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 โฅ 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
๐บ๐ธAnaheim, California, United States
ATP Clinical Research, Inc #763
๐บ๐ธCosta Mesa, California, United States
Crystal Biomedical Research, LLC
๐บ๐ธMiami Lakes, Florida, United States
Liv Generations of Agritopia / CCT #573
๐บ๐ธGilbert, Arizona, United States
New Horizon Research Center Site #795
๐บ๐ธMiami, Florida, United States
Research Institute of West Kendall
๐บ๐ธMiami, Florida, United States
Homestead Associates in Research #797
๐บ๐ธMiami, Florida, United States
City Medical Group RC
๐บ๐ธMiami, Florida, United States
MD First Research #767
๐บ๐ธChandler, Arizona, United States
Medical Advancement Center of Arizona #820
๐บ๐ธTempe, Arizona, United States
Clinical Trials Inc.
๐บ๐ธLittle Rock, Arkansas, United States
Rohun Medical Corporation Site #770
๐บ๐ธLong Beach, California, United States
Torrance Clinical Research Institute, Inc. #826
๐บ๐ธLomita, California, United States
Paradigm Clinical Research Centers, Inc.
๐บ๐ธLa Mesa, California, United States
Sunwise Clinical Research #831
๐บ๐ธLafayette, California, United States
Havana Research Institute
๐บ๐ธPasadena, California, United States
Alliance for Wellness, Inc dba Alliance for Research #789
๐บ๐ธLong Beach, California, United States
Neurology of Central Florida Rsch Ctr # 803
๐บ๐ธAltamonte Springs, Florida, United States
Negron Research Services / Humanity Clinical Research #766
๐บ๐ธAventura, Florida, United States
SFM Clinical Research, LLC #563
๐บ๐ธBoca Raton, Florida, United States
Helix Biomedics LLC
๐บ๐ธBoynton Beach, Florida, United States
Bradenton Research Center #834
๐บ๐ธBradenton, Florida, United States
Beautiful Minds Clinical Research Center #808
๐บ๐ธCutler Bay, Florida, United States
Clinical Research of Brandon #838
๐บ๐ธBrandon, Florida, United States
ASCLEPES Research Center #806
๐บ๐ธBrooksville, Florida, United States
Science Connections, LLC #814
๐บ๐ธDoral, Florida, United States
ConSalud Medical Research #773
๐บ๐ธHialeah, Florida, United States
Direct Helpers Research Center # 801
๐บ๐ธHialeah, Florida, United States
New Med Research Inc #812
๐บ๐ธHollywood, Florida, United States
Alphab Global Research #793
๐บ๐ธJupiter, Florida, United States
Alzheimer's Research and Treatment Center
๐บ๐ธLake Worth, Florida, United States
Zynak Clinical Services
๐บ๐ธLauderdale Lakes, Florida, United States
Meridien Research - Lakeland Site Site #558
๐บ๐ธLakeland, Florida, United States
Adaptive Clinical Research, Inc. Site# 815
๐บ๐ธLauderhill, Florida, United States
Innovative Clinical Research, Inc Site #819
๐บ๐ธLauderhill, Florida, United States
Agility Medical Research, Inc Site #816
๐บ๐ธMiami Lakes, Florida, United States
Finlay Medical Research Corp #552
๐บ๐ธMiami, Florida, United States
