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Efficacy, Safety, and Tolerab...

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

Last Updated: 2022-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-11

Study Completion Date

2019-09-09

Brief Summary

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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.

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Detailed Description

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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 Week 12 (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.

Conditions

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Agitation in Participants With Dementia of the Alzheimer's Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Participants were administered AVP-786 matching placebo capsules, orally, twice daily (BID) for up to 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered as capsules.

AVP-786-28

Participants were administered AVP-786-18 capsule, orally, once daily (QD) along with AVP-786 matching placebo capsule, orally, QD during Week 1 followed by AVP-786-18 capsules, orally, BID during Weeks 2, 3 and AVP-786-28 capsules, orally, BID during Weeks 4 to 12.

Group Type EXPERIMENTAL

AVP-786-18

Intervention Type DRUG

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

AVP-786-28

Intervention Type DRUG

28 mg of d6-DM and 4.9 mg of Q

AVP-786-42.63

Participants were administered AVP-786-28 capsules, orally, QD along with AVP-786 matching placebo capsule, orally, QD during Week 1 followed by AVP-786-28 capsules, orally, BID during Weeks 2, 3, and AVP-786-42.63 capsules, orally, BID during Weeks 4 to 12.

Group Type EXPERIMENTAL

AVP-786-28

Intervention Type DRUG

28 mg of d6-DM and 4.9 mg of Q

AVP-786-42.63

Intervention Type DRUG

42.63 mg of d6-DM and 4.9 mg of Q

Interventions

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AVP-786-18

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

Intervention Type DRUG

Placebo

Administered as capsules.

Intervention Type DRUG

AVP-786-28

28 mg of d6-DM and 4.9 mg of Q

Intervention Type DRUG

AVP-786-42.63

42.63 mg of d6-DM and 4.9 mg of Q

Intervention Type DRUG

Eligibility Criteria

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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 participants 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

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brain and Spine Center

Chandler, Arizona, United States

Site Status

Territory Neurology & Research Institute

Tucson, Arizona, United States

Site Status

Health Initiatives Research

Fayetteville, Arkansas, United States

Site Status

Behavioral Research Specialists, LLC

Glendale, California, United States

Site Status

Irvine Center for Clinical Research

Irvine, California, United States

Site Status

California Neurological Services

Panorama City, California, United States

Site Status

Havana Research Institute

Pasadena, California, United States

Site Status

Pacific Research Network, Inc

San Diego, California, United States

Site Status

Syrentis Clinical Research

Santa Ana, California, United States

Site Status

Viking Clinical Research

Temecula, California, United States

Site Status

Denver Neurological Research, LLC

Denver, Colorado, United States

Site Status

JEM Research Institute

Atlantis, Florida, United States

Site Status

Clinical Research Of Brandon, LLC

Brandon, Florida, United States

Site Status

Meridien Research

Brooksville, Florida, United States

Site Status

Moonshine Research Center, Inc

Doral, Florida, United States

Site Status

Science Connections, LLC

Doral, Florida, United States

Site Status