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AzTrials

Agitation in Patients With Dementia of the Alzheimer's TypePhase 3NCT02446132

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

A Phase 3 study testing AVP-786 in people with Agitation in Patients With Dementia of the Alzheimer's Type, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 227 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305. Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
AVP-786
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,197 participants
Where
227 sitesin 10 countries
Study dates
13 Nov 2015to 6 Sep 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

227 sites in 10 countries.

227 sites in 10 countries

United States171 sites

  • Neurology and Neuroscience Associates, Inc.

    Akron, Ohio, 44320

  • Neurology of Central Florida Rsch Ctr Site #803

    Altamonte Springs, Florida, 32714

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Advanced Research Center, Inc. Site #835

    Anaheim, California, 92805

  • NeuroTrials Research Inc

    Atlanta, Georgia, 30342

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Negron Research Services / Humanity Clinical Research Site# 766

    Aventura, Florida, 33180

  • Insight Clinical Trials, LLC Site #570

    Beachwood, Ohio, 44122

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic

    Bennington, Vermont, 05201

  • SFM Clinical Research, LLC Site #563

    Boca Raton, Florida, 33487

  • Bradenton Research Center Site #834

    Bradenton, Florida, 34205

  • Alzheimer Disease Center Site #804

    Braintree, Massachusetts, 02184

  • Clinical Research Of Brandon, LLC Site #838

    Brandon, Florida, 33511

  • Clinical Research of Brandon

    Brandon, Florida, 33511

  • Integrative Clinical Trials LLC #1

    Brooklyn, New York, 11229

  • Integrative Clinical Trials LLC #2

    Brooklyn, New York, 11229

  • Meridien Research

    Brooksville, Florida, 34601

  • Onyx Clinical Research, LLC

    Caro, Michigan, 48723

  • Valley Medical Research Site #788

    Centerville, Ohio, 45459

  • Valley Medical Research

    Centerville, Ohio, 45459

  • MD First Research, LLC Site #767

    Chandler, Arizona, 85286

  • Herbert Harris, Md, Phd, Pa

    Chapel Hill, North Carolina, 27517

  • RH Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Roper St. Francis Healthcare

    Charleston, South Carolina, 29401

  • ANI Neurology PLLC dba Alzheimer's Memory Center

    Charlotte, North Carolina, 28270

  • Galen Research

    Chesterfield, Missouri, 63005

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Ericksen Research and Development

    Clinton, Utah, 84015

  • Columbus Research & Wellness Institute, INC

    Columbus, Georgia, 31904

  • Medical Research & Health Education Foundation, Inc.

    Columbus, Georgia, 31909

  • The Ohio State University

    Columbus, Ohio, 43210

  • ATP Clinical Research, Inc. Site #763

    Costa Mesa, California, 92626

  • Millennium Psychiatric Associates, LLC

    Creve Coeur, Missouri, 63141

  • Texas Neurology, P.A.

    Dallas, Texas, 75214

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75231

  • University Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • NeuroStudies. Net, LLC

    Decatur, Georgia, 30033

  • Quantum Laboratories, Inc.

    Deerfield Beach, Florida, 33064

  • Lytle and Weiss, PLLC dba Clinical Trials of the Rockies

    Denver, Colorado, 80209

  • InSite Clinical Research Site #576

    DeSoto, Texas, 75115

  • Moonshine Research Center, Inc

    Doral, Florida, 33166

  • Science Connections, LLC Site #814

    Doral, Florida, 33178

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Michigan State University Department of Neurology

    East Lansing, Michigan, 48824

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • The Samuel & Alexia Bratton Memory Clinic

    Easton, Maryland, 21601

  • Core Clinical Research Site #772

    Everett, Washington, 98201

  • Health Initiatives Research

    Fayetteville, Arkansas, 72703

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • Finlay Medical Research Corp

    Greenacres City, Florida, 33467

  • Mir Neurology

    Hagerstown, Maryland, 21742

  • Direct Helpers Research Center #801

    Hialeah, Florida, 33012

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • New Life Medical Research Center, Inc.