Premier Clinical Research Institute, Inc. #817
๐บ๐ธMiami, Florida, United States
Project4Research #774
๐บ๐ธMiami, Florida, United States
Central Miami Medical Institute # 798
๐บ๐ธMiami, Florida, United States
First Class Medical Services #807
๐บ๐ธMiami, Florida, United States
Miami Jewish Health Systems, Inc. #786
๐บ๐ธMiami, Florida, United States
Reliant Medical Research, LLC #811
๐บ๐ธMiami, Florida, United States
Clinical Research Associates of South Florida
๐บ๐ธMiami, Florida, United States
P&S Research, LLC #805
๐บ๐ธMiami, Florida, United States
Pharmax Research of South Florida
๐บ๐ธMiami, Florida, United States
Bayside Clinical Research
๐บ๐ธNew Port Richey, Florida, United States
Innovation Medical Research Center #802
๐บ๐ธPalmetto, Florida, United States
Quantum Laboratories Site #768
๐บ๐ธPompano Beach, Florida, United States
Neurostudies Inc. Site# 796
๐บ๐ธPort Charlotte, Florida, United States
NeuroStudies. Net, LLC
๐บ๐ธDecatur, Georgia, United States
DelRicht Research #776
๐บ๐ธCovington, Louisiana, United States
Alzheimer Disease Center #804
๐บ๐ธBraintree, Massachusetts, United States
Neurobehavioral Medicine Group #828
๐บ๐ธBloomfield, Michigan, United States
Onyx Clinical Research, LLC
๐บ๐ธYoungstown, Ohio, United States
Oakland Medical Research #762
๐บ๐ธTroy, Michigan, United States
Precise Research Centers Site #765
๐บ๐ธFlowood, Mississippi, United States
Galen Research Site #550
๐บ๐ธChesterfield, Missouri, United States
Psychiatric Care and Research Center #827
๐บ๐ธO'Fallon, Missouri, United States
Mid Hudson Medical Research, PLLC #836
๐บ๐ธNew Windsor, New York, United States
Osumc #837
๐บ๐ธColumbus, Ohio, United States
Nathan S. Kline Institute for Psychiatric Research
๐บ๐ธOrangeburg, New York, United States
The Neurological Institute #843
๐บ๐ธCharlotte, North Carolina, United States
NorthStar Medical Research #778
๐บ๐ธMiddleburg Heights, Ohio, United States
New Hope Clinical Research
๐บ๐ธCharlotte, North Carolina, United States
Keystone Clinical Studies, LLC
๐บ๐ธNorristown, Pennsylvania, United States
Trinity Universal Research Associates Site #821
๐บ๐ธCarrollton, Texas, United States
Texas Neurology #832
๐บ๐ธDallas, Texas, United States
InSite Clinical Research
๐บ๐ธDeSoto, Texas, United States
Bio Pharma Informatic LLC Site #822
๐บ๐ธHouston, Texas, United States
Katy Neurology #823
๐บ๐ธKaty, Texas, United States
Bio Pharma Informatic Inc Site #769
๐บ๐ธHouston, Texas, United States
Oลrodek Alzheimerowski #756
๐ต๐ฑลcinawa, Poland
Perseverance Research Center
๐บ๐ธScottsdale, Arizona, United States
Bio Behavioral Health
๐บ๐ธToms River, New Jersey, United States
Semmelweis Egyetem Site #595
๐ญ๐บBudapest, Hungary
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damian" OOD #710
๐ง๐ฌSofia, Bulgaria
