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
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess 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
2 other identifiers
interventional
601
11 countries
211
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2017
Longer than P75 for phase_3
211 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2017
CompletedFirst Submitted
Initial submission to the registry
January 3, 2018
CompletedFirst Posted
Study publicly available on registry
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2023
CompletedNovember 20, 2024
November 1, 2024
6.1 years
January 3, 2018
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Baseline; Week 12
Secondary Outcomes (1)
Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score
Baseline; Week 12
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
AVP-786; Dose 1
EXPERIMENTALParticipants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.
AVP-786; Dose 2
EXPERIMENTALParticipants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (211)
MD First Research #767
Chandler, Arizona, 85286, United States
Liv Generations of Agritopia / CCT #573
Gilbert, Arizona, 85296, United States
Liv Generations of Ahwatukee / CCT #784
Phoenix, Arizona, 85048, United States
Perseverance Research Center
Scottsdale, Arizona, 85254, United States
Medical Advancement Center of Arizona #820
Tempe, Arizona, 85283, United States
Clinical Trials Inc.
Little Rock, Arkansas, 72205, United States
Advanced Research Center, Inc #835
Anaheim, California, 92805, United States
ATP Clinical Research, Inc #763
Costa Mesa, California, 92626, United States
Paradigm Clinical Research Centers, Inc.
La Mesa, California, 91942, United States
Sunwise Clinical Research #831
Lafayette, California, 94549, United States
Torrance Clinical Research Institute, Inc. #826
Lomita, California, 90717, United States
Rohun Medical Corporation Site #770
Long Beach, California, 90805, United States
Alliance for Wellness, Inc dba Alliance for Research #789
Long Beach, California, 90807, United States
Havana Research Institute
Pasadena, California, 91105, United States
Neurology of Central Florida Rsch Ctr # 803
Altamonte Springs, Florida, 32714, United States
Negron Research Services / Humanity Clinical Research #766
Aventura, Florida, 33180, United States
SFM Clinical Research, LLC #563
Boca Raton, Florida, 33487, United States
Helix Biomedics LLC
Boynton Beach, Florida, 33436, United States
Bradenton Research Center #834
Bradenton, Florida, 34205, United States
Clinical Research of Brandon #838
Brandon, Florida, 33511, United States
ASCLEPES Research Center #806
Brooksville, Florida, 34613, United States
Beautiful Minds Clinical Research Center #808
Cutler Bay, Florida, 33157, United States
Science Connections, LLC #814
Doral, Florida, 33178, United States
ConSalud Medical Research #773
Hialeah, Florida, 33012, United States
Direct Helpers Research Center # 801
Hialeah, Florida, 33012, United States
New Med Research Inc #812
Hollywood, Florida, 33020, United States
Alphab Global Research #793
Jupiter, Florida, 33458, United States
Alzheimer's Research and Treatment Center
Lake Worth, Florida, 33449, United States
Meridien Research - Lakeland Site Site #558
Lakeland, Florida, 33805, United States
Zynak Clinical Services
Lauderdale Lakes, Florida, 33313, United States
Adaptive Clinical Research, Inc. Site# 815
Lauderhill, Florida, 33319, United States
Innovative Clinical Research, Inc Site #819
Lauderhill, Florida, 33319, United States
Homestead Associates in Research #797
Miami, Florida, 33032, United States
Premier Clinical Research Institute, Inc. #817
Miami, Florida, 33122, United States
Central Miami Medical Institute # 798
Miami, Florida, 33125, United States
Project4Research #774
Miami, Florida, 33125, United States
City Medical Group RC
Miami, Florida, 33126, United States
Finlay Medical Research Corp #552
Miami, Florida, 33126, United States
First Class Medical Services #807
Miami, Florida, 33126, United States
Miami Jewish Health Systems, Inc. #786
Miami, Florida, 33137, United States
New Horizon Research Center Site #795
Miami, Florida, 33165, United States
Reliant Medical Research, LLC #811
Miami, Florida, 33165, United States
Clinical Research Associates of South Florida
Miami, Florida, 33172, United States
P&S Research, LLC #805
Miami, Florida, 33175, United States
Pharmax Research of South Florida
Miami, Florida, 33175, United States
Research Institute of West Kendall
Miami, Florida, 33186, United States
