Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type

PHASE3CompletedINTERVENTIONAL
Enrollment

522

Participants

Timeline

Start Date

November 11, 2015

Primary Completion Date

August 14, 2019

Study Completion Date

September 9, 2019

Conditions
Agitation in Participants With Dementia of the Alzheimer's Type
Interventions
DRUG

AVP-786-18

18 mg of Deudextromethorphan hydrobromide (d6-DM) and 4.9 mg of Quinidine sulfate (Q)

DRUG

Placebo

Administered as capsules.

DRUG

AVP-786-28

28 mg of d6-DM and 4.9 mg of Q

DRUG

AVP-786-42.63

42.63 mg of d6-DM and 4.9 mg of Q

Trial Locations (83)

10128

Eastside Comprehensive Medical Center, LLC, New York

10605

Burke Rehabilitation Hospital, White Plains

11214

Brooklyn Medical Institute, Brooklyn

11229

Integrative Clinical Trials, LLC, Brooklyn

15009

Heritage Valley Medical Group, Inc., Beaver

19056

The Birches at Newton / Family Medical Associates, Levittown

19107

Thomas Jefferson University, Philadelphia

21601

The Samuel & Alexia Bratton Memory Clinic, Easton

21742

Mir Neurology, Hagerstown

24153

Veteran Affairs Medical Center, Salem Virginia, Salem

27517

Herbert Harris, MD, PhD, PA, Chapel Hill

28270

ANI Neurology PLLC dba Alzheimer's Memory Center, Charlotte

29307

BG Neurology, Spartanburg

29401

RH Johnson VA Medical Center, Charleston

30329

Emory Brain Health Center, Atlanta

31904

Columbus Research & Wellness Institute, INC, Columbus

32256

Clinical Neuroscience Solutions, Inc., Jacksonville

32514

University of West Florida, Pensacola

32806

Compass Research, LLC, Orlando

33012

Indago Research & Health Center, Inc., Hialeah

New Life Medical Research Center, Inc., Hialeah

Reliable Clinical Research,LLC, Hialeah

33013

Research in Miami, Inc, Hialeah

The Research Center, Inc, Hialeah

33018

Maxblue Institute, Hialeah

33122

Premier Clinical Research Institute, Inc., Miami

33125

Project 4 Research, Miami

33126

BioMed Research Institute, Miami

33133

CCM Clinical Research Group, Miami

33135

DADE Research Center, LLC, Miami

33144

AMB Research Center, Inc., Miami

United Health Research Corp, Miami

33157

IMIC Inc., Palmetto Bay

33165

Advance Medical Research Center, Miami

33166

Moonshine Research Center, Inc, Doral

Science Connections, LLC, Doral

33175

Coral Research Clinic Corp, Miami

P&S Reasearch, Miami

33176

The Neurology Research Group, LLC, Miami

33183

Kendall Research Institute, Miami

33186

Nuovida Research Center Corp., Miami

33407

Neurology Research Institute Palm Beach, LLC, West Palm Beach

33408

Lazlo J. Mate, MD, PA, North Palm Beach

33449

Alzheimer's Research and Treatment Center, Lake Worth

33462

JEM Research Institute, Atlantis

33467

Finlay Medical Research Corp, Greenacres City

33511

Clinical Research Of Brandon, LLC, Brandon

34102

Collier Neurologic Specialists, LLC, Naples

34601

Meridien Research, Brooksville

40475

Baptist Health Medical Group, Richmond

44107

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

44313

Daystar Clinical Research Inc, Akron

45212

CTI Clinical Research Center, Cincinnati

45459

Valley Medical Research, Centerville

46256

Josephson Wallack Munshower Neurology, PC, Indianapolis

48824

Michigan State University, East Lansing

53188

IPC Research, Waukesha

72703

Health Initiatives Research, Fayetteville

75214

Texas Neurology, P.A., Dallas

77030

Baylor College of Medicine, Houston

Houston Methodist Neurological Institute, Houston

77074

Clinical Trial Network, Houston

78238

Texas Medical Research Associates, L.L.C., San Antonio

80210

Denver Neurological Research, LLC, Denver

84107

Pharmaceuticals Research Associates, Inc., Salt Lake City

85226

Brain and Spine Center, Chandler

85704

Territory Neurology & Research Institute, Tucson

91105

Havana Research Institute, Pasadena

91206

Behavioral Research Specialists, LLC, Glendale

91402

California Neurological Services, Panorama City

92103

Pacific Research Network, Inc, San Diego

92591

Viking Clinical Research, Temecula

92614

Irvine Center for Clinical Research, Irvine

92705

Syrentis Clinical Research, Santa Ana

02459

Boston Center for Memory, Newton

02747

AMAC Research Institute, North Dartmouth

08002

Center for Emotional Fitness, Cherry Hill

07856

The NeuroCognitive Institute, Mount Arlington

05201

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

N7L 1C1

Dr. Alexander McIntyre Inc., Calgary

Unknown

The Medical Art Health Research Group, Kelowna

The Medical Art Health Research Group, Penticton

The Medical Art Health Research Group, West Vancouver

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT02442778 - Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type | Biotech Hunter | Biotech Hunter