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
๐ญ๐บDebrecen, Hungary
Centrum Medyczne Pratia Warszawa
๐ต๐ฑWarszawa, Poland
ClinHouse Centrum Medyczne #755
๐ต๐ฑZabrze, Poland
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak #586
๐ญ๐บBudapest, Hungary
Twoja Przychodnia - Centrum Medyczne Nowa Sol #757
๐ต๐ฑNowa Sรณl, Poland
Ad71 #727
๐จ๐ฟPraha, Czechia
Liv Generations of Ahwatukee / CCT #784
๐บ๐ธPhoenix, Arizona, United States
Wasatch Clinical Research, LLC Site #771
๐บ๐ธSalt Lake City, Utah, United States
Newton Clinical Research
๐บ๐ธOklahoma City, Oklahoma, United States
Orenda Research & Consulting LLC #840
๐บ๐ธOklahoma City, Oklahoma, United States
Northpointe Psychiatry #761
๐บ๐ธLewisville, Texas, United States
Wellness Clinical Research #824
๐บ๐ธMcKinney, Texas, United States
PRX Research Site #825
๐บ๐ธMesquite, Texas, United States
Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
๐ฎ๐นRoma, Italy
Northwest Clinical Research Center
๐บ๐ธBellevue, Washington, United States
IPC Research
๐บ๐ธWaukesha, Wisconsin, United States
Australian Alzheimer's Research Foundation
๐ฆ๐บNedlands, Australia
Neuro Trials Victoria Pty Ltd
๐ฆ๐บNoble Park, Australia
Medical Center Hipokrat-N EOOD
๐ง๐ฌPlovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
๐ง๐ฌPleven, Bulgaria
Center for Mental Health - Ruse
๐ง๐ฌRuse, Bulgaria
Mental Health Centre Prof.Nikola Shipkovenski #713
๐ง๐ฌSofia, Bulgaria
Medical Center Stimul
๐ง๐ฌSofia, Bulgaria
First Multiprofile Hospital for Active Treatment Sofia
๐ง๐ฌSofia, Bulgaria
Medical Center Sveti Naum #707
๐ง๐ฌSofia, Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska
๐ง๐ฌSofia, Bulgaria
Medica Plus Medical Center #705
๐ง๐ฌVeliko Tarnovo, Bulgaria
Diagnostic-consultative center Mladost-ะ Varna OOD #711
๐ง๐ฌVarna, Bulgaria
Mental Health Center Site #712
๐ง๐ฌVratsa, Bulgaria
MUDr. Marta Holanovรก Site# 733
๐จ๐ฟBrno, Czechia
Fakultni Nemocnice u sv. Anny v Brne #722
๐จ๐ฟBrno, Czechia
NeuropsychiatrieHK #729
๐จ๐ฟHradec Krรกlovรฉ, Czechia
Supervize #723
๐จ๐ฟKutnรก Hora, Czechia
Clintrial #720
๐จ๐ฟPraha, Czechia
INEP Medical s.r.o. Institut Neuropsychiatricke Pece #730
๐จ๐ฟPraha, Czechia
Neurologicka Ambulance - Forbeli #721
๐จ๐ฟPraha, Czechia
Neuropsychiatrie #726
๐จ๐ฟPraha, Czechia
Vestra Clinics #725
๐จ๐ฟRychnov nad Knฤลพnou, Czechia
Centre Hospitalier de Calais
๐ซ๐ทCalais, France
Centre Hospitalier Universitaire de Caen - Hรดpital Cรดte de Nacre
๐ซ๐ทCaen cedex 9, France
Centre Hospitalier Universitaire Dijon Bourgogn #536
๐ซ๐ทDijon Cedex, France
Centre Hospitalier Universitaire de Nantes - Hรดpital Nord Laennec #537
๐ซ๐ทNantes Cedex, France
Centre Hospitalier Universitaire de Poitiers
๐ซ๐ทPoitiers, France
Centre Hospitalier Universitaire Toulouse - Casselardit Ancely #533
๐ซ๐ทToulouse, France
Centre Hospitalier Universitaire de Saint-รtienne - Hรดpital Nord #535