Crystal Biomedical Research, LLC
Miami Lakes, Florida, 33014, United States
Agility Medical Research, Inc Site #816
Miami Lakes, Florida, 33016, United States
Bayside Clinical Research
New Port Richey, Florida, 34655, United States
Combined Research Orlando #799
Orlando, Florida, 32807, United States
Innovation Medical Research Center #802
Palmetto, Florida, 33157, United States
Quantum Laboratories Site #768
Pompano Beach, Florida, 33064, United States
Neurostudies Inc. Site# 796
Port Charlotte, Florida, 33952, United States
VICIS Clinical Research Inc. #777
Tampa, Florida, 33615, United States
Academic Alliance in Dermatology
Tampa, Florida, 33617, United States
JSV Clinical Research Study, Inc. #829
Tampa, Florida, 33634, United States
NeuroStudies. Net, LLC
Decatur, Georgia, 30033, United States
Hawaii Pacific Neuroscience #833
Honolulu, Hawaii, 96817, United States
DelRicht Research #776
Covington, Louisiana, 70443, United States
Alzheimer Disease Center #804
Braintree, Massachusetts, 02184, United States
Neurobehavioral Medicine Group #828
Bloomfield, Michigan, 48302, United States
Onyx Clinical Research, LLC
Caro, Michigan, 48723, United States
Oakland Medical Research #762
Troy, Michigan, 48085, United States
Precise Research Centers Site #765
Flowood, Mississippi, 39232, United States
Galen Research Site #550
Chesterfield, Missouri, 63005, United States
Psychiatric Care and Research Center #827
O'Fallon, Missouri, 63368, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Mid Hudson Medical Research, PLLC #836
New Windsor, New York, 12553, United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, 10962, United States
Five Towns Neurology PC/Village Site #764
Woodmere, New York, 11598, United States
The Neurological Institute #843
Charlotte, North Carolina, 28204, United States
New Hope Clinical Research
Charlotte, North Carolina, 28211, United States
Insight Clinical Trials LLC #570
Beachwood, Ohio, 44122, United States
Valley Medical Research Site#788
Centerville, Ohio, 45459, United States
Osumc #837
Columbus, Ohio, 43221, United States
NorthStar Medical Research #778
Middleburg Heights, Ohio, 44130, United States
Onyx Clinical Research, LLC
Youngstown, Ohio, 44505, United States
Newton Clinical Research
Oklahoma City, Oklahoma, 73102, United States
Orenda Research & Consulting LLC #840
Oklahoma City, Oklahoma, 73170, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19403, United States
Trinity Universal Research Associates Site #821
Carrollton, Texas, 75007, United States
Texas Neurology #832
Dallas, Texas, 75206, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Bio Pharma Informatic LLC Site #822
Houston, Texas, 77043, United States
Bio Pharma Informatic Inc Site #769
Houston, Texas, 77084, United States
Katy Neurology #823
Katy, Texas, 77450, United States
Northpointe Psychiatry #761
Lewisville, Texas, 75057, United States
Wellness Clinical Research #824
McKinney, Texas, 75071, United States
PRX Research Site #825
Mesquite, Texas, 75149, United States
Wasatch Clinical Research, LLC Site #771
Salt Lake City, Utah, 84107, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Core Clinical Research # 772
Everett, Washington, 98201, United States
IPC Research
Waukesha, Wisconsin, 53188, United States
Australian Alzheimer's Research Foundation
Nedlands, Australia
Neuro Trials Victoria Pty Ltd
Noble Park, Australia
The Alfred Hospital
Parkville, Australia
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
Pleven, Bulgaria
Medical Center Hipokrat-N EOOD
Plovdiv, Bulgaria
Center for Mental Health - Ruse
Rousse, Bulgaria
Mental Health Centre Prof.Nikola Shipkovenski #713
Sofia, 1000, Bulgaria
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damian" OOD #710
Sofia, 1408, Bulgaria
First Multiprofile Hospital for Active Treatment Sofia
Sofia, Bulgaria
Medical Center Stimul
Sofia, Bulgaria
Medical Center Sveti Naum #707
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska
Sofia, Bulgaria
Diagnostic-consultative center Mladost-М Varna OOD #711
Varna, 3020, Bulgaria
Medica Plus Medical Center #705
Veliko Tarnovo, Bulgaria
Mental Health Center Site #712
Vratsa, 3000, Bulgaria
MUDr. Marta Holanová Site# 733
Brno, 61500, Czechia
Fakultni Nemocnice u sv. Anny v Brne #722
Brno, Czechia
Clinline Services s.r.0 Psychiatricka ambulance #732
Hostivice, Czechia
Fakultní Nemocnice Hradec Králové #724
Hradec Kralové, Czechia
NeuropsychiatrieHK #729
Hradec Králové, Czechia
Brain-Soultherapy #728
Kladno, Czechia
Supervize #723
Kutná Hora, Czechia
A-Shine s.r.o.
