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
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type
- Interventions
- Registration Number
- NCT02446132
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1197
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AVP-786 (dose 2) AVP-786 AVP-786 dose 2; capsules administered twice a day over a 52-week period AVP-786 (dose 1) AVP-786 AVP-786 dose 1; capsules administered twice a day over a 52-week period AVP-786 (dose 3) AVP-786 AVP-786 dose 3; capsules administered twice a day over a 52-week period
- Primary Outcome Measures
Name Time Method Number of Participants with any Treatment-Emergent Serious Adverse Event up to 64 weeks Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding up to 52 weeks Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value up to 52 weeks Number of Participants with any Treatment-Emergent Adverse Event up to 64 weeks Number of participants with any abnormal, clinically significant vital sign value up to 52 weeks Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score Baseline; Week 64 Number of Participants with any abnormal, clinically significant Clinical Laboratory Value up to 52 weeks Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score Baseline; Week 52 Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score Baseline; Week 52
- Secondary Outcome Measures
Name Time Method Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score 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) Baseline; Week 52 Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score 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 Baseline; Week 64 Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score Baseline; Week 52 PGIC (rated by caregiver)
Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score Baseline; Week 52 Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score 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 Baseline; Week 52
Trial Locations
- Locations (227)
Collier Neurologic Specialists, LLC
🇺🇸Naples, Florida, United States
Naples Research, Inc
🇺🇸Naples, Florida, United States
Bayside Clinical Research Site #556
🇺🇸New Port Richey, Florida, United States
Columbus Research & Wellness Institute, INC
🇺🇸Columbus, Georgia, United States
Medical Research & Health Education Foundation, Inc.
🇺🇸Columbus, Georgia, United States
NeuroStudies. Net, LLC
🇺🇸Decatur, Georgia, United States
Alzheimer's Disease Center
🇺🇸Quincy, Massachusetts, United States
Millennium Psychiatric Associates, LLC
🇺🇸Creve Coeur, Missouri, United States
The NeuroCognitive Institute
🇺🇸Mount Arlington, New Jersey, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Integrative Clinical Trials LLC #1
🇺🇸Brooklyn, New York, United States
Integrative Clinical Trials LLC #2
🇺🇸Brooklyn, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Havana Research Institute
🇺🇸Pasadena, California, United States
Pacific Research Network, Inc. #1
🇺🇸San Diego, California, United States
Pacific Research Network, Inc. #2
🇺🇸San Diego, California, United States
HB Clinical Trials Inc.
🇺🇸Santa Ana, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Viking Clinical Research
🇺🇸Temecula, California, United States
Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
🇺🇸Denver, Colorado, United States
Coastal Connecticut Research, LLC
🇺🇸New London, Connecticut, United States
Alzheimer's Research and Treatment Center #2
🇺🇸Lake Worth, Florida, United States
Alzheimer's Research and Treatment Center #3
🇺🇸Lake Worth, Florida, United States
Meridien Research Site #558
🇺🇸Lakeland, Florida, United States
Innovative Clinical Research, Inc. Site #819
🇺🇸Lauderhill, Florida, United States
New Med Research, Inc Site #812
🇺🇸Miami Gardens, Florida, United States
Homestead Associates in Research Site# 797
🇺🇸Miami, Florida, United States
Premier Clinical Research Institute, Inc. #1
🇺🇸Miami, Florida, United States
Premier Clinical Research Institute, Inc. #2
🇺🇸Miami, Florida, United States
Global Medical Institutes, LLC
🇺🇸Miami, Florida, United States
Optimus U Corp
🇺🇸Miami, Florida, United States
Project 4 Research #1
🇺🇸Miami, Florida, United States
Project 4 Research #2
🇺🇸Miami, Florida, United States
BioMed Research Institute
🇺🇸Miami, Florida, United States
Finlay Medical Research Corp Site #552
🇺🇸Miami, Florida, United States
First Class Medical Services Site #807
🇺🇸Miami, Florida, United States
CCM Clinical Research Group
🇺🇸Miami, Florida, United States
Innova Clinical Trials
🇺🇸Miami, Florida, United States
Advance Medical Research Center #1
🇺🇸Miami, Florida, United States
Advance Medical Research Center #2
🇺🇸Miami, Florida, United States
Dade Research Center Llc
🇺🇸Miami, Florida, United States
Vitae Researrch Center LLC
🇺🇸Miami, Florida, United States
Roper St. Francis Healthcare
🇺🇸Charleston, South Carolina, United States
BG Neurology
🇺🇸Spartanburg, South Carolina, United States
Texas Neurology, P.A.
