Poradnia Lekarska Synapsis #741, Katowice

Krakowska Akademia Neurologii #740, Krakow

Pratia MCM Kraków #747, Krakow

Medycyna Milorzab #743, Lodz

Neurologiczny Niepubliczny Zakład Opieki Zdrowotnej, Plewiska

Centrum Medyczne HCP, Poznan

Solumed Centrum Medyczne #753, Poznan

Centrum Medyczne Euromedis, Szczecin

Centrum Medyczne NeuroProtect, Warsaw

Centrum Medyczne Pratia Warszawa, Warsaw

ACF Neurological Services, Cape Town

Cape Trial Centre #621, Cape Town

Flexivest Fourteen Research Centre #620, Cape Town

Apollo Clinical Research #623, Johannesburg

Medical and Dental Centre #625, Rosebank

Dr. Chisto Carel Coetzee, Umhlanga

Fundació ACE, Barcelona

Fundació Hospital de la Santa Creu i Sant Pau, Barcelona

Hospital Clinic de Barcelona, Barcelona

Hospital Universitari Vall d'Hebrón, Barcelona

Hospital Universitario Reina Sofia #647, Córdoba

Hospital General Universitario de Elche, Elche

Hospital Universitari de Santa Maria, Lleida

Hospital General Universitario Gregorio Marañón, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Paz, Madrid

Clínica Universidad de Navarra, Pamplona

Hospital Universitario de Salamanca #656, Salamanca

Hospital Universitario Marqués de Valdecilla, Santander

Hospital Universitario Virgen Macarena #649, Seville

Hospital Universitario y Politécnico de La Fe, Valencia

Complejo Asistencial de Zamora Hospital Virgen de la Concha #652, Zamora

Hospital Viamed Montecanal #643, Zaragoza

MAC Clinical Research - Barnsley Site #671, Barnsley

Research Institute for the Care of Older People, Bath

Belfast Health and Social Care Trust, Belfast

MAC Clinical Research - Blackpool, Blackpool

MAC Clinical Research - Cannock #672, Cannock

MAC Clinical Research - Leeds, Leeds

Re:Cognition Health - London, London

South London and Maudsley NHS Foundation Trust, London

MAC Clinical Research - Manchester, Manchester

Northamptonshire Healthcare NHS Foundation Trust #682, Northampton

MAC Clinical Research - Liverpool, Prescot

Southern Health NHS Foundation Trust #679, Southampton

Avon and Wiltshire Mental Health Partnership NHS Trust, Swindon

North West Boroughs Healthcare NHS Foundation Trust #685, Warrington

67-100

Twoja Przychodnia - Centrum Medyczne Nowa Sol #757, Nowa Sól

96-500

RCMed Oddział Sochaczew #510, Sochaczew

62-002

Amonaria Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda #508, Suchy Las

59-330

Ośrodek Alzheimerowski #756, Ścinawa

01-231

Przychodnia Specjalistyczna Prosen Site#758, Warsaw

41-807

ClinHouse Centrum Medyczne #755, Zabrze

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT03393520 - 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 | Biotech Hunter | Biotech Hunter