Pilsen, Czechia
Ad71 #727
Prague, Czechia
Clintrial #720
Prague, Czechia
INEP Medical s.r.o. Institut Neuropsychiatricke Pece #730
Prague, Czechia
Neurologicka Ambulance - Forbeli #721
Prague, Czechia
Neuropsychiatrie #726
Prague, Czechia
Vestra Clinics #725
Rychnov nad Kněžnou, Czechia
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
Caen, France
Centre Hospitalier de Calais
Calais, France
Centre Hospitalier Universitaire Dijon Bourgogn #536
Dijon, France
Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec #537
Nantes, 44093, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord #535
Saint-Etienne, France
Centre Hospitalier Universitaire Toulouse - Casselardit Ancely #533
Toulouse, France
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, France
Dr. Kenessey Albert Kórház-Rendelőintézet
Balassagyarmat, Hungary
Semmelweis Egyetem Site #595
Budapest, 1083, Hungary
Semmelweis Egyetem
Budapest, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak #586
Budapest, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
Debrecen, Hungary
Valeomed Egeszsegugyi es Szolgaltato Kft
Esztergom, Hungary
Petz Aladár Egyetemi Oktató Kórház Site# 594
Győr, 9024, Hungary
Dr. Mathe es Tarsa Beteti Tarsasa Site #593
Kalocsa, 6300, Hungary
CRU Hungary Egészségügyi és Szolgáltató Korlátolt Felelősségű Társaság
Miskolc, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, Hungary
PsychoTech #580
Pécs, 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
Università degli studi G.D'Annunzio Chieti Pescara
Chieti, Italy
Azienda Ospedaliero - Universitaria Careggi #610
Florence, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 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
Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
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
Krakow, Poland
Pratia MCM Kraków #747
Krakow, Poland
Medycyna Milorzab #743
Lodz, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol #757
Nowa Sól, 67-100, Poland
Neurologiczny Niepubliczny Zakład Opieki Zdrowotnej
Plewiska, Poland
Centrum Medyczne HCP
Poznan, Poland
Solumed Centrum Medyczne #753
Poznan, Poland
RCMed Oddział Sochaczew #510
Sochaczew, 96-500, Poland
Amonaria Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda #508
Suchy Las, 62-002, Poland
Centrum Medyczne Euromedis
Szczecin, Poland
Ośrodek Alzheimerowski #756
Ścinawa, 59-330, Poland
Przychodnia Specjalistyczna Prosen Site#758
Warsaw, 01-231, Poland
Centrum Medyczne NeuroProtect
Warsaw, Poland
Centrum Medyczne Pratia Warszawa
Warsaw, Poland
ClinHouse Centrum Medyczne #755
Zabrze, 41-807, Poland
ACF Neurological Services
Cape Town, South Africa
Cape Trial Centre #621
Cape Town, South Africa
Flexivest Fourteen Research Centre #620
Cape Town, South Africa
Apollo Clinical Research #623
Johannesburg, South Africa
Medical and Dental Centre #625
Rosebank, South Africa
Dr. Chisto Carel Coetzee
Umhlanga, South Africa
Accellacare Alcobendas #659
Alcobendas, Aocobendas, 28100, Spain
Fundació ACE
Barcelona, Spain
Fundació Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebrón
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, 28222, 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
Seville, 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
Belfast Health and Social Care Trust
Belfast, United Kingdom
MAC Clinical Research - Blackpool
Blackpool, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2018
First Posted
January 8, 2018
Study Start
October 13, 2017
Primary Completion
November 17, 2023
Study Completion
December 14, 2023
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.