๐ซ๐ทSaint-Etienne, France
Centre Hospitalier Universitaire de Nancy - Hรดpital de Brabois
๐ซ๐ทVandoeuvre les Nancy, France
Dr. Kenessey Albert Kรณrhรกz-Rendelลintรฉzet
๐ญ๐บBalassagyarmat, Hungary
Semmelweis Egyetem
๐ญ๐บBudapest, Hungary
Valeomed Egeszsegugyi es Szolgaltato Kft
๐ญ๐บEsztergom, Hungary
Dr. Mathe es Tarsa Beteti Tarsasa Site #593
๐ญ๐บKalocsa, Hungary
Petz Aladรกr Egyetemi Oktatรณ Kรณrhรกz Site# 594
๐ญ๐บGyลr, Hungary
CRU Hungary Egรฉszsรฉgรผgyi รฉs Szolgรกltatรณ Korlรกtolt Felelลssรฉgลฑ Tรกrsasรกg
๐ญ๐บMiskolc, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
๐ญ๐บNyiregyhaza, Hungary
PsychoTech #580
๐ญ๐บPecs, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
๐ญ๐บSzeged, Hungary
Fejรฉr Megyei Szent Gyรถrgy Egyetemi Oktatรณ Kรณrhรกz
๐ญ๐บSzรฉkesfehรฉrvรกr, Hungary
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
๐ฎ๐นBrescia, Italy
Centro San Giovanni di Dio - Fatebenefratelli
๐ฎ๐นBrescia, Italy
Azienda Ospedaliero - Universitaria Careggi #610
๐ฎ๐นFirenze, Italy
Universitร degli studi G.D'Annunzio Chieti Pescara
๐ฎ๐นChieti, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
๐ฎ๐นMilano, Italy
Azienda Ospedaliera San Gerardo di Monza
๐ฎ๐นMonza, Italy
Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi
๐ฎ๐นPonderano, Italy
Azienda Ospedaliera Sant'Andrea #606
๐ฎ๐นRoma, Italy
Fondazione Policlinico Tor Vergata #609
๐ฎ๐นRoma, Italy
ลrรณdmieลcie Przychodnia - Bydgoszcz
๐ต๐ฑBydgoszcz, Poland
Centrum Medyczne Sensemed
๐ต๐ฑChorzรณw, Poland
Care Clinic #750
๐ต๐ฑKatowice, Poland
Wielospecjalistyczna Poradnia Lekarska Synapsis #741
๐ต๐ฑKatowice, Poland
Krakowska Akademia Neurologii #740
๐ต๐ฑKrakรณw, Poland
Pratia MCM Krakรณw #747
๐ต๐ฑKrakรณw, Poland
Medycyna Milorzab #743
๐ต๐ฑLodz, Poland
Centrum Medyczne HCP
๐ต๐ฑPoznaล, Poland
Neurologiczny Niepubliczny Zakลad Opieki Zdrowotnej
๐ต๐ฑPlewiska, Poland
Brain-Soultherapy #728
๐จ๐ฟKladno, Czechia
Clinline Services s.r.0 Psychiatricka ambulance #732
๐จ๐ฟHostivice, Czechia
Fakultnรญ Nemocnice Hradec Krรกlovรฉ #724
๐จ๐ฟHradec Kralovรฉ, Czechia
A-Shine s.r.o.
๐จ๐ฟPlzen, Czechia
MAC Clinical Research - Blackpool
๐ฌ๐งBlackpool, United Kingdom
The Alfred Hospital
๐ฆ๐บParkville, Australia
Solumed Centrum Medyczne #753
๐ต๐ฑPoznaล, Poland
RCMed Oddziaล Sochaczew #510
๐ต๐ฑSochaczew, Poland
Amonaria Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda #508
๐ต๐ฑSuchy Las, Poland
Centrum Medyczne Euromedis
๐ต๐ฑSzczecin, Poland
Przychodnia Specjalistyczna Prosen Site#758
๐ต๐ฑWarszawa, Poland
Centrum Medyczne NeuroProtect
๐ต๐ฑWarszawa, Poland
ACF Neurological Services
๐ฟ๐ฆCape Town, South Africa
Cape Trial Centre #621
๐ฟ๐ฆCape Town, South Africa
Apollo Clinical Research #623
๐ฟ๐ฆJohannesburg, South Africa
Flexivest Fourteen Research Centre #620
๐ฟ๐ฆCape Town, South Africa
