Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

April 5, 2024 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.

Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks).

Approximately 1200 participants will be enrolled at approximately 250 centers globally.

All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Ruse, Bulgaria
        • Completed
        • Center for Mental Health - Ruse
      • Sofia, Bulgaria, 1000
        • Active, not recruiting
        • Mental Health Centre Prof. Nikola Shipkovenski
      • Sofia, Bulgaria, 1113
        • Active, not recruiting
        • Medical Center Sveti Naum
      • Sofia, Bulgaria, 1408
        • Active, not recruiting
        • Vrach and Sv. Sv. Kuzma and Damian
      • Sofia, Bulgaria
        • Active, not recruiting
        • University Multiprofile Hospital for Active Treatment Alexandrovska
      • Varna, Bulgaria, 9020
        • Active, not recruiting
        • Medical Center Mladost-M
      • Veliko Tarnovo, Bulgaria
        • Active, not recruiting
        • Medica Plus Medical Center
  • Canada
      • Penticton, Canada
        • Completed
        • Dr. Alexander McIntyre Inc.
  • Czechia
      • Brno, Czechia
        • Active, not recruiting
        • Fakultni Nemocnice u sv. Anny v Brne
      • Hradec Kralové, Czechia
        • Active, not recruiting
        • Fakultni nemocnice Hradec Kralove
      • Hradec Kralové, Czechia
        • Active, not recruiting
        • NeuropsychiatrieHK
      • Kladno, Czechia
        • Active, not recruiting
        • Brain-Soultherapy
      • Kutna Hora, Czechia
        • Active, not recruiting
        • Námestí národního odboje 692
      • Plzen, Czechia
        • Completed
        • A-Shine s.r.o. Site #731
      • Praha, Czechia
        • Active, not recruiting
        • AD71
      • Praha, Czechia
        • Active, not recruiting
        • Clintrial
      • Praha, Czechia
        • Active, not recruiting
        • Neurologická Ambulance - Forbeli
      • Praha, Czechia
        • Active, not recruiting
        • Neuropsychiatrie
      • Rychnov nad Kněžnou, Czechia
        • Active, not recruiting
        • Vestra Clinics
  • France
      • Dijon Cedex, France
        • Active, not recruiting
        • Centre Hospitalier Universitaire Dijon Bourgogn Site #536
      • Toulouse, France
        • Active, not recruiting
        • Centre Hospitalier Universitaire Toulouse - Casselardit Ancely Site #533
    • Auvergne-Rhone-Alpes
      • Saint-Etienne, Auvergne-Rhone-Alpes, France
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord Site #535
  • Hungary
      • Balassagyarmat, Hungary
        • Completed
        • Dr. Kenessey Albert Kórház-Rendelőintézet
      • Budapest, Hungary
        • Active, not recruiting
        • Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly
      • Budapest, Hungary
        • Completed
        • Semmelweis Egyetem
      • Debrecen, Hungary
        • Completed
        • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
      • Kalocsa, Hungary, 6300
        • Active, not recruiting
        • Dr. Mathe es Tarsa Beteti Tarsasag Site #593
      • Pécs, Hungary
        • Active, not recruiting
        • PsychoTech
  • Italy
      • Roma, Italy
        • Completed
        • Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
      • Roma, Italy
        • Active, not recruiting
        • Azienda Ospedaliera Sant'Andrea
      • Roma, Italy
        • Active, not recruiting
        • Fondazione Policlinico Tor Vergata
  • Poland
      • Bydgoszcz, Poland
        • Completed
        • Ksiedza Hugona Kollataja 9
      • Katowice, Poland
        • Active, not recruiting
        • Care Clinic
      • Katowice, Poland
        • Active, not recruiting
        • Wielospecjalistyczna Poradnia Lekarska Synapsis
      • Kraków, Poland
        • Active, not recruiting
        • Krakowska Akademia Neurologii
      • Kraków, Poland
        • Active, not recruiting
        • Malopolskie Centrum Medyczne
      • Lodz, Poland
        • Active, not recruiting
        • Medycyna Milorzab
      • Poznań, Poland
        • Active, not recruiting
        • Solumed Centrum Medyczne
      • Szczecin, Poland
        • Completed
        • Centrum Medyczne Euromedis
      • Warszawa, Poland
        • Active, not recruiting
        • Centrum Medyczne NeuroProtect
      • Zabrze, Poland, 41-807
        • Active, not recruiting
        • Clinhouse Centrum Medyczne