    Hialeah, Florida, 33012

  • Reliable Clinical Research,LLC

    Hialeah, Florida, 33012

  • Research in Miami, Inc

    Hialeah, Florida, 33013

  • The Research Center, Inc

    Hialeah, Florida, 33013

  • Berma Research Group

    Hialeah, Florida, 33016

  • Galiz Research

    Hialeah, Florida, 33016

  • Maxblue Institute

    Hialeah, Florida, 33018

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, Indiana, 46256

  • Irvine Center for Clinical Research

    Irvine, California, 92614

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Alphab Global Research #793

    Jupiter, Florida, 33458

  • SIH Research, LLC

    Kissimmee, Florida, 34741

  • Alzheimer's Research and Treatment Center #1

    Lake Worth, Florida, 33449

  • Alzheimer's Research and Treatment Center #2

    Lake Worth, Florida, 33449

  • Alzheimer's Research and Treatment Center #3

    Lake Worth, Florida, 33449

  • Meridien Research Site #558

    Lakeland, Florida, 33803

  • Sheenath Clinical Service Site #770

    Lakewood, California, 90805

  • Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital

    Lakewood, Ohio, 44107

  • Innovative Clinical Research, Inc. Site #819

    Lauderhill, Florida, 33319

  • MidAmerica Neuroscience Research Foundation

    Lenexa, Kansas, 66214

  • Torrance Clinical Research Institute, Inc. Site #826

    Lomita, California, 90717

  • Collaborative Neuroscience Network, LLC.

    Long Beach, California, 90806

  • Alliance for Wellness, Inc dba Alliance for Research Site #789

    Long Beach, California, 90807

  • PRX Research Site #825

    Mesquite, Texas, 75149

  • Homestead Associates in Research Site# 797

    Miami, Florida, 33032

  • Premier Clinical Research Institute, Inc. #1

    Miami, Florida, 33122

  • Premier Clinical Research Institute, Inc. #2

    Miami, Florida, 33122

  • Central Miami Medical Institute Site #798

    Miami, Florida, 33125

  • Global Medical Institutes, LLC

    Miami, Florida, 33125

  • Optimus U Corp

    Miami, Florida, 33125

  • Project 4 Research #1

    Miami, Florida, 33125

  • Project 4 Research #2

    Miami, Florida, 33125

  • BioMed Research Institute

    Miami, Florida, 33126

  • Finlay Medical Research Corp Site #552

    Miami, Florida, 33126

  • First Class Medical Services Site #807

    Miami, Florida, 33126

  • CCM Clinical Research Group

    Miami, Florida, 33133

  • Innova Clinical Trials

    Miami, Florida, 33133

  • Advance Medical Research Center #1

    Miami, Florida, 33135

  • Advance Medical Research Center #2

    Miami, Florida, 33135

  • Dade Research Center Llc

    Miami, Florida, 33135

  • Vitae Researrch Center LLC

    Miami, Florida, 33135

  • University of Miami

    Miami, Florida, 33136

  • Miami Jewish Health Systems, Inc.

    Miami, Florida, 33137

  • United Health Research Corp. #1

    Miami, Florida, 33144

  • United Health Research Corp. #2

    Miami, Florida, 33144

  • Advanced Medical Center Group

    Miami, Florida, 33145

  • Future Care Solution, LLC

    Miami, Florida, 33165

  • Reliant Medical Research LLC Site #811

    Miami, Florida, 33165

  • Hope Research Network LLC Site #773

    Miami, Florida, 33166

  • Clinical Research Associates of South Florida #1

    Miami, Florida, 33172

  • Clinical Research Associates of South Florida #2

    Miami, Florida, 33172

  • Coral Research Clinic Corp

    Miami, Florida, 33175

  • P&S RESEARCH, LLC. Site #805

    Miami, Florida, 33175

  • Pharmax Research of South Florida

    Miami, Florida, 33175

  • Kendall Research Institute

    Miami, Florida, 33183

  • Nuovida Research Center Corp.

