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Agitation in Patients With Dementia of the Alzheimer's TypePhase 3NCT04408755

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

A Phase 3 study testing AVP-786 in people with Agitation in Patients With Dementia of the Alzheimer's Type, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 95 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study was 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. Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
AVP-786
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
184 participants
Where
95 sitesin 11 countries
Study dates
13 Jul 2020to 27 Jun 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

95 sites in 11 countries.

95 sites in 11 countries

United States45 sites

  • Clinical Research Site #840-009

    Atlantis, Florida, 33462

  • Clinical Research Site #840-090

    Basalt, Colorado, 81621

  • Clinical Research Site #840-056

    Brandon, Florida, 33511

  • Clinical Research Site #840-060

    Canton, Ohio, 44718

  • Clinical Research Site #840-028

    Columbus, Ohio, 43210

  • Clinical Research Site #840-020

    Coral Gables, Florida, 33134

  • Clinical Research Site #840-059

    Doral, Florida, 33166

  • Clinical Research Site #840-061

    Edmond, Oklahoma, 73012

  • Clinical Research Site #840-081

    Fort Smith, Arkansas, 72901

  • Clinical Research Site #840-049

    Glen Burnie, Maryland, 21061

  • Clinical Research Site #840-015

    Hattiesburg, Mississippi, 39401

  • Clinical Research Site #840-131

    Hialeah, Florida, 33012

  • Clinical Research Site #840-039

    Jacksonville, Florida, 32256

  • Clinical Research Site #840-012

    Kissimmee, Florida, 34744

  • Clinical Research Site #840-035

    La Jolla, California, 92093

  • Clinical Research Site #840-084

    Los Angeles, California, 70072

  • Clinical Research Site #840-069

    Maitland, Florida, 32751

  • Clinical Research Site #840-083

    Maitland, Florida, 32751

  • Clinical Research Site #840-115

    McKinney, Texas, 75069

  • Clinical Research Site #840-118

    Miami, Florida, 33032

  • Clinical Research Site #840-004

    Miami, Florida, 33126

  • Clinical Research Site #840-125

    Miami, Florida, 33126

  • Clinical Research Site #840-104

    Miami, Florida, 33144

  • Clinical Research Site #840-133

    Miami, Florida, 33165

  • Clinical Research Site #840-042

    Miami, Florida, 33175

  • Clinical Research Site #840-003

    Miami, Florida, 33467

  • Clinical Research Site #840-095

    Monroe, North Carolina, 28112

  • Clinical Research Site #840-072

    New Windsor, New York, 12553

  • Clinical Research Site #840-050

    Oceanside, California, 92056

  • Clinical Research Site #840-036

    Orlando, Florida, 32819

  • Clinical Research Site #840-064

    Pasadena, California, 91105

  • Clinical Research Site 840-111

    Pembroke Pines, Florida, 33024

  • Clinical Research Site #840-096

    Pensacola, Florida, 32503

  • Clinical Research Site

    Pompano Beach, Florida, 33064

  • Clinical Research Site #840-025

    Richmond, Virginia, 23236

  • Clinical Research Site #840-093

    Rochester Hills, Michigan, 48307

  • Clinical Research Site #840-098

    Santa Ana, California, 92705

  • Clinical Research Site #840-079

    Tampa, Florida, 33614

  • Clinical Research Site #840-112

    Tampa, Florida, 33615

  • Clinical Research Site #840-046

    Tampa, Florida, 33634

  • Clinical Research Site #840-097

    The Bronx, New York, 10466

  • Clinical Research Site

    The Woodlands, Texas, 77381

  • Clinical Research Site #840-099

    Tulsa, Oklahoma, 74136

  • Clinical Research Site #840-029

    West Long Branch, New Jersey, 07764

  • Clinical Research Site #840-107

    West Palm Beach, Florida, 33407

Other trials in United States

Poland12 sites

  • Clinical Research Site #616-009

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-023

  • Clinical Research Site #616-013

    Bydgoszcz, 85-163

  • Clinical Research Site #616-004

    Kielce, 25-411

  • Clinical Research Site #616-006

    Lublin, Lublin Voivodeship, 20-093

  • Clinical Research Site #616-008

    Lublin, 20-064

  • Clinical Research Site #616-010

    Lublin, 20-080

  • Clinical Research Site #616-012

    Poznan, 60-369

  • Clinical Research Site #616-005

    Poznan, 61-853

  • Clinical Research Site #616-001

    Pruszcz Gdański, 83-000

  • Clinical Research Site #616-015

    Sochaczew, Masovian Voivodeship, 96-500

  • Clinical Research Site #616-007

    Warsaw, 01-737

  • Clinical Research Site #616-018

    Zabrze, Katowice, 41-807

Other trials in Poland

Bulgaria8 sites

  • Clinical Research Site #100-115

    Pernik, 2300

  • Clinical Research Site #100-112

    Pleven, 5800

  • Clinical Research Site #100-106

    Plovdiv, 4002

  • Clinical Research Site #100-102

    Sofia, 1408

  • Clinical Research Site #100-111

    Sofia, 1408

  • Clinical Research Site #100-105

    Varna, 9020

  • Clinical Research Site #100-108

    Varna, 9020

  • Clinical Research Site #100-113

    Veliko Tarnovo, 5006

Other trials in Bulgaria

Ukraine5 sites

  • Clinical Research Site #804-006

    Dnipro, 49005

  • Clinical Research Site #804-003

    Kharkiv, 61068

  • Clinical Research Site #804-004

    Kiev, 8631

  • Clinical Research Site #804-005

    Kyiv, 04080

  • Clinical Research Site #804-007

    Lviv, 79021

Other trials in Ukraine

United Kingdom5 sites

  • Clinical Research Site #826-003

    Blandford Forum, DT11 7DD

  • Clinical Research Site #826-004

    Crowborough, TN61NY

  • Clinical Research Site #826-001

    Fulwood, PR2 9HT

  • Clinical Research Site# 826-006

    Manchester, M25 3BL

  • Clinical Research Site #826-002

    Motherwell, ML1 4UF

Other trials in United Kingdom