  • South Africa
      • Cape Town, South Africa
        • Completed
        • ACF Neurological Services
      • Cape Town, South Africa
        • Active, not recruiting
        • Cape Trial Centre
      • Cape Town, South Africa
        • Terminated
        • Flexivest Fourteen Research Centre
      • Johannesburg, South Africa
        • Active, not recruiting
        • Apollo Clinical Research
      • Rosebank, South Africa
        • Active, not recruiting
        • Medical and Dental Centre
  • Spain
      • Alcobendas, Spain, 28100
        • Active, not recruiting
        • Accellacare Alcobendas
      • Barcelona, Spain
        • Completed
        • Hospital Clínic de Barcelona
      • Barcelona, Spain
        • Completed
        • Fundacio ACE
      • Elche, Spain
        • Completed
        • Hospital General Universitario de Elche
      • Madrid, Spain
        • Active, not recruiting
        • Hospital Universitario 12 de Octubre Site #657
      • Salamanca, Spain
        • Active, not recruiting
        • Hospital Universitario de Salamanca
      • Sevilla, Spain
        • Active, not recruiting
        • Hospital Universitario Virgen Macarena
      • Zamora, Spain
        • Active, not recruiting
        • Complejo Asistencial de Zamora Hospital Virgen de la Concha
      • Zaragoza, Spain
        • Active, not recruiting
        • Hospital Viamed Montecanal
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85226
        • Withdrawn
        • Brain and Spine Center
      • Chandler, Arizona, United States, 85286
        • Active, not recruiting
        • MD First Research, LLC
      • Phoenix, Arizona, United States, 85006
        • Withdrawn
        • Banner Alzheimer's Institute
      • Phoenix, Arizona, United States, 85032
        • Completed
        • NoesisPharma, LLC
      • Scottsdale, Arizona, United States, 85254
        • Completed
        • Perseverance Research Center, LLC
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Completed
        • Health Initiatives Research
    • California
      • Anaheim, California, United States, 92805
        • Active, not recruiting
        • Advanced Research Center, Inc. Site #835
      • Costa Mesa, California, United States, 92626
        • Active, not recruiting
        • ATP Clinical Research, Inc. Site #763
      • Glendale, California, United States, 91206
        • Completed
        • Behavioral Research Specialists, LLC
      • Irvine, California, United States, 92614
        • Completed
        • Irvine Center for Clinical Research
      • Irvine, California, United States, 92697
        • Withdrawn
        • University of California, Irvine
      • La Habra, California, United States, 90631
        • Withdrawn
        • Omega Clinical Trials, LLC
      • Lomita, California, United States, 90717
        • Active, not recruiting
        • Torrance Clinical Research Institute, Inc. Site #826
      • Long Beach, California, United States, 90806
        • Completed
        • Collaborative Neuroscience Network, LLC.
      • Long Beach, California, United States, 90805
        • Active, not recruiting
        • Rohun Medical Corporation Site #770
      • Long Beach, California, United States, 90807
        • Active, not recruiting
        • Alliance for Wellness, Inc dba Alliance for Research
      • Newport Beach, California, United States, 92663
        • Withdrawn
        • Shankle Clinic
      • Orange, California, United States, 92868
        • Completed
        • NRC Research Institute
      • Panorama City, California, United States, 91402
        • Completed
        • California Neurological Services
      • Pasadena, California, United States, 91105
        • Active, not recruiting
        • Havana Research Institute Site 787
      • Pasadena, California, United States, 91105
        • Completed
        • Havana Research Institute
      • San Diego, California, United States, 92103
        • Completed
        • Pacific Research Network, Inc. #1
      • San Diego, California, United States, 92103
        • Completed
        • Pacific Research Network, Inc. #2
      • San Diego, California, United States, 92103
        • Withdrawn
        • VA San Diego Healthcare System
      • Santa Ana, California, United States, 92705
        • Completed
        • Syrentis Clinical Research
      • Santa Ana, California, United States, 92704
        • Completed
        • HB Clinical Trials Inc.
