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Purpose

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

Condition

Eligibility

Eligible Ages
Between 50 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria - Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment - Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions - Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation. - Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff - Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the participant

Exclusion Criteria

  • Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia) - Participants with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium) - 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 [except skin basal-cell carcinoma], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease) - Participants with myasthenia gravis

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AVP-786 		Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.
  • Drug: AVP-786
    oral capsules
Placebo Comparator
Placebo 		Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
  • Drug: Placebo
    oral capsules

Recruiting Locations

Clinical Research Site #840-081
Fort Smith, Arkansas 72901

Clinical Research Site
La Jolla, California 92093

Clinical Research Site #840-064
Pasadena, California 91105

Clinical Research Site #840-090
Basalt, Colorado 81621

Clinical Research Site
Atlantis, Florida 33462

Clinical Research Site
Coral Gables, Florida 33134

Clinical Research Site
Doral, Florida 33166

Clinical Research Site
Jacksonville, Florida 32256

Clinical Research Site #840-069
Maitland, Florida 32751

Clinical Research Site #840-083
Maitland, Florida 32751

Clinical Research Site #840-118
Miami, Florida 33032

Clinical Research Site
Miami, Florida 33126

Clinical Research Site
Miami, Florida 33467

Clinical Research Site
Orlando, Florida 32819

Clinical Research Site 840-111
Pembroke Pines, Florida 33024

Clinical Research Site #840-096
Pensacola, Florida 32503

Clinical Research Site #840-112
Tampa, Florida 33615

Clinical Research Site #840-049
Glen Burnie, Maryland 21061

Clinical Research Site #840-093
Rochester Hills, Michigan 48307

Clinical Research Site #840-097
Bronx, New York 10466

Clinical Research Site #840-095
Monroe, North Carolina 28112

Clinical Research Site
Canton, Ohio 44718

Clinical Research Site #840-099
Tulsa, Oklahoma 74136

Clinical Research Site
Bayamon, Puerto Rico 00961

Clinical Research Site #630-005
San Juan, Puerto Rico 926

More Details

NCT ID
NCT04408755
Status
Recruiting
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact

Otsuka Call Center
844-687-8522
OtsukaRMReconciliation@rmpdc.org

Detailed Description

Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD. This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Approximately 750 participants will be enrolled at approximately 110 centers worldwide. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.