🇺🇸Dallas, Texas, United States
Neurology Consultants of Dallas, PA
🇺🇸Dallas, Texas, United States
University Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
InSite Clinical Research Site #576
🇺🇸DeSoto, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Houston Methodist Neurological Institute
🇺🇸Houston, Texas, United States
PRX Research Site #825
🇺🇸Mesquite, Texas, United States
Texas Medical Research Associates, L.L.C.
🇺🇸San Antonio, Texas, United States
Ericksen Research and Development
🇺🇸Clinton, Utah, United States
Pharmaceuticals Research Associates, Inc.
🇺🇸Salt Lake City, Utah, United States
Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
🇮🇹Roma, Italy
Ksiedza Hugona Kollataja 9
🇵🇱Bydgoszcz, Poland
Care Clinic Clinical Research Site #750
🇵🇱Katowice, Poland
Wielospecjalistyczna Poradnia Lekarska Synapsis Site #741
🇵🇱Katowice, Poland
Krakowska Akademia Neurologii Site #740
🇵🇱Kraków, Poland
Malopolskie Centrum Medyczne Site #747
🇵🇱Kraków, Poland
Medycyna Milorzab Site #743
🇵🇱Lodz, Poland
Solumed Centrum Medyczne Site #753
🇵🇱Poznań, Poland
Centrum Medyczne Euromedis
🇵🇱Szczecin, Poland
Centrum Medyczne NeuroProtect Site #742
🇵🇱Warszawa, Poland
ClinHouse Centrum Medyczne
🇵🇱Zabrze, Poland
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
🇭🇺Debrecen, Hungary
Dr. Mathe es Tarsa Beteti Tarsasag Site #593
🇭🇺Kalocsa, Hungary
Galen Research
🇺🇸Chesterfield, Missouri, United States
PsychoTech Clinical Research Site# 580
🇭🇺Pécs, Hungary
Azienda Ospedaliera Sant'Andrea Site #606
🇮🇹Roma, Italy
Fondazione Policlinico Tor Vergata Site #609
🇮🇹Roma, Italy
Medical and Dental Centre
🇿🇦Rosebank, South Africa
MD First Research, LLC Site #767
🇺🇸Chandler, Arizona, United States
Alliance for Wellness, Inc dba Alliance for Research Site #789
🇺🇸Long Beach, California, United States
Central Miami Medical Institute Site #798
🇺🇸Miami, Florida, United States
VICIS Clinical Research Inc. Site #777
🇺🇸Tampa, Florida, United States
Twoja Przychodnia - Centrum Medyczne Nowa Sol Site #757
🇵🇱Nowa Sól, Lubuskie, Poland
RCMed Oddział Sochaczew Site #510
🇵🇱Sochaczew, Mazowieckie, Poland
NoesisPharma, LLC
🇺🇸Phoenix, Arizona, United States
Perseverance Research Center, LLC
🇺🇸Scottsdale, Arizona, United States
Health Initiatives Research
🇺🇸Fayetteville, Arkansas, United States
Advanced Research Center, Inc. Site #835
🇺🇸Anaheim, California, United States
ATP Clinical Research, Inc. Site #763
🇺🇸Costa Mesa, California, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Irvine Center for Clinical Research
🇺🇸Irvine, California, United States
Sheenath Clinical Service Site #770
🇺🇸Lakewood, California, United States
Torrance Clinical Research Institute, Inc. Site #826
🇺🇸Lomita, California, United States
Collaborative Neuroscience Network, LLC.
🇺🇸Long Beach, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
California Neurological Services
🇺🇸Panorama City, California, United States
Havana Research Institute Site 787
🇺🇸Pasadena, California, United States
Research Center for Clinical Studies, Inc.
🇺🇸Norwalk, Connecticut, United States
Neurology of Central Florida Rsch Ctr Site #803
🇺🇸Altamonte Springs, Florida, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Negron Research Services / Humanity Clinical Research Site# 766
🇺🇸Aventura, Florida, United States
SFM Clinical Research, LLC Site #563
🇺🇸Boca Raton, Florida, United States
Bradenton Research Center Site #834
🇺🇸Bradenton, Florida, United States
Clinical Research Of Brandon, LLC Site #838
🇺🇸Brandon, Florida, United States
Clinical Research of Brandon
🇺🇸Brandon, Florida, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Quantum Laboratories, Inc.