      • Temecula, California, United States, 92591
        • Completed
        • Viking Clinical Research
      • Tustin, California, United States, 92780
        • Withdrawn
        • New Foundation Medical Group Clinical Trials
    • Colorado
      • Denver, Colorado, United States, 80209
        • Completed
        • Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Withdrawn
        • Connecticut Clinical Research
      • Danbury, Connecticut, United States, 06810
        • Withdrawn
        • Associated Neurologists, PC
      • Hamden, Connecticut, United States, 06518
        • Withdrawn
        • Geriatric and Adult Psychiatry LLC
      • New London, Connecticut, United States, 06320
        • Completed
        • Coastal Connecticut Research, LLC
      • Norwalk, Connecticut, United States, 06851
        • Completed
        • Research Center for Clinical Studies, Inc.
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Active, not recruiting
        • Neurology of Central Florida Rsch Ctr Site #803
      • Atlantis, Florida, United States, 33462
        • Completed
        • JEM Research Institute
      • Aventura, Florida, United States, 33180
        • Active, not recruiting
        • Negron Research Services / Humanity Clinical Research Site# 766
      • Boca Raton, Florida, United States, 33428
        • Withdrawn
        • Neurology Offices of South Florida
      • Boca Raton, Florida, United States, 33487
        • Active, not recruiting
        • SFM Clinical Research, LLC Site #563
      • Bradenton, Florida, United States, 34205
        • Active, not recruiting
        • Bradenton Research Center Site #834
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Clinical Research of Brandon
      • Brandon, Florida, United States, 33511
        • Active, not recruiting
        • Clinical Research Of Brandon, LLC Site #838
      • Brooksville, Florida, United States, 34601
        • Completed
        • Meridien Research
      • Deerfield Beach, Florida, United States, 33064
        • Completed
        • Quantum Laboratories, Inc.
      • Doral, Florida, United States, 33166
        • Completed
        • Moonshine Research Center, Inc
      • Doral, Florida, United States, 33178
        • Active, not recruiting
        • Science Connections, LLC Site #814
      • Gainesville, Florida, United States, 32607
        • Withdrawn
        • University of Florida
      • Greenacres City, Florida, United States, 33467
        • Completed
        • Finlay Medical Research Corp
      • Hialeah, Florida, United States, 33016
        • Completed
        • Galiz Research
      • Hialeah, Florida, United States, 33012
        • Withdrawn
        • Direct Helpers Research Center
      • Hialeah, Florida, United States, 33012
        • Completed
        • Indago Research & Health Center, Inc.
      • Hialeah, Florida, United States, 33012
        • Completed
        • New Life Medical Research Center, Inc.
      • Hialeah, Florida, United States, 33012
        • Completed
        • Reliable Clinical Research,LLC
      • Hialeah, Florida, United States, 33013
        • Completed
        • Research in Miami, Inc
      • Hialeah, Florida, United States, 33013
        • Completed
        • The Research Center, Inc
      • Hialeah, Florida, United States, 33016
        • Completed
        • Berma Research Group
      • Hialeah, Florida, United States, 33018
        • Completed
        • Maxblue Institute
      • Hialeah, Florida, United States, 33012
        • Active, not recruiting
        • ConSalud Medical Research Site #773
      • Hialeah, Florida, United States, 33012
        • Active, not recruiting
        • Direct Helpers Research Center #801
      • Hollywood, Florida, United States, 33020
        • Active, not recruiting
        • New Med Research, Inc Site #812
      • Jacksonville, Florida, United States, 32256
        • Completed
        • Clinical Neuroscience Solutions, Inc.
