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

March 26, 2024 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess 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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Pernik, Bulgaria, 2300
        • Recruiting
        • Clinical Research Site #100-115
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Clinical Research Site #100-112
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Clinical Research Site
      • Sofia, Bulgaria, 1408
        • Recruiting
        • Clinical Research Site
      • Sofia, Bulgaria, 1408
        • Recruiting
        • Clinical Research Site #100-111
      • Varna, Bulgaria, 9020
        • Recruiting
        • Clinical Research Site #100-105
      • Varna, Bulgaria, 9020
        • Recruiting
        • Clinical Research Site #100-108
      • Veliko Tarnovo, Bulgaria, 5006
        • Recruiting
        • Clinical Research Site #100-113
  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Clinical Research Site
    • Region Nordjylland
      • Aalborg, Region Nordjylland, Denmark, 9000
        • Recruiting
        • Clinical Research Site # 208-001
  • Estonia
      • Tallinn, Estonia, 11315
        • Recruiting
        • Clinical Research Site #1
      • Tallinn, Estonia, 11315
        • Recruiting
        • Clinical Research Site #2
      • Tartu, Estonia, 50406
        • Recruiting
        • Clinical Research Site
  • Germany
      • Berlin, Germany, 13187
        • Recruiting
        • Clinical Research Site 276-014
      • Mittweida, Germany, 09648
        • Withdrawn
        • Clinical Research Site
      • Munich, Germany, 80336
        • Withdrawn
        • Clinical Research Site
      • Westerstede, Germany, 26655
        • Withdrawn
        • Clinical Research Site
    • Hessen
      • Bad Homburg Vor Der Höhe, Hessen, Germany, 61348
        • Withdrawn
        • Clinical Research Site
    • Thüringen
      • Gera, Thüringen, Germany, 935
        • Recruiting
        • Clinical Research Site #276-012
  • Greece
      • Athens, Greece, 15125
        • Recruiting
        • Clinical Research Site# 300-005
      • Athens, Greece, 11528
        • Withdrawn
        • Clinical Research Site #300-001
      • Ioannina, Greece, 45500
        • Recruiting
        • Clinical Research Site #300-006
      • Maroúsi, Greece, 15123
        • Withdrawn
        • Clinical Research Site #300-002
      • Thessaloníki, Greece, 54645
        • Recruiting
        • Clinical Research Site #300-003
  • Poland
      • Bydgoszcz, Poland, 85-163
        • Recruiting
        • Clinical Research Site
      • Kielce, Poland, 25-411
        • Recruiting
        • Clinical Research Site
      • Lublin, Poland, 20-064
        • Recruiting
        • Clinical Research Site
      • Lublin, Poland, 20-080
        • Recruiting
        • Clinical Research Site #616-010
      • Poznan, Poland, 60-369
        • Recruiting
        • Clinical Research Site
      • Poznan, Poland, 61-853
        • Recruiting
        • Clinical Research Site
      • Pruszcz Gdanski, Poland, 83-000
        • Recruiting
        • Clinical Research Site
      • Siemianowice Śląskie, Poland, 41-100
        • Withdrawn
        • Clinical Research Site #616-003
      • Warszawa, Poland, 01-737
        • Recruiting
        • Clinical Research Site
    • Kujawsko-Pomorskie
      • Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-023
        • Recruiting
        • Clinical Research Site
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-093
        • Recruiting
        • Clinical Research Site
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Clinical Research Site
      • Matosinhos, Portugal, 4520-211
        • Withdrawn
        • Clinical Research Site #620-001
      • Torres Vedras, Portugal, 2560-280
        • Recruiting
        • Clinical Research Site
    • Aveiro
      • Santa Maria Da Feira, Aveiro, Portugal, 4520-211
        • Withdrawn
        • Clinical Research Site
    • Braga
      • Guimarães, Braga, Portugal, 4835-044
        • Recruiting
        • Clinical Research Site #620-007
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Recruiting
        • Clinical Research Site
      • Rio Piedras, Puerto Rico, 00935
        • Active, not recruiting
        • Clinical Research Site #630-003
      • San Juan, Puerto Rico, 926
        • Recruiting
        • Clinical Research Site #630-005
      • San Juan, Puerto Rico, 00918
        • Active, not recruiting
        • Clinical Research Site #630-002
  • Ukraine
      • Dnipro, Ukraine, 49005
        • Active, not recruiting
        • Clinical Research Site #804-006
      • Kharkiv, Ukraine, 61068
        • Active, not recruiting
        • Clinical Research Site #804-003
      • Kiev, Ukraine, 8631
        • Active, not recruiting
        • Clinical Research Site #804-004
      • Kyiv, Ukraine, 04080
        • Active, not recruiting
        • Clinical Research Site #804-005
      • Lviv, Ukraine, 79021
        • Active, not recruiting
        • Clinical Research Site #804-007
  • United Kingdom
      • Aylesbury, United Kingdom, HP18 0LX
        • Withdrawn
        • Clinical Research Site #826-007
      • Blandford Forum, United Kingdom, DT11 7DD
        • Recruiting
        • Clinical Research Site
      • Crowborough, United Kingdom, TN61NY
        • Recruiting
        • Clinical Research Site
      • Fulwood, United Kingdom, PR2 9HT
        • Recruiting
        • Clinical Research Site
      • Manchester, United Kingdom, M25 3BL
        • Recruiting
        • Clinical Research Site# 826-006
      • Motherwell, United Kingdom, ML1 4UF
        • Recruiting
        • Clinical Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Active, not recruiting
        • Clinical Research Site #840-053
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Recruiting
        • Clinical Research Site #840-081
      • Little Rock, Arkansas, United States, 72209
