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Long Term, Extension Study of...

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

Last Updated: 2025-10-15

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-13

Study Completion Date

2024-09-06

Brief Summary

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This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.

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Detailed Description

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Eligible participants for this study had successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.

Study medication was administered orally twice daily.

Conditions

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Agitation in Patients With Dementia of the Alzheimer's Type

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AVP-786 18 milligrams (mg)

Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

AVP-786 28 mg

Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

AVP-786 42.63 mg

Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Interventions

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AVP-786

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
* Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
* Either out-patients or residents of an assisted-living facility or a skilled nursing home
* Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
* Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
* Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
* Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline

Exclusion Criteria

* 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)
* Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
* Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline

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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MD First Research, LLC Site #767

Chandler, Arizona, United States

Site Status

NoesisPharma, LLC

Phoenix, Arizona, United States

Site Status

Perseverance Research Center, LLC

Scottsdale, Arizona, United States

Site Status

Health Initiatives Research

Fayetteville, Arkansas, United States

Site Status

Advanced Research Center, Inc. Site #835

Anaheim, California, United States

Site Status

ATP Clinical Research, Inc. Site #763

Costa Mesa, California, 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

Sheenath Clinical Service Site #770

Lakewood, California, United States

Site Status

Torrance Clinical Research Institute, Inc. Site #826

Lomita, California, United States

Site Status

Collaborative Neuroscience Network, LLC.

Long Beach, California, United States

Site Status

Alliance for Wellness, Inc dba Alliance for Research Site #789

Long Beach, California, United States

Site Status

NRC Research Institute

Orange, California, United States

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California Neurological Services

Panorama City, California, United States

Site Status

Havana Research Institute Site 787

Pasadena, California, United States

Site Status

Havana Research Institute

Pasadena, California, United States

Site Status

Pacific Research Network, Inc. #1

San Diego, California, United States

Site Status

Pacific Research Network, Inc. #2

San Diego, California, United States

Site Status

HB Clinical Trials Inc.

Santa Ana, California, United States

Site Status

Syrentis Clinical Research

Santa Ana, California, United States

Site Status

Viking Clinical Research

Temecula, California, United States

Site Status

Lytle and Weiss, PLLC dba Clinical Trials of the Rockies

Denver, Colorado, United States

Site Status

Coastal Connecticut Research, LLC

New London, Connecticut, United States

Site Status

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, United States

Site Status

Neurology of Central Florida Rsch Ctr Site #803

Altamonte Springs, Florida, United States

Site Status

JEM Research Institute

Atlantis, Florida, United States

Site Status

Negron Research Services / Humanity Clinical Research Site# 766

Aventura, Florida, United States

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SFM Clinical Research, LLC Site #563

Boca Raton, Florida, United States

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Bradenton Research Center Site #834

Bradenton, Florida, United States

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Clinical Research Of Brandon, LLC Site #838

Brandon, Florida, United States

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Clinical Research of Brandon

Brandon, Florida, United States

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Meridien Research

Brooksville, Florida, United States

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Quantum Laboratories, Inc.

Deerfield Beach, Florida, United States

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Moonshine Research Center, Inc

Doral, Florida, United States

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Science Connections, LLC Site #814

Doral, Florida, United States

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