      • Kissimmee, Florida, United States, 34741
        • Completed
        • SIH Research, LLC
      • Lake Worth, Florida, United States, 33449
        • Completed
        • Alzheimer's Research and Treatment Center #1
      • Lake Worth, Florida, United States, 33449
        • Completed
        • Alzheimer's Research and Treatment Center #2
      • Lake Worth, Florida, United States, 33449
        • Completed
        • Alzheimer's Research and Treatment Center #3
      • Lakeland, Florida, United States, 33803
        • Completed
        • Meridien Research Site #558
      • Lauderhill, Florida, United States, 33319
        • Active, not recruiting
        • Innovative Clinical Research, Inc. Site #819
      • Miami, Florida, United States, 33136
        • Completed
        • University of Miami
      • Miami, Florida, United States, 33122
        • Completed
        • Premier Clinical Research Institute, Inc. #1
      • Miami, Florida, United States, 33122
        • Completed
        • Premier Clinical Research Institute, Inc. #2
      • Miami, Florida, United States, 33125
        • Completed
        • Global Medical Institutes, LLC
      • Miami, Florida, United States, 33125
        • Completed
        • Optimus U Corp
      • Miami, Florida, United States, 33125
        • Completed
        • Project 4 Research #1
      • Miami, Florida, United States, 33125
        • Completed
        • Project 4 Research #2
      • Miami, Florida, United States, 33126
        • Completed
        • BioMed Research Institute
      • Miami, Florida, United States, 33133
        • Completed
        • CCM Clinical Research Group
      • Miami, Florida, United States, 33133
        • Completed
        • Innova Clinical Trials
      • Miami, Florida, United States, 33135
        • Completed
        • Advance Medical Research Center #1
      • Miami, Florida, United States, 33135
        • Completed
        • Advance Medical Research Center #2
      • Miami, Florida, United States, 33135
        • Completed
        • Dade Research Center Llc
      • Miami, Florida, United States, 33135
        • Completed
        • Vitae Researrch Center LLC
      • Miami, Florida, United States, 33137
        • Completed
        • Miami Jewish Health Systems, Inc.
      • Miami, Florida, United States, 33144
        • Withdrawn
        • AMB Research Center, Inc.
      • Miami, Florida, United States, 33144
        • Completed
        • United Health Research Corp. #1
      • Miami, Florida, United States, 33144
        • Completed
        • United Health Research Corp. #2
      • Miami, Florida, United States, 33145
        • Terminated
        • Advanced Medical Center Group
      • Miami, Florida, United States, 33165
        • Completed
        • Future Care Solution, LLC
      • Miami, Florida, United States, 33172
        • Completed
        • Clinical Research Associates of South Florida #1
      • Miami, Florida, United States, 33172
        • Terminated
        • Clinical Research Associates of South Florida #2
      • Miami, Florida, United States, 33175
        • Completed
        • Coral Research Clinic Corp
      • Miami, Florida, United States, 33176
        • Withdrawn
        • Miami Dade Medical Research Institute, LLC
      • Miami, Florida, United States, 33176
        • Withdrawn
        • The Neurology Research Group, LLC
      • Miami, Florida, United States, 33183
        • Withdrawn
        • International Research Associates, LLC
      • Miami, Florida, United States, 33183
        • Completed
        • Kendall Research Institute
      • Miami, Florida, United States, 33186
        • Completed
        • Nuovida Research Center Corp.
      • Miami, Florida, United States, 33186
        • Withdrawn
        • Research Institute of West Kendall
      • Miami, Florida, United States, 33032
        • Active, not recruiting
        • Homestead Associates in Research Site# 797
      • Miami, Florida, United States, 33125
        • Active, not recruiting
        • Central Miami Medical Institute
      • Miami, Florida, United States, 33126
        • Active, not recruiting
        • Finlay Medical Research Corp Site #552
      • Miami, Florida, United States, 33126
        • Active, not recruiting
        • First Class Medical Services Site #807
      • Miami, Florida, United States, 33165
        • Active, not recruiting
        • Reliant Medical Research LLC Site #811
      • Miami, Florida, United States, 33175
        • Active, not recruiting
        • P&S RESEARCH, LLC. Site #805
      • Miami, Florida, United States, 33175
        • Active, not recruiting
        • Pharmax Research of South Florida
      • Miami Lakes, Florida, United States, 33016
        • Withdrawn
        • Agility Clinical Research, Inc.
      • Naples, Florida, United States, 34102
        • Completed
        • Collier Neurologic Specialists, LLC
      • Naples, Florida, United States, 34102
        • Terminated
        • Naples Research, Inc
      • New Port Richey, Florida, United States, 34655
        • Active, not recruiting
        • Bayside Clinical Research Site #556
      • North Palm Beach, Florida, United States, 33408
        • Withdrawn
        • Lazlo J. Mate, MD, PA
      • Oakland Park, Florida, United States, 33334
        • Completed
        • Research Centers of America, LLC
      • Ocoee, Florida, United States, 34761
        • Withdrawn
        • Sensible Healthcare
      • Orlando, Florida, United States, 32806
        • Completed
        • Compass Research, LLC
      • Orlando, Florida, United States, 32807
        • Active, not recruiting
        • Combined Research Orlando Site #799
      • Ormond Beach, Florida, United States, 32174
        • Completed
        • Neurology Associates of Ormond Beach
      • Palmetto Bay, Florida, United States, 03157
        • Completed
        • Innovation Medical Research Center
      • Palmetto Bay, Florida, United States, 33157
        • Completed
        • IMIC Inc.