    Miami, Florida, 33186

  • New Med Research, Inc Site #812

    Miami Gardens, Florida, 33056

  • NorthStar Medical Research Site #778

    Middleburg Heights, Ohio, 44130

  • The NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Collier Neurologic Specialists, LLC

    Naples, Florida, 34102

  • Naples Research, Inc

    Naples, Florida, 34102

  • Coastal Connecticut Research, LLC

    New London, Connecticut, 06320

  • Bayside Clinical Research Site #556

    New Port Richey, Florida, 34655

  • Columbia University Medical Center

    New York, New York, 10032

  • Manhattan Behavioral Medicine, PLLC

    New York, New York, 10036

  • Eastside Comprehensive Medical Center, LLC

    New York, New York, 10128

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Research Centers of America, LLC

    Oakland Park, Florida, 33334

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Oklahoma Clinical Research Center

    Oklahoma City, Oklahoma, 73112

  • NRC Research Institute

    Orange, California, 92868

  • Nathan S. Kline Institute for Psychiatric Research #1

    Orangeburg, New York, 10962

  • Nathan S. Kline Institute for Psychiatric Research #571

    Orangeburg, New York, 10962

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Combined Research Orlando Site #799

    Orlando, Florida, 32807

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Four Rivers Clinical Research Inc.

    Paducah, Kentucky, 42003

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 03157

  • IMIC Inc.

    Palmetto Bay, Florida, 33157

  • Innovation Medical Research Center Site #802

    Palmetto Bay, Florida, 33157

  • California Neurological Services

    Panorama City, California, 91402

  • Havana Research Institute Site 787

    Pasadena, California, 91105

  • Havana Research Institute

    Pasadena, California, 91105

  • University of West Florida

    Pensacola, Florida, 32514

  • NoesisPharma, LLC

    Phoenix, Arizona, 85032

  • Neurostudies Inc. Site#796

    Port Charlotte, Florida, 33952

  • Alzheimer's Disease Center

    Quincy, Massachusetts, 02169

  • University of Rochester Medical Center

    Rochester, New York, 14620

  • Veteran Affairs Medical Center, Salem Virginia

    Salem, Virginia, 24153

  • Pharmaceuticals Research Associates, Inc.

    Salt Lake City, Utah, 84107

  • Texas Medical Research Associates, L.L.C.

    San Antonio, Texas, 78238

  • Pacific Research Network, Inc. #1

    San Diego, California, 92103

  • Pacific Research Network, Inc. #2

    San Diego, California, 92103

  • HB Clinical Trials Inc.

    Santa Ana, California, 92704

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Roskamp Institute

    Sarasota, Florida, 34243

  • Perseverance Research Center, LLC

    Scottsdale, Arizona, 85254

  • BG Neurology

    Spartanburg, South Carolina, 29307

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Olympian Clinical Research

    Tampa, Florida, 33609

  • VICIS Clinical Research Inc. Site #777

    Tampa, Florida, 33615

  • Viking Clinical Research

    Temecula, California, 92591

  • Compass Research North, LLC

    The Villages, Florida, 32162

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Oakland Medical Research Site #762

    Troy, Michigan, 48085

  • IPC Research

    Waukesha, Wisconsin, 53188

  • Neurology Research Institute Palm Beach, LLC #1

    West Palm Beach, Florida, 33407

  • Neurology Research Institute Palm Beach, LLC #2

    West Palm Beach, Florida, 33407

  • Burke Rehabilitation Hospital

    White Plains, New York, 10605

  • Abington Neurological Associates, LTD

    Willow Grove, Pennsylvania, 19090

  • Florida Premier Research Institute

    Winter Park, Florida, 32789

  • Neuropsychiatric Associates

    Woodstock, Vermont, 05091

Other trials in United States

Poland12 sites

  • Ksiedza Hugona Kollataja 9

    Bydgoszcz

  • Care Clinic Clinical Research Site #750

    Katowice

  • Wielospecjalistyczna Poradnia Lekarska Synapsis Site #741

    Katowice

  • Krakowska Akademia Neurologii Site #740

    Krakow

  • Malopolskie Centrum Medyczne Site #747

    Krakow

  • Medycyna Milorzab Site #743

    Lodz

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol Site #757

    Nowa Sól, Lubusz Voivodeship, 67-100

  • Solumed Centrum Medyczne Site #753

    Poznan

  • RCMed Oddział Sochaczew Site #510

    Sochaczew, Masovian Voivodeship, 96-500

  • Centrum Medyczne Euromedis

    Szczecin

  • Centrum Medyczne NeuroProtect Site #742

    Warsaw

  • ClinHouse Centrum Medyczne

    Zabrze, 41-807

Other trials in Poland

Czechia11 sites

  • Fakultni Nemocnice u sv. Anny v Brne Site #722

    Brno

  • Fakultní Nemocnice Hradec Králové Site #724

    Hradec Kralové

  • NeuropsychiatrieHK Site #729

    Hradec Kralové

  • Brain-Soultherapy

    Kladno

  • Námestí národního odboje 692 Site #723

    Kutná Hora

  • A-Shine s.r.o. Site #731

    Pilsen

  • AD71

    Prague

  • Clintrial

    Prague

  • Neurologicka Ambulance - Forbeli

    Prague

  • Neuropsychiatrie Site #726

    Prague

  • Vestra Clinics

    Rychnov nad Kněžnou

Other trials in Czechia

Spain8 sites

  • Accellacare Alcobendas

    Alcobendas, 28100

  • Fundació ACE

    Barcelona

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital General Universitario de Elche

    Elche

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital Universitario Virgen Macarena Site #649

    Seville

  • Complejo Asistencial de Zamora Hospital Virgen de la Concha

    Zamora

  • Hospital Viamed Montecanal Site #643

    Zaragoza

Other trials in Spain

Bulgaria7 sites

  • Center for Mental Health - Ruse

    Rousse

  • Mental Health Centre Prof. Nikola Shipkovenski Site #713

    Sofia, 1000

  • Medical Center Sveti Naum Site #707

    Sofia, 1113

  • Vrach and Sv. Sv. Kuzma and Damian Site #710

    Sofia, 1408

  • University Multiprofile Hospital for Active Treatment Alexandrovska Site #704

    Sofia

  • Medical Center Mladost-M

    Varna, 9020

  • Medica Plus Medical Center

    Veliko Tarnovo

Other trials in Bulgaria

Hungary6 sites

  • Dr. Kenessey Albert Kórház-Rendelőintézet

    Balassagyarmat

  • Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly Site #586

    Budapest

  • Semmelweis Egyetem

    Budapest

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

    Debrecen

  • Dr. Mathe es Tarsa Beteti Tarsasag Site #593

    Kalocsa, 6300

  • PsychoTech Clinical Research Site# 580

    Pécs

Other trials in Hungary

South Africa5 sites

  • ACF Neurological Services

    Cape Town

  • Cape Trial Centre

    Cape Town

  • Flexivest Fourteen Research Centre

    Cape Town

  • Apollo Clinical Research Site #623

    Johannesburg

  • Medical and Dental Centre

    Rosebank

Other trials in South Africa

France3 sites

  • Centre Hospitalier Universitaire Dijon Bourgogn Site #536

    Dijon

  • Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord Site #535

    Saint-Etienne, Auvergne-Rhône-Alpes

  • Centre Hospitalier Universitaire Toulouse - Casselardit Ancely Site #533

    Toulouse

Other trials in France

Italy3 sites

  • Azienda Ospedaliera Sant'Andrea Site #606

    Roma

  • Fondazione Policlinico Tor Vergata Site #609

    Roma

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

    Roma

Other trials in Italy

Canada1 site

  • Dr. Alexander McIntyre Inc.

    Penticton

Other trials in Canada

About this study

Official title: 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 was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.

Read the detailed description

Eligible participants for this study had successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.

Study medication was administered orally twice daily.

Being tested
AVP-786

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVP-786Drug

Study groups in NCT02446132
Study groupRoleWhat they receive
AVP-786 18 milligrams (mg)ExperimentalParticipants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
Receives: Drug: AVP-786
AVP-786 28 mgExperimentalParticipants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
Receives: Drug: AVP-786
AVP-786 42.63 mgExperimentalParticipants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
Receives: Drug: AVP-786

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE)is any untoward medical occurrence or unintended change (e.g. physical, psychological, or behavioral), including inter-current illness, whether considered related to treatment or not. An AE can therefore be any unfavorable and unintended sign (including any clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is defined as an AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.

    Measured: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)

  2. Number of Participants With Serious TEAE

    A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongation of hospitalization or congenital anomaly/birth defect. A serious TEAE is defined as AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.

    Measured: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)

  3. Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities

    Laboratory assessments included clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, cholesterol, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, protein, potassium, sodium, triglycerides and uric acid), hematology (basophils, eosinophils/leukocytes, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils/leukocytes, platelets). Number of participants with clinically significant laboratory test abnormalities were reported as per criteria defined in statistical analysis plan (SAP). The categories with at least one participant with potentially clinically significant laboratory values are reported.

