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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02442778
Recruitment Status : Active, not recruiting
First Posted : May 13, 2015
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE May 11, 2015
First Posted Date  ICMJE May 13, 2015
Last Update Posted Date July 17, 2019
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
NPI Agitation/Aggression Domain [ Time Frame: 12 weeks ]
Neuropsychiatric Inventory (NPI)
Change History Complete list of historical versions of study NCT02442778 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
  • 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) ]
  • Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the NPI Caregiver Distress Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the Zarit Burden Interview (ZBI) Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the NPI Total Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score [ Time Frame: Baseline; Week 12 ]
  • 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 ]
  • Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Score [ Time Frame: Baseline; Week 12 ]
    PGIC (rated by caregiver)
  • Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline in the Cornell Scale for Depression in Dementia (CSDD) Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the General Medical Health Rating (GMHR) Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline in the Resource Utilization in Dementia (RUD) Score [ Time Frame: Baseline; Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • ADCS-CGIC Agitation [ Time Frame: 12 weeks ]
    Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change Agitation
  • NPI- Individual Domain and Total NPI Score [ Time Frame: 12 weeks ]
    Neuropsychiatric Inventory (NPI)
  • NPI- Agitation/Aggression Caregiver Distress [ Time Frame: 12 weeks ]
    Neuropsychiatric Inventory (NPI)
  • PGIC [ Time Frame: 12 weeks ]
    Patient Global Impression of Change (rated by caregiver)
  • DEMQOL [ Time Frame: 12 weeks ]
    Dementia Quality of Life
  • Zarit Burden Scale [ Time Frame: 12 weeks ]
    Zarit Burden Scale
  • RUD [ Time Frame: 12 weeks ]
    Resource Utilization in Dementia
  • EQ-5D-5L [ Time Frame: 12 weeks ]
    EuroQol 5-Demension 5-Level
  • ADAS-Cog [ Time Frame: 12 weeks ]
    Alzheimer's Disease Assessment Scale- Cognitive Subscale
  • MMSE [ Time Frame: 12 weeks ]
    Mini Mental State Examination
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Official Title  ICMJE 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.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Agitation in Patients With Dementia of the Alzheimer's Type
Intervention  ICMJE
  • Drug: AVP-786
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo capsules administered twice a day over a 12-week period
    Intervention: Drug: Placebo
  • Experimental: AVP-786 (dose 1)
    AVP-786 dose 1; capsules administered twice a day over a 12-week period
    Intervention: Drug: AVP-786
  • Experimental: AVP-786 (dose 2)
    AVP-786 dose 2; capsules administered twice a day over a 12-week period
    Intervention: Drug: AVP-786
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 21, 2019)
522
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
325
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02442778
Other Study ID Numbers  ICMJE 15-AVP-786-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avanir Pharmaceuticals
Study Sponsor  ICMJE Avanir Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avanir Pharmaceuticals
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP