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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 | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy 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

NCT02446132•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

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.

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

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

Locations (227)

MD First Research, LLC Site #767

Chandler, Arizona, United States

NoesisPharma, LLC

Phoenix, Arizona, United States

Perseverance Research Center, LLC

Scottsdale, Arizona, United States

Health Initiatives Research

Fayetteville, Arkansas, United States

Advanced Research Center, Inc. Site #835

Anaheim, California, United States

ATP Clinical Research, Inc. Site #763

Costa Mesa, California, United States

Behavioral Research Specialists, LLC

Glendale, California, United States

Irvine Center for Clinical Research

Irvine, California, United States

Sheenath Clinical Service Site #770

Lakewood, California, United States

Torrance Clinical Research Institute, Inc. Site #826

Lomita, California, United States

Key Dates

Start Date

November 13, 2015

Primary Completion Date

September 6, 2024

Completion Date

September 6, 2024

Last Updated

October 15, 2025

Enrollment

1,197

ACTUAL participants

Conditions

Agitation in Patients With Dementia of the Alzheimer's Type

Interventions

AVP-786

DRUG

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

NCT03393520

Agitation in Patients With Dementia of the Alzheimer's Type

View study

COMPLETEDPHASE3

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

NCT04797715

Agitation in Patients With Dementia of the Alzheimer's TypeAlzheimer Disease+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

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