Medical and Dental Centre #625
๐ฟ๐ฆRosebank, South Africa
Dr. Chisto Carel Coetzee
๐ฟ๐ฆUmhlanga, South Africa
Accellacare Alcobendas #659
๐ช๐ธAlcobendas, Aocobendas, Spain
Fundaciรณ ACE
๐ช๐ธBarcelona, Spain
Hospital Universitari Vall d'Hebrรณn
๐ช๐ธBarcelona, Spain
Fundaciรณ Hospital de la Santa Creu i Sant Pau
๐ช๐ธBarcelona, Spain
Hospital Clinic de Barcelona
๐ช๐ธBarcelona, Spain
Hospital Universitario Reina Sofia #647
๐ช๐ธCรณrdoba, Spain
Hospital General Universitario de Elche
๐ช๐ธElche, Spain
Hospital Universitari de Santa Maria
๐ช๐ธLleida, Spain
Hospital General Universitario Gregorio Maraรฑรณn
๐ช๐ธMadrid, Spain
Hospital Universitario 12 de Octubre
๐ช๐ธMadrid, Spain
Hospital Universitario La Paz
๐ช๐ธMadrid, Spain
Hospital Universitario Puerta de Hierro - Majadahonda #658
๐ช๐ธMajadahonda, Spain
Clรญnica Universidad de Navarra
๐ช๐ธPamplona, Spain
Hospital Universitario de Salamanca #656
๐ช๐ธSalamanca, Spain
Hospital Universitario Marquรฉs de Valdecilla
๐ช๐ธSantander, Spain
Hospital Universitario Virgen Macarena #649
๐ช๐ธSevilla, Spain
Hospital Universitario y Politรฉcnico de La Fe
๐ช๐ธValencia, Spain
Complejo Asistencial de Zamora Hospital Virgen de la Concha #652
๐ช๐ธZamora, Spain
Hospital Viamed Montecanal #643
๐ช๐ธZaragoza, Spain
MAC Clinical Research - Barnsley Site #671
๐ฌ๐งBarnsley, United Kingdom
Research Institute for the Care of Older People
๐ฌ๐งBath, United Kingdom
MAC Clinical Research - Cannock #672
๐ฌ๐งCannock, United Kingdom
MAC Clinical Research - Leeds
๐ฌ๐งLeeds, United Kingdom
Re:Cognition Health - London
๐ฌ๐งLondon, United Kingdom
South London and Maudsley NHS Foundation Trust
๐ฌ๐งLondon, United Kingdom
MAC Clinical Research - Manchester
๐ฌ๐งManchester, United Kingdom
Northamptonshire Healthcare NHS Foundation Trust #682
๐ฌ๐งNorthampton, United Kingdom
MAC Clinical Research - Liverpool
๐ฌ๐งPrescot, United Kingdom
Southern Health NHS Foundation Trust #679
๐ฌ๐งSouthampton, United Kingdom
Avon and Wiltshire Mental Health Partnership NHS Trust
๐ฌ๐งSwindon, United Kingdom
North West Boroughs Healthcare NHS Foundation Trust #685
๐ฌ๐งWarrington, United Kingdom
Core Clinical Research # 772
๐บ๐ธEverett, Washington, United States
Combined Research Orlando #799
๐บ๐ธOrlando, Florida, United States
Academic Alliance in Dermatology
๐บ๐ธTampa, Florida, United States
VICIS Clinical Research Inc. #777
๐บ๐ธTampa, Florida, United States
JSV Clinical Research Study, Inc. #829
๐บ๐ธTampa, Florida, United States
Hawaii Pacific Neuroscience #833
๐บ๐ธHonolulu, Hawaii, United States
Five Towns Neurology PC/Village Site #764
๐บ๐ธWoodmere, New York, United States
Insight Clinical Trials LLC #570
๐บ๐ธBeachwood, Ohio, United States
Valley Medical Research Site#788
๐บ๐ธCenterville, Ohio, United States
Belfast Health and Social Care Trust
๐ฌ๐งBelfast, United Kingdom