        • Withdrawn
        • Clinical Research Site
      • Little Rock, Arkansas, United States, 72205
        • Withdrawn
        • Clinical Research Site #840-013
    • California
      • Irvine, California, United States, 92697
        • Withdrawn
        • Clinical Research Site
      • La Jolla, California, United States, 92093
        • Recruiting
        • Clinical Research Site
      • Oceanside, California, United States, 92056
        • Active, not recruiting
        • Clinical Research Site #840-050
      • Pasadena, California, United States, 91105
        • Recruiting
        • Clinical Research Site #840-064
    • Colorado
      • Basalt, Colorado, United States, 81621
        • Recruiting
        • Clinical Research Site #840-090
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • Clinical Research Site
      • Brandon, Florida, United States, 33511
        • Active, not recruiting
        • Clinical Research Site #840-056
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Clinical Research Site
      • Doral, Florida, United States, 33166
        • Recruiting
        • Clinical Research Site
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Clinical Research Site
      • Kissimmee, Florida, United States, 34744
        • Active, not recruiting
        • Clinical Research Site #840-012
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Clinical Research Site #840-069
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Clinical Research Site #840-083
      • Miami, Florida, United States, 33126
        • Recruiting
        • Clinical Research Site
      • Miami, Florida, United States, 33176
        • Withdrawn
        • Clinical Research Site
      • Miami, Florida, United States, 33467
        • Recruiting
        • Clinical Research Site
      • Miami, Florida, United States, 33032
        • Recruiting
        • Clinical Research Site #840-118
      • Miami, Florida, United States, 33175
        • Active, not recruiting
        • Clinical Research Site #840-042
      • Orlando, Florida, United States, 32819
        • Recruiting
        • Clinical Research Site
      • Palm Beach Gardens, Florida, United States, 33410
        • Withdrawn
        • Clinical Research Site #840-041
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • Clinical Research Site 840-111
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Clinical Research Site #840-096
      • Pompano Beach, Florida, United States, 33064
        • Active, not recruiting
        • Clinical Research Site
      • Tampa, Florida, United States, 33609
        • Withdrawn
        • Clinical Research Site
      • Tampa, Florida, United States, 33613
        • Withdrawn
        • Clinical Research Site
      • Tampa, Florida, United States, 33634
        • Active, not recruiting
        • Clinical Research Site #840-046
      • Tampa, Florida, United States, 33614
        • Active, not recruiting
        • Clinical Research Site #840-079
      • Tampa, Florida, United States, 33615
        • Recruiting
        • Clinical Research Site #840-112
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Withdrawn
        • Clinical Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Withdrawn
        • Clinical Research Site # 840-001
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Clinical Research Site #840-049
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Recruiting
        • Clinical Research Site #840-093
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Active, not recruiting
        • Clinical Research Site #840-015
    • New Jersey
      • Mount Arlington, New Jersey, United States, 07856
        • Withdrawn
        • Clinical Research Site #840-033
      • West Long Branch, New Jersey, United States, 07764
        • Active, not recruiting
        • Clinical Research Site #840-029
    • New York
      • Bronx, New York, United States, 10466
        • Recruiting
        • Clinical Research Site #840-097
      • New Windsor, New York, United States, 12553
        • Active, not recruiting
        • Clinical Research Site #840-072
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Clinical Research Site #840-095
      • Winston-Salem, North Carolina, United States, 27157
        • Withdrawn
        • Clinical Research Site #840-030
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Clinical Research Site
      • Columbus, Ohio, United States, 43210
        • Active, not recruiting
        • Clinical Research Site #840-028
      • Dayton, Ohio, United States, 45459
        • Withdrawn
        • Clinical Research Site
      • Westerville, Ohio, United States, 43082
        • Withdrawn
        • Clinical Research Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73012
        • Active, not recruiting
        • Clinical Research Site #840-061
      • Oklahoma City, Oklahoma, United States, 73106
        • Withdrawn
        • Clinical Research Site
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Clinical Research Site #840-099
    • Pennsylvania
      • Moosic, Pennsylvania, United States, 18507
        • Withdrawn
        • Clinical Research Site #840-018
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Withdrawn
        • Clinical Research Site #840-043
    • Texas
      • The Woodlands, Texas, United States, 77381
        • Active, not recruiting
        • Clinical Research Site
    • Virginia
      • Richmond, Virginia, United States, 23236
        • Active, not recruiting
        • Clinical Research Site #840-025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Time Frame: Baseline; Week 12
Baseline; Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation
Time Frame: Baseline; Week 12
Baseline; Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-AVP-786-306
  • 2020-000798-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing

IPD Sharing Time Frame

Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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