🇺🇸Deerfield Beach, Florida, United States
Moonshine Research Center, Inc
🇺🇸Doral, Florida, United States
Science Connections, LLC Site #814
🇺🇸Doral, Florida, United States
Finlay Medical Research Corp
🇺🇸Greenacres City, Florida, United States
Direct Helpers Research Center #801
🇺🇸Hialeah, Florida, United States
Indago Research & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
New Life Medical Research Center, Inc.
🇺🇸Hialeah, Florida, United States
Reliable Clinical Research,LLC
🇺🇸Hialeah, Florida, United States
Research in Miami, Inc
🇺🇸Hialeah, Florida, United States
The Research Center, Inc
🇺🇸Hialeah, Florida, United States
Berma Research Group
🇺🇸Hialeah, Florida, United States
Galiz Research
🇺🇸Hialeah, Florida, United States
Maxblue Institute
🇺🇸Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Alphab Global Research #793
🇺🇸Jupiter, Florida, United States
SIH Research, LLC
🇺🇸Kissimmee, Florida, United States
Alzheimer's Research and Treatment Center #1
🇺🇸Lake Worth, Florida, United States
Oakland Medical Research Site #762
🇺🇸Troy, Michigan, United States
University of Miami
🇺🇸Miami, Florida, United States
Miami Jewish Health Systems, Inc.
🇺🇸Miami, Florida, United States
United Health Research Corp. #1
🇺🇸Miami, Florida, United States
United Health Research Corp. #2
🇺🇸Miami, Florida, United States
Advanced Medical Center Group
🇺🇸Miami, Florida, United States
Future Care Solution, LLC
🇺🇸Miami, Florida, United States
Reliant Medical Research LLC Site #811
🇺🇸Miami, Florida, United States
Hope Research Network LLC Site #773
🇺🇸Miami, Florida, United States
Clinical Research Associates of South Florida #1
🇺🇸Miami, Florida, United States
Clinical Research Associates of South Florida #2
🇺🇸Miami, Florida, United States
Coral Research Clinic Corp
🇺🇸Miami, Florida, United States
P&S RESEARCH, LLC. Site #805
🇺🇸Miami, Florida, United States
Pharmax Research of South Florida
🇺🇸Miami, Florida, United States
Kendall Research Institute
🇺🇸Miami, Florida, United States
Nuovida Research Center Corp.
🇺🇸Miami, Florida, United States
Accellacare Alcobendas
🇪🇸Alcobendas, Spain
Research Centers of America, LLC
🇺🇸Oakland Park, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Combined Research Orlando Site #799
🇺🇸Orlando, Florida, United States
Neurology Associates of Ormond Beach
🇺🇸Ormond Beach, Florida, United States
Innovation Medical Research Center
🇺🇸Palmetto Bay, Florida, United States
IMIC Inc.
🇺🇸Palmetto Bay, Florida, United States
Innovation Medical Research Center Site #802
🇺🇸Palmetto Bay, Florida, United States
Fundació ACE
🇪🇸Barcelona, Spain
University of West Florida
🇺🇸Pensacola, Florida, United States
Neurostudies Inc. Site#796
🇺🇸Port Charlotte, Florida, United States
Roskamp Institute
🇺🇸Sarasota, Florida, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
Compass Research North, LLC
🇺🇸The Villages, Florida, United States
Neurology Research Institute Palm Beach, LLC #1
🇺🇸West Palm Beach, Florida, United States
Neurology Research Institute Palm Beach, LLC #2
🇺🇸West Palm Beach, Florida, United States
Florida Premier Research Institute
🇺🇸Winter Park, Florida, United States
NeuroTrials Research Inc
🇺🇸Atlanta, Georgia, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Josephson Wallack Munshower Neurology, PC
🇺🇸Indianapolis, Indiana, United States
MidAmerica Neuroscience Research Foundation
🇺🇸Lenexa, Kansas, United States
Four Rivers Clinical Research Inc.
