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

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ClinicalTrials.gov Identifier: NCT02442778
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

Condition or disease Intervention/treatment Phase
Agitation in Patients With Dementia of the Alzheimer's Type Drug: AVP-786 Drug: Placebo Phase 3

Detailed Description:

Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD.

This is a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment.

Approximately 470 participants will be enrolled at approximately 75 centers in North America.

Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 522 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability 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.
Study Start Date : September 2015
Actual Primary Completion Date : August 14, 2019
Actual Study Completion Date : September 9, 2019


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsules administered twice a day over a 12-week period
Drug: Placebo
Experimental: AVP-786 (dose 1)
AVP-786 dose 1; capsules administered twice a day over a 12-week period
Drug: AVP-786
Experimental: AVP-786 (dose 2)
AVP-786 dose 2; capsules administered twice a day over a 12-week period
Drug: AVP-786



Primary Outcome Measures :
  1. Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 12; Follow-up Visit (30 days post last dose of study medication for participants who terminate early) ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation (Global Clinical Status of Agitation on mADCS-CGIC Scale) Score [ Time Frame: Baseline; Week 12; Follow-up Visit (30 days post last dose of study medication for participants who terminate early) ]
  2. Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score [ Time Frame: Baseline; Week 12 ]
  3. Change from Baseline to Week 12 in the NPI Caregiver Distress Score [ Time Frame: Baseline; Week 12 ]
  4. Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score [ Time Frame: Baseline; Week 12 ]
  5. Change from Baseline to Week 12 in the Zarit Burden Interview (ZBI) Score [ Time Frame: Baseline; Week 12 ]
  6. Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score [ Time Frame: Baseline; Week 12 ]
  7. Change from Baseline to Week 12 in the NPI Total Score [ Time Frame: Baseline; Week 12 ]
  8. Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score [ Time Frame: Baseline; Week 12 ]
  9. Change from Baseline to Week 12 in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Overall Rating [ Time Frame: Baseline; Week 12 ]
  10. Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Score [ Time Frame: Baseline; Week 12 ]
    PGIC (rated by caregiver)

  11. Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Score [ Time Frame: Baseline; Week 12 ]
  12. Change from Baseline in the Cornell Scale for Depression in Dementia (CSDD) Score [ Time Frame: Baseline; Week 12 ]
  13. Change from Baseline to Week 12 in the General Medical Health Rating (GMHR) Score [ Time Frame: Baseline; Week 12 ]
  14. Change from Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score [ Time Frame: Baseline; Week 12 ]
  15. Change from Baseline in the Resource Utilization in Dementia (RUD) Score [ Time Frame: Baseline; Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
  • The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
  • The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
  • Either out patients or residents of an assisted-living facility or a skilled nursing home
  • Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is >=4 (moderately ill) at screening and baseline
  • Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
  • Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

  • Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • 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)
  • Participant with myasthenia gravis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442778