      • Palmetto Bay, Florida, United States, 33157
        • Active, not recruiting
        • Innovation Medical Research Center Site #802
      • Pensacola, Florida, United States, 32514
        • Completed
        • University of West Florida
      • Port Charlotte, Florida, United States, 33952
        • Active, not recruiting
        • Neurostudies Inc. Site#796
      • Saint Petersburg, Florida, United States, 33713
        • Withdrawn
        • Suncoast Neuroscience Associates, Inc.
      • Sarasota, Florida, United States, 34243
        • Completed
        • Roskamp Institute
      • Tampa, Florida, United States, 33609
        • Completed
        • Olympian Clinical Research
      • Tampa, Florida, United States, 33613
        • Withdrawn
        • University of South Florida
      • Tampa, Florida, United States, 33615
        • Active, not recruiting
        • VICIS Clinical Research Inc.
      • The Villages, Florida, United States, 32162
        • Completed
        • Compass Research North, LLC
      • West Palm Beach, Florida, United States, 33407
        • Completed
        • Neurology Research Institute Palm Beach, LLC #1
      • West Palm Beach, Florida, United States, 33407
        • Completed
        • Neurology Research Institute Palm Beach, LLC #2
      • Winter Park, Florida, United States, 32789
        • Completed
        • Florida Premier Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Withdrawn
        • Emory Brain Health Center
      • Atlanta, Georgia, United States, 30342
        • Completed
        • NeuroTrials Research Inc
      • Columbus, Georgia, United States, 31904
        • Completed
        • Columbus Research & Wellness Institute, INC
      • Columbus, Georgia, United States, 31909
        • Completed
        • Medical Research & Health Education Foundation, Inc.
      • Decatur, Georgia, United States, 30033
        • Completed
        • NeuroStudies. Net, LLC
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Withdrawn
        • Alexian Brothers Neurosciences Institute
      • Schaumburg, Illinois, United States, 60194
        • Withdrawn
        • Behavioral Health Care Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Completed
        • Indiana University School of Medicine
      • Indianapolis, Indiana, United States, 46256
        • Completed
        • Josephson Wallack Munshower Neurology, PC
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • Completed
        • MidAmerica Neuroscience Research Foundation
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Completed
        • Four Rivers Clinical Research Inc.
    • Louisiana
      • Shreveport, Louisiana, United States, 71104
        • Withdrawn
        • J. Gary Booker, MD, APMC
    • Maryland
      • Easton, Maryland, United States, 21601
        • Completed
        • The Samuel & Alexia Bratton Memory Clinic
      • Hagerstown, Maryland, United States, 21742
        • Completed
        • Mir Neurology
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730
        • Withdrawn
        • Bedford VA Hospital
      • Braintree, Massachusetts, United States, 02184
        • Active, not recruiting
        • Alzheimer Disease Center Site #804
      • Newton, Massachusetts, United States, 02459
        • Completed
        • Boston Center for Memory
      • Quincy, Massachusetts, United States, 02169
        • Completed
        • Alzheimer's Disease Center
    • Michigan
      • Caro, Michigan, United States, 48723
        • Terminated
        • Onyx Clinical Research, LLC
      • East Lansing, Michigan, United States, 48824
        • Completed
        • Michigan State University Department of Neurology
      • Paw Paw, Michigan, United States, 49079
        • Withdrawn
        • Bronson Neurobehavioral Health
      • Troy, Michigan, United States, 48085
        • Active, not recruiting
        • Oakland Medical Research Site #762
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Terminated
        • Galen Research
      • Creve Coeur, Missouri, United States, 63141
        • Completed
        • Millennium Psychiatric Associates, LLC
      • Kansas City, Missouri, United States, 64111
        • Withdrawn
        • Saint Luke'S Hospital of Kansas City
      • Saint Louis, Missouri, United States, 63128
        • Withdrawn
        • PsychCare Consultants Research
      • Saint Louis, Missouri, United States, 63141
        • Withdrawn
        • Clinical Research Professionals
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Withdrawn
        • Geriatric Solutions, LLC
    • New Jersey
      • Marmora, New Jersey, United States, 08223
        • Withdrawn
        • Flora Baker Center for Alzheimer's Disease and Related Disorders
      • Mount Arlington, New Jersey, United States, 07856