    Measured: Baseline (current study) up to 52 weeks

  4. Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities

    A resting 12-lead ECG was performed for all the participants. ECG data included PR interval (milliseconds {msec}) and QTcF (msec) along with change from baseline in QTcF. Number of participants with potentially clinically significant ECG abnormalities was reported as per the criteria defined in SAP.

    Measured: Baseline (current study) up to 52 weeks

  5. Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding

    The physical examination included assessments of head, eyes, ears, nose, throat, lymph nodes, skin, extremities, respiratory, gastrointestinal, musculoskeletal, cardiovascular, and nervous systems. The neurological examination included assessments of mental status, cranial nerves, motor system, reflexes, coordination, gait and station, and sensory system.

    Measured: Baseline (current study), Week 52

  6. Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs

    Vital signs measurements included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR). Blood pressure (i.e., SBP, DBP) and heart rate were measured in the supine and standing positions after the participant had been in each position for at least 5 and 3 minutes, respectively. Number of participants with clinically significant vital sign abnormalities were reported as per criteria defined in SAP. The categories with at least one participant with clinically significant vital signs abnormalities are reported here.

    Measured: Baseline (current study) up to 52 weeks

  7. Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64

    The S-STS is a prospective scale that assesses treatment-emergent suicidal thoughts and behaviors. This is a 20-item scale where each item (except item 17) of the S-STS is scored on a 5-point Likert scale as: 0 = Not at all, 1 = A little, 2 = Moderate, 3 = Very, 4 = Extremely. The S-STS total score is calculated by the sum of items 1a (if present), items 2-11, highest score of item 12 or 16, highest score of item 14 or 15, item 17 and 20. The total score ranges from 0 to 156 (If response to S-STS item 17 =yes, a score of 100 was added to the S-STS total score). Higher scores indicate greater severity of suicidal ideation and/or behavior. A negative change from baseline reflects a reduction in suicidal thoughts or behaviors over time.

    Measured: Baseline (current study), Week 64

  8. Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 52

    The MMSE is a brief questionnaire that is used to assess cognitive impairment and severity of cognitive impairment. The MMSE scale comprises 11 questions or simple tasks concerning orientation, memory, attention, and language to evaluate a participant's cognitive state and are scored as follows: Orientation to Time - 0 to 5; Orientation to Place - 0 to 5; Registration - 0 to 3; Attention and Calculation - 0 to 5; Recall - 0 to 3; Naming - 0 to 2; Repetition - 0 to 1; Comprehension - 0 to 3; Reading - 0 to 1; Writing - 0 to 1; Drawing - 0 to 1. The total score was calculated by summing all of the item scores and ranges from 0 to 30. Higher scores indicate milder cognitive impairment. Negative change from baseline indicates decline in cognitive performance.

    Measured: Baseline (current study), Week 52

  9. Change From Baseline in the Epworth Sleepiness Scale (ESS) Score at Week 52

    The ESS is an 8-item questionnaire that is used to measure sleepiness by rating the probability of falling asleep on 8 different situations that most people engage in during the day. The 8 questions are rated on a 4-point scale (0 to 3) where 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 3 = high chance of dozing. The scores are summed to give an overall score of 0 to 24. A total score of 0 to 9 is considered to be normal. Higher score indicates greater daytime sleepiness. Negative change from baseline indicate improvement in daytime sleepiness.

    Measured: Baseline (current study), Week 52

Secondary outcomes (8)

  1. Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score at Week 64

    The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = once or twice a week, 4 = several times a week, 5 = once or twice a day, 6 = several times a day, 7 = several times an hour). The ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviours while lower scores indicate lower frequency of agitated behaviours.

    Measured: Baseline (current study), Week 64

  2. Change From Baseline in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI) at Week 52

    The NPI is a validated clinical instrument used to assess neuropsychiatric symptoms. It evaluates 12 neuropsychiatric symptom domains including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavioral disorders, and appetite/eating disorders. Each symptom domain is rated by the caregiver based on the frequency (1 to 4) and severity (1 to 3) of symptoms, and a composite domain score is calculated by multiplying frequency and severity (range: 1-12). Additionally, caregiver distress for each positive symptom domain is rated on a 6-point scale (0 = not at all distressing, 5 = extremely distressing). In this study, the three NPI domains assessed were agitation/aggression, irritability/lability, and aberrant motor behavior. Higher scores indicate greater severity and frequency of neuropsychiatric symptoms.