Germany4 sites

  • Clinical Research Site #276-005

    Bad Homburg, Hesse, 61348

  • Clinical Research Site 276-014

    Berlin, 13187

  • Clinical Research Site #276-017

    Böblingen, Baden-Wurttemberg, 71034

  • Clinical Research Site #276-012

    Gera, Thuringia, 935

Other trials in Germany

Portugal4 sites

  • Clinical Research Site #620-004

    Braga, 4710-243

  • Clinical Research Site #620-005

    Coimbra, 3000-075

  • Clinical Research Site #620-007

    Guimarães, Braga District, 4835-044

  • Clinical Research Site #620-002

    Torres Vedras, 2560-280

Other trials in Portugal

Puerto Rico4 sites

  • Clinical Research Site #630-001

    Bayamón, 00961

  • Clinical Research Site #630-003

    Rio Piedras, 00935

  • Clinical Research Site #630-002

    San Juan, 00918

  • Clinical Research Site #630-005

    San Juan, 926

Other trials in Puerto Rico

Estonia3 sites

  • Clinical Research Site #1 Site #233-002

    Tallinn, 11315

  • Clinical Research Site #2 Site #233-004

    Tallinn, 11315

  • Clinical Research Site #233-001

    Tartu, 50406

Other trials in Estonia

Greece3 sites

  • Clinical Research Site# 300-005

    Athens, 15125

  • Clinical Research Site #300-006

    Ioannina, 45500

  • Clinical Research Site #300-003

    Thessaloniki, 54645

Other trials in Greece

Denmark2 sites

  • Clinical Research Site # 208-001

    Aalborg, North Denmark, 9000

  • Clinical Research Site #208-002

    Aalborg, 9000

Other trials in Denmark

About this study

Official title: 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 was 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.

Read the detailed description

Eligible participants for this study had a diagnosis of probable Alzheimer's disease (AD) and had clinically significant, moderate/severe agitation secondary to AD.

This was a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Screening occurred within 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were randomized into the study.

184 participants were enrolled into the study.

Study medication was administered orally twice daily from Day 1 through Day 85.

Being tested
AVP-786, Placebo
Keywords
Agitation, Dementia of the Alzheimer's type, Alzheimer's disease, AVP-786, Deudextromethorphan hydrobromide, Quinidine sulfate
Medical subject headings
Psychomotor Agitation, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVP-786Drug

    oral capsules

  • PlaceboDrug

    oral capsules

Study groups in NCT04408755
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786 matching placebo capsules, twice a day, for 11 weeks in Period B.
Receives: Drug: Placebo
AVP-786-18ExperimentalParticipants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786-18 (d6-DM 18 milligrams (mg)/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.
Receives: Drug: AVP-786
AVP-786-42.63ExperimentalParticipants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.
Receives: Drug: AVP-786

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From the End of Period A (Week 1) to Week 10 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score

    The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = once or twice a week, 4 = several times a week, 5 = once or twice a day, 6 = several times a day, 7 = several times an hour). The ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviours while lower scores indicate lower frequency of agitated behaviours.

    Measured: Week 1 to Week 10

  2. Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE

    An adverse event (AE) is any untoward medical occurrence or unintended change (eg, physical, psychological, or behavioral), including inter-current illness, that does not necessarily have a causal relationship with the study treatment. A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongation of hospitalization or congenital anomaly/birth defect. TEAEs are all AEs (including serious and non-serious) which started after start of double-blind study drug treatment; or if the event was continuous from baseline and was worsening, serious, study drug related, or resulted in death, discontinuation, interruption or reduction of study therapy.

    Measured: From randomization (Week 2) up to 30 days after last dose of study drug (Up to Week 16)

Secondary outcomes (1)

  1. Change From the End of Period A (Week 1) to Week 10 in the Clinical Global Impression of Severity of Illness (CGIS) Score, as Related to Agitation

    The CGIS is an observer-rated scale that measures illness severity. The CGIS-Agitation is a 7-point (1-7) scale (1 = normal, not at all ill; 7 = among the most extremely ill patients) and assesses severity of agitation in this study. Higher scores indicate severe agitation while the lower scores indicate little or no agitation.

    Measured: Week 1 to Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start13 Jul 2020
  3. Primary completion27 Jun 2024
  4. Study completion27 Jun 2024

Why it stopped: The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04408755
Sponsor's protocol ID
20-AVP-786-306
Other IDs
2020-000798-26, 2023-504990-19-00, 2023
Status last verified
May 2025
First submitted
26 May 2020
Last updated
30 May 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AVP-786 in people with Agitation in Patients With Dementia of the Alzheimer's Type, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 95 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Poland, Bulgaria, Ukraine, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From the End of Period A (Week 1) to Week 10 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score (time frame: Week 1 to Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04408755.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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