        • Completed
        • The NeuroCognitive Institute
      • Toms River, New Jersey, United States, 08755
        • Completed
        • Bio Behavioral Health
    • New York
      • Amherst, New York, United States, 14226
        • Completed
        • Dent Neurologic Institute
      • Brooklyn, New York, United States, 11214
        • Withdrawn
        • Brooklyn Medical Institute
      • Brooklyn, New York, United States, 11229
        • Completed
        • Integrative Clinical Trials LLC #1
      • Brooklyn, New York, United States, 11229
        • Completed
        • Integrative Clinical Trials LLC #2
      • New York, New York, United States, 10032
        • Completed
        • Columbia University Medical Center
      • New York, New York, United States, 10036
        • Completed
        • Manhattan Behavioral Medicine, PLLC
      • New York, New York, United States, 10128
        • Completed
        • Eastside Comprehensive Medical Center, LLC
      • Orangeburg, New York, United States, 10962
        • Completed
        • Nathan S. Kline Institute for Psychiatric Research #1
      • Orangeburg, New York, United States, 10962
        • Completed
        • Nathan S. Kline Institute for Psychiatric Research #571
      • Rochester, New York, United States, 14620
        • Completed
        • University of Rochester Medical Center
      • Rochester, New York, United States, 14623
        • Withdrawn
        • Psychiatry and Alzheimer's Care of Rochester, PLLC
      • Staten Island, New York, United States, 10312
        • Completed
        • Richmond Behavioral Associates
      • White Plains, New York, United States, 10605
        • Completed
        • Burke Rehabilitation Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Completed
        • Herbert Harris, Md, Phd, Pa
      • Charlotte, North Carolina, United States, 28270
        • Completed
        • ANI Neurology PLLC dba Alzheimer's Memory Center
      • Durham, North Carolina, United States, 27710
        • Completed
        • Duke University Medical Center
    • Ohio
      • Akron, Ohio, United States, 44313
        • Withdrawn
        • Daystar Clinical Research Inc
      • Akron, Ohio, United States, 44320
        • Completed
        • Neurology and Neuroscience Associates, Inc.
      • Beachwood, Ohio, United States, 44122
        • Active, not recruiting
        • Insight Clinical Trials, LLC Site #570
      • Bellevue, Ohio, United States, 44811
        • Withdrawn
        • Insight Neuroscience, LLC
      • Centerville, Ohio, United States, 45459
        • Completed
        • Valley Medical Research
      • Centerville, Ohio, United States, 45459
        • Terminated
        • Valley Medical Research Site #788
      • Cincinnati, Ohio, United States, 45212
        • Withdrawn
        • CTI Clinical Research Center
      • Cincinnati, Ohio, United States, 45219
        • Completed
        • University of Cincinnati
      • Columbus, Ohio, United States, 43210
        • Completed
        • The Ohio State University
      • Lakewood, Ohio, United States, 44107
        • Completed
        • Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital
      • Middleburg Heights, Ohio, United States, 44130
        • Active, not recruiting
        • NorthStar Medical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Completed
        • IPS Research Company
      • Oklahoma City, Oklahoma, United States, 73112
        • Completed
        • Oklahoma Clinical Research Center
      • Tulsa, Oklahoma, United States, 74104
        • Withdrawn
        • Tulsa Clinical Research, LLC
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Completed
        • Heritage Valley Medical Group, Inc.
      • Levittown, Pennsylvania, United States, 19056
        • Withdrawn
        • The Birches at Newton / Family Medical Associates
      • Philadelphia, Pennsylvania, United States, 19107
        • Withdrawn
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19107
        • Withdrawn
        • Drexel University
      • Willow Grove, Pennsylvania, United States, 19090
        • Completed
        • Abington Neurological Associates, LTD
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Completed
        • Rhode Island Mood & Memory Research Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Completed
        • RH Johnson VA Medical Center
      • Charleston, South Carolina, United States, 29401
        • Completed
        • Roper St. Francis Healthcare
      • Port Royal, South Carolina, United States, 29935
        • Withdrawn
        • Coastal Neurology, PA
      • Spartanburg, South Carolina, United States, 29307
        • Completed
        • BG Neurology
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Withdrawn
        • Neurology Clinic, P.C.