    Measured: Baseline (current study), Week 52

  3. Change From Baseline in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score at Week 64

    The mADCS-CGIC-Agitation is used to assess agitation in individuals with Alzheimer's disease. It includes questions focused on agitation and uses a semi-structured interview format involving both the participant and their caregiver. The clinician rates the participant's overall clinical status using a 7-point scale: 1 = marked improvement, 2 = moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, and 7 = marked worsening. Lower scores indicate improvement in agitation symptoms, while higher scores indicate worsening.

    Measured: Baseline (current study), Week 64

  4. Change From Baseline in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score at Week 52

    The CGIS is an observer-rated scale that measures illness severity. The CGIS-Agitation is a 7-point (1-7) scale (1 = normal, not at all ill; 7 = extremely ill) that assessed the severity of agitation in this study. Higher scores indicate severe agitation, while the lower scores indicate little or no agitation.

    Measured: Baseline (current study), Week 52

  5. Change From Baseline in the Patient Global Impression of Change (PGIC) Score at Week 52

    The PGIC is a 7-point scale used to assess perceived treatment response, as evaluated by the participant's caregiver. The caregiver rates the overall change in the participant's condition since the start of treatment. The PGIC score ranges from 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Lower scores reflect greater improvement, while higher scores indicate worsening of the participant's condition.

    Measured: Baseline (current study), Week 52

  6. Change From Baseline in the Dementia Quality of Life (DEMQOL) Score at Week 52

    The DEMQOL is a validated scale used to assess health-related quality of life in individuals with dementia and their caregivers. It includes two versions: a 28-item version completed by the participant (DEMQOL), and a 31-item proxy version completed by the caregiver (DEMQOL-proxy). Each item is rated using a 4-point scale to reflect the frequency or severity of health-related concerns: 1 = A lot, 2 = Quite a bit, 3 = A little, 4 = Not at all. Total score is derived by sum of all item scores, excluding item 29 of DEMQOL and item 32 of DEMQOL-proxy. Lower scores indicate better quality of life.

    Measured: Baseline (current study), Week 52

  7. Change From Baseline in the Resource Utilization in Dementia (RUD) Score at Week 52

    The RUD is a standardized tool used to estimate healthcare costs associated with dementia. It assesses the use of both formal and informal (e.g., hospitalizations, doctor visits, living assistance, and unprofessional caregiver time) healthcare resources. The instrument is administered as a semi-structured interview with the participant's primary caregiver. It consists of two main sections: one evaluates the caregiver's burden, including lost work and leisure time, and the other documents the participant's use of healthcare services. Total healthcare costs are calculated by multiplying the quantity of resources used (e.g., number of doctor visits, hours of caregiver, nights in accommodation) by unit costs. Higher estimated totals reflect greater economic impact associated with dementia care.

    Measured: Baseline (current study), Week 52

  8. Change From Baseline in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants From Study 17-AVP-786-305 at Week 52

    The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life. It consists of two components: a descriptive system and the EuroQol Visual Analogue Scale (EQ VAS). The descriptive system covers five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale: 1 = No problems, 2 = Slight problems, 3 = Moderate problems, 4 = Severe problems, 5 = Extreme problems. The EQ VAS component allows participants or caregivers to rate the individual's overall health on a vertical scale from 0 (the worst imaginable health state) to 100 (the best imaginable health state). Only participants from Study 17-AVP-786-305 with a MMSE score of 10 or higher at the baseline visit were planned to complete the participant-rated version.

    Measured: Baseline (current study), Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2015 (estimated)
  2. Study start13 Nov 2015
  3. Primary completion6 Sep 2024
  4. Study completion6 Sep 2024

Why it stopped: The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02446132
Sponsor's protocol ID
15-AVP-786-303
Other IDs
2017-002455-29, 2017
Status last verified
Aug 2025
First submitted
11 May 2015
Last updated
15 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AVP-786 in people with Agitation in Patients With Dementia of the Alzheimer's Type, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 227 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in United States, Poland, Czechia, Spain, Bulgaria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.

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