🇺🇸Paducah, Kentucky, United States
The Samuel & Alexia Bratton Memory Clinic
🇺🇸Easton, Maryland, United States
Mir Neurology
🇺🇸Hagerstown, Maryland, United States
Alzheimer Disease Center Site #804
🇺🇸Braintree, Massachusetts, United States
Boston Center for Memory
🇺🇸Newton, Massachusetts, United States
Onyx Clinical Research, LLC
🇺🇸Caro, Michigan, United States
Michigan State University Department of Neurology
🇺🇸East Lansing, Michigan, United States
Manhattan Behavioral Medicine, PLLC
🇺🇸New York, New York, United States
Eastside Comprehensive Medical Center, LLC
🇺🇸New York, New York, United States
Nathan S. Kline Institute for Psychiatric Research #1
🇺🇸Orangeburg, New York, United States
Nathan S. Kline Institute for Psychiatric Research #571
🇺🇸Orangeburg, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Burke Rehabilitation Hospital
🇺🇸White Plains, New York, United States
Herbert Harris, Md, Phd, Pa
🇺🇸Chapel Hill, North Carolina, United States
ANI Neurology PLLC dba Alzheimer's Memory Center
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Neurology and Neuroscience Associates, Inc.
🇺🇸Akron, Ohio, United States
Insight Clinical Trials, LLC Site #570
🇺🇸Beachwood, Ohio, United States
Valley Medical Research Site #788
🇺🇸Centerville, Ohio, United States
Valley Medical Research
🇺🇸Centerville, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital
🇺🇸Lakewood, Ohio, United States
NorthStar Medical Research Site #778
🇺🇸Middleburg Heights, Ohio, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Heritage Valley Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
Abington Neurological Associates, LTD
🇺🇸Willow Grove, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
RH Johnson VA Medical Center
🇺🇸Charleston, South Carolina, United States
Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic
🇺🇸Bennington, Vermont, United States
Neuropsychiatric Associates
🇺🇸Woodstock, Vermont, United States
Veteran Affairs Medical Center, Salem Virginia
🇺🇸Salem, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Core Clinical Research Site #772
🇺🇸Everett, Washington, United States
IPC Research
🇺🇸Waukesha, Wisconsin, United States
Center for Mental Health - Ruse
🇧🇬Ruse, Bulgaria
Mental Health Centre Prof. Nikola Shipkovenski Site #713
🇧🇬Sofia, Bulgaria
Medical Center Sveti Naum Site #707
🇧🇬Sofia, Bulgaria
Vrach and Sv. Sv. Kuzma and Damian Site #710
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska Site #704
🇧🇬Sofia, Bulgaria
Medical Center Mladost-M
🇧🇬Varna, Bulgaria
Medica Plus Medical Center
🇧🇬Veliko Tarnovo, Bulgaria
Dr. Alexander McIntyre Inc.
🇨🇦Penticton, Canada
Fakultni Nemocnice u sv. Anny v Brne Site #722
🇨🇿Brno, Czechia
Fakultní Nemocnice Hradec Králové Site #724
🇨🇿Hradec Kralové, Czechia
NeuropsychiatrieHK Site #729
🇨🇿Hradec Kralové, Czechia
Brain-Soultherapy
🇨🇿Kladno, Czechia
Námestí národního odboje 692 Site #723
🇨🇿Kutna Hora, Czechia
A-Shine s.r.o. Site #731
🇨🇿Plzen, Czechia
AD71
🇨🇿Praha, Czechia
Clintrial
🇨🇿Praha, Czechia
Neurologicka Ambulance - Forbeli
🇨🇿Praha, Czechia
Neuropsychiatrie Site #726
🇨🇿Praha, Czechia
Vestra Clinics
🇨🇿Rychnov nad Kněžnou, Czechia
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord Site #535
🇫🇷Saint-Etienne, Auvergne-Rhone-Alpes, France
Centre Hospitalier Universitaire Dijon Bourgogn Site #536
🇫🇷Dijon Cedex, France
Centre Hospitalier Universitaire Toulouse - Casselardit Ancely Site #533
🇫🇷Toulouse, France
Dr. Kenessey Albert Kórház-Rendelőintézet
🇭🇺Balassagyarmat, Hungary
Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly Site #586
🇭🇺Budapest, Hungary
ACF Neurological Services
🇿🇦Cape Town, South Africa
Cape Trial Centre
🇿🇦Cape Town, South Africa
Flexivest Fourteen Research Centre
🇿🇦Cape Town, South Africa
Apollo Clinical Research Site #623
🇿🇦Johannesburg, South Africa
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Virgen Macarena Site #649
🇪🇸Sevilla, Spain
Complejo Asistencial de Zamora Hospital Virgen de la Concha
🇪🇸Zamora, Spain
Hospital Viamed Montecanal Site #643
🇪🇸Zaragoza, Spain