      • Franklin, Tennessee, United States, 37064
        • Withdrawn
        • Clinical Research Solutions
    • Texas
      • Dallas, Texas, United States, 75214
        • Completed
        • Texas Neurology, P.A.
      • Dallas, Texas, United States, 75231
        • Completed
        • Neurology Consultants of Dallas, PA
      • Dallas, Texas, United States, 75390-8898
        • Completed
        • University Texas Southwestern Medical Center
      • DeSoto, Texas, United States, 75115
        • Completed
        • InSite Clinical Research Site #576
      • Houston, Texas, United States, 77030
        • Completed
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Completed
        • Houston Methodist Neurological Institute
      • Irving, Texas, United States, 75062
        • Withdrawn
        • University Hills Clinical Research
      • Mansfield, Texas, United States, 76063
        • Withdrawn
        • Neurology Associates of Arlington
      • McKinney, Texas, United States, 75071
        • Withdrawn
        • Wellness Clinical Research Site #824
      • Mesquite, Texas, United States, 75149
        • Active, not recruiting
        • PRX Research Site #825
      • San Antonio, Texas, United States, 78238
        • Completed
        • Texas Medical Research Associates, L.L.C.
    • Utah
      • Clinton, Utah, United States, 84015
        • Completed
        • Ericksen Research and Development
      • Salt Lake City, Utah, United States, 84107
        • Completed
        • Pharmaceuticals Research Associates, Inc.
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Completed
        • Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic
      • Woodstock, Vermont, United States, 05091
        • Completed
        • Neuropsychiatric Associates
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Withdrawn
        • Sentara Neurosciences Institute
      • Salem, Virginia, United States, 24153
        • Completed
        • Veteran Affairs Medical Center, Salem Virginia
    • Washington
      • Bellevue, Washington, United States, 98007
        • Completed
        • Northwest Clinical Research Center
      • Everett, Washington, United States, 98201
        • Active, not recruiting
        • Core Clinical Research Site #772
      • Spokane, Washington, United States, 99204
        • Withdrawn
        • Frontier Institute
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Completed
        • IPC Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
  • Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
  • Either out-patients or residents of an assisted-living facility or a skilled nursing home
  • Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
  • Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
  • Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
  • Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline

Exclusion Criteria:

  • 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 determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
  • Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVP-786 (dose 1)
AVP-786 dose 1; capsules administered twice a day over a 52-week period
Drug: AVP-786
Experimental: AVP-786 (dose 2)
AVP-786 dose 2; capsules administered twice a day over a 52-week period
Drug: AVP-786
Experimental: AVP-786 (dose 3)
AVP-786 dose 3; capsules administered twice a day over a 52-week period
Drug: AVP-786

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with any Treatment-Emergent Adverse Event
Time Frame: up to 64 weeks
up to 64 weeks
Number of Participants with any Treatment-Emergent Serious Adverse Event
Time Frame: up to 64 weeks
up to 64 weeks
Number of Participants with any abnormal, clinically significant Clinical Laboratory Value
Time Frame: up to 52 weeks
up to 52 weeks
Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value
Time Frame: up to 52 weeks
up to 52 weeks
Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding
Time Frame: up to 52 weeks
up to 52 weeks
Number of participants with any abnormal, clinically significant vital sign value
Time Frame: up to 52 weeks
up to 52 weeks
Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score
Time Frame: Baseline; Week 64
Baseline; Week 64
Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score
Time Frame: Baseline; Week 52
Baseline; Week 52
Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score
Time Frame: Baseline; Week 52
Baseline; Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Time Frame: Baseline; Week 64
Baseline; Week 64
Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI)
Time Frame: Baseline; Week 52
Baseline; Week 52
Change from Baseline to Week 64 in the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score
Time Frame: Baseline; Week 64
Baseline; Week 64
Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score
Time Frame: Baseline; Week 52
Baseline; Week 52
Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score
Time Frame: Baseline; Week 52
PGIC (rated by caregiver)
Baseline; Week 52
Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score
Time Frame: Baseline; Week 52
Baseline; Week 52
Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score
Time Frame: Baseline; Week 52
Baseline; Week 52
Change from Baseline to Week 52 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants from Study 17-AVP-786-305
Time Frame: Baseline; Week 52
Baseline; Week 52

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants using concomitant medications
Time Frame: up to 64 weeks
up to 64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimated)

May 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-AVP-786-303
  • 2017-002455-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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