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Locations
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United States, Arizona
Brain and Spine Center
Chandler, Arizona, United States, 85226
Territory Neurology & Research Institute
Tucson, Arizona, United States, 85704
United States, Arkansas
Health Initiatives Research
Fayetteville, Arkansas, United States, 72703
United States, California
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206
Irvine Center for Clinical Research
Irvine, California, United States, 92614
California Neurological Services
Panorama City, California, United States, 91402
Havana Research Institute
Pasadena, California, United States, 91105
Pacific Research Network, Inc
San Diego, California, United States, 92103
Syrentis Clinical Research
Santa Ana, California, United States, 92705
Viking Clinical Research
Temecula, California, United States, 92591
United States, Colorado
Denver Neurological Research, LLC
Denver, Colorado, United States, 80210
United States, Florida
JEM Research Institute
Atlantis, Florida, United States, 33462
Clinical Research Of Brandon, LLC
Brandon, Florida, United States, 33511
Meridien Research
Brooksville, Florida, United States, 34601
Moonshine Research Center, Inc
Doral, Florida, United States, 33166
Science Connections, LLC
Doral, Florida, United States, 33166
Finlay Medical Research Corp
Green Acres, Florida, United States, 33467
Indago Research & Health Center, Inc.
Hialeah, Florida, United States, 33012
New Life Medical Research Center, Inc.
Hialeah, Florida, United States, 33012
Reliable Clinical Research,LLC
Hialeah, Florida, United States, 33012
Research in Miami, Inc
Hialeah, Florida, United States, 33013
The Research Center, Inc
Hialeah, Florida, United States, 33013
Maxblue Institute
Hialeah, Florida, United States, 33018
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States, 33449
Premier Clinical Research Institute, Inc.
Miami, Florida, United States, 33122
Project 4 Research
Miami, Florida, United States, 33125
BioMed Research Institute
Miami, Florida, United States, 33126
CCM Clinical Research Group
Miami, Florida, United States, 33133
DADE Research Center, LLC
Miami, Florida, United States, 33135
AMB Research Center, Inc.
Miami, Florida, United States, 33144
United Health Research Corp
Miami, Florida, United States, 33144
Advance Medical Research Center
Miami, Florida, United States, 33165
Coral Research Clinic Corp
Miami, Florida, United States, 33175
P&S Reasearch
Miami, Florida, United States, 33175
The Neurology Research Group, LLC
Miami, Florida, United States, 33176
Kendall Research Institute
Miami, Florida, United States, 33183
Nuovida Research Center Corp.
Miami, Florida, United States, 33186
Collier Neurologic Specialists, LLC
Naples, Florida, United States, 34102
Lazlo J. Mate, MD, PA
North Palm Beach, Florida, United States, 33408
Compass Research, LLC
Orlando, Florida, United States, 32806
IMIC Inc.
Palmetto Bay, Florida, United States, 33157
University of West Florida
Pensacola, Florida, United States, 32514
Neurology Research Institute Palm Beach, LLC
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory Brain Health Center
Atlanta, Georgia, United States, 30329
Columbus Research & Wellness Institute, INC
Columbus, Georgia, United States, 31904
United States, Indiana
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States, 46256
United States, Kentucky
Baptist Health Medical Group
Richmond, Kentucky, United States, 40475
United States, Maryland
The Samuel & Alexia Bratton Memory Clinic
Easton, Maryland, United States, 21601
Mir Neurology
Hagerstown, Maryland, United States, 21742
United States, Massachusetts
Boston Center for Memory
Newton, Massachusetts, United States, 02459
AMAC Research Institute
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
United States, New Jersey
Center for Emotional Fitness
Cherry Hill, New Jersey, United States, 08002
The NeuroCognitive Institute
Mount Arlington, New Jersey, United States, 07856
United States, New York
Brooklyn Medical Institute
Brooklyn, New York, United States, 11214
Integrative Clinical Trials, LLC
Brooklyn, New York, United States, 11229
Eastside Comprehensive Medical Center, LLC
New York, New York, United States, 10128
Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
United States, North Carolina
Herbert Harris, MD, PhD, PA
Chapel Hill, North Carolina, United States, 27517
ANI Neurology PLLC dba Alzheimer's Memory Center
Charlotte, North Carolina, United States, 28270
United States, Ohio
Daystar Clinical Research Inc
Akron, Ohio, United States, 44313
Valley Medical Research
Centerville, Ohio, United States, 45459
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45212
Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital
Lakewood, Ohio, United States, 44107
United States, Pennsylvania
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States, 15009
The Birches at Newton / Family Medical Associates
Levittown, Pennsylvania, United States, 19056
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
RH Johnson VA Medical Center
Charleston, South Carolina, United States, 29401
BG Neurology
Spartanburg, South Carolina, United States, 29307
United States, Texas
Texas Neurology, P.A.
Dallas, Texas, United States, 75214
Baylor College of Medicine
Houston, Texas, United States, 77030
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
Clinical Trial Network
Houston, Texas, United States, 77074
Texas Medical Research Associates, L.L.C.
San Antonio, Texas, United States, 78238
United States, Utah
Pharmaceuticals Research Associates, Inc.
Salt Lake City, Utah, United States, 84107
United States, Vermont
Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic
Bennington, Vermont, United States, 05201
United States, Virginia
Veteran Affairs Medical Center, Salem Virginia
Salem, Virginia, United States, 24153
United States, Wisconsin
IPC Research
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Dr. Alexander McIntyre Inc.
Calgary, Alberta, Canada, N7L 1C1
Canada, Bristish Columbia
The Medical Art Health Research Group
Kelowna, Bristish Columbia, Canada
The Medical Art Health Research Group
Penticton, Bristish Columbia, Canada
The Medical Art Health Research Group
West Vancouver, Bristish Columbia, Canada
Sponsors and Collaborators
Avanir Pharmaceuticals

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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02442778     History of Changes
Other Study ID Numbers: 15-AVP-786-302
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms