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Agitation in Patients With Dementia of the Alzheimer's TypePhase 3NCT04464564

Study to Assess 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 106 sites in 13 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
241 participants
Where
106 sitesin 13 countries
Study dates
11 Sep 2020to 28 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

106 sites in 13 countries.

106 sites in 13 countries

United States46 sites

  • Clinical Research Site #840-047

    Anaheim, California, 92805

  • Clinical Research Site #840-070

    Apopka, Florida, 32703

  • Clinical Research Site #840-065

    Atlanta, Georgia, 30318

  • Clinical Research Site #840-014

    Bloomfield Township, Michigan, 48302

  • Clinical Research Site #840-073

    Boston, Massachusetts, 02131

  • Clinical Research Site #840-055

    Bradenton, Florida, 34205

  • Clinical Research Site #840-031

    Buffalo, New York, 14030

  • Clinical Research Site #840-096

    Cape Coral, Florida, 33904

  • Clinical Research Site #840-030

    Chicago, Illinois, 60637

  • Clinical Research Site #840-077

    Clermont, Florida, 34771

  • Clinical Research Site #840-066

    Coral Springs, Florida, 33067

  • Clinical Research Site #840-090

    Costa Mesa, California, 92626

  • Clinical Research Site #840-035

    Cypress, Texas, 77429

  • Clinical Research Site #840-053

    Dallas, Texas, 75206

  • Clinical Research Site #840-022

    Detroit, Michigan, 48201

  • Clinical Research Site #840-093

    El Paso, Texas, 79902

  • Clinical Research Site #840-044

    Fairfax, Virginia, 22031

  • Clinical Research Site #840-039

    Hallandale, Florida, 33009

  • Clinical Research Site #840-072

    Houston, Texas, 77063

  • Clinical Research Site #840-057

    Houston, Texas, 77077

  • Clinical Research Site #840-089

    Kissimmee, Florida, 34741

  • Clinical Research Site #840-034

    Lady Lake, Florida, 32159

  • Clinical Research Site #840-059

    Lafayette, California, 94549

  • Clinical Research Site #840-048

    Lomita, California, 90717

  • Clinical Research Site #840-095

    Long Beach, California, 90807

  • Clinical Research Site #840-004

    Los Angeles, California, 90024

  • Clinical Research Site #840-021

    Manhasset, New York, 11030

  • Clinical Research Site #840-086

    Mesquite, Texas, 75149

  • Clinical Research Site #840-037

    Miami, Florida, 33122

  • Clinical Research Site #840-092

    Miami, Florida, 33125

  • Clinical Research Site #840-041

    Miami, Florida, 33126

  • Clinical Research Site #840-007

    Miami, Florida, 33145

  • Clinical Research Site #840-103

    Miami, Florida, 33175

  • Clinical Research Site #840-042

    Miami, Florida, 33176

  • Clinical Research Site #840-051

    Naples, Florida, 34105

  • Clinical Research Site #840-058

    New Hyde Park, New York, 11040

  • Clinical Research Site #840-024

    O'Fallon, Missouri, 63368

  • Clinical Research Site #840-087

    Orlando, Florida, 32807

  • Clinical Research Site #840-006

    Panorama City, California, 91402

  • Clinical Research Site 840-028

    Pensacola, Florida, 32502

  • Clinical Research Site #840-020

    Phoenix, Arizona, 85004

  • Clinical Research Site

    San Diego, California, 92128

  • Clinical Research Site # 840-105

    Tampa, Florida, 33614

  • Clinical Research Site #840-104

    Tampa, Florida, 33614

  • Clinical Research Site #840-049

    West Palm Beach, Florida, 33407

  • Clinical Research Site #840-036

    Winter Park, Florida, 32789

Other trials in United States

Mexico8 sites

  • Clinical Research Site #484-008

    Mérida, 97070

  • Clinical Research Site # 484-004

    Mexico City, 7000

  • Clinical Research Site #484-006

    Monterrey, 64310

  • Clinical Research Site #484-005

    Monterrey, 64460

  • Clinical Research Site # 484-003

    Monterrey, 64710

  • Clinical Research Site #484-010

    Saltillo, 25020

  • Clinical Research Site # 484-002

    Sinaloa, 80020

  • Clinical Research Site #484-009

    Tlalnepantla, 54055

Other trials in Mexico

Slovakia7 sites

  • Clinical Research Site #703-006

    Banská Bystrica, 97404

  • Clinical Research Site #703-002

    Bardejov, 08501

  • Clinical Research Site #703-009

    Dubnica Nad Váhom, Bratislava Region, 01851

  • Clinical Research Site #703-005

    Košice, 04001

  • Clinical Research Site #703-104

    Rimavská Sobota, Sobota, 97901

  • Clinical Research Site #703-003

    Trenčín, 91108

  • Clinical Research Site #703-001

    Vranov nad Topľou, 09301

Other trials in Slovakia

Chile6 sites

  • Clinical Research Site #152-002

    Antofagasta, 1270244

  • Clinical Research Site #152-005

    Independencia, 8380456

  • Clinical Research Site #152-001

    Santiago, 7500710

  • Clinical Research Site #152-003

    Santiago, 7560356

  • Clinical Research Site #152-006

    Santiago, 9120000

  • Clinical Research Site #152-007

    Viña Del Mar, Santiago Metropolitan, 2451029

Other trials in Chile

Colombia6 sites

  • Clinical Research Site #170-006

    Bello, 051050

  • Clinical Research Site #170-003

    Bogotá, Columbia, 111166

  • Clinical Research Site #170-001

    Bogotá, 110231

  • Clinical Research Site #170-004

    Bogotá, 110231

  • Clinical Research Site #170-007

    Floridablanca, Santander Department, 111511

  • Clinical Research Site #170-002

    Pereira, Columbia, 1111

Other trials in Colombia

Croatia6 sites

  • Clinical Research Site #191-008

    Pula, Istria County, 52000

  • Clinical Research Site# 191-006

    Rijeka, 51000

  • Clinical Research Site# 191-001

    Zagreb, 10000

  • Clinical Research Site #191-003

    Zagreb, 1000

  • Clinical Research Site #191-005

    Zagreb, HR 10000

  • Clinical Research Site #191-002

    Zagreb, HR-10090

Other trials in Croatia

Slovenia6 sites

  • Clinical Research Site #705-004

    Begunje na Gorenjskem, 4275

  • Clinical Research Site #705-003

    Ljubljana, 1000

  • Clinical Research Site #705-002

    Ljubljana, 1260

  • Clinical Research Site #705-005

    Maribor, 2000

  • Clinical Research Site #705-006

    Murska Sobota, Municipality of Brezovica, 9000

  • Clinical Research Site #705-001

    Nova Gorica, 52905000

Other trials in Slovenia

Spain6 sites

  • Clinical Research Site #724-012

    Alicante, Valenciana, Comunitat, 03010

  • Clinical Research Site # 724-007

    Coslada, 28882

  • Clinical Research Site #724-009

    Madrid, 28006

  • Clinical Research Site #724-006

    Madrid, 28049

  • Clinical Research Site #724-011

    Palma de Mallorca, Balearic Islands, 07120

  • Clinical Research Site #724-013

    Seville, Andalusia, 41013

Other trials in Spain

Belgium4 sites

  • Clinical Research Site #056-005

    Alken, Limburg, 3570

  • Clinical Research Site #056-004

    Brussels, 1070

  • Clinical Research Site #056-003

    Leuven, 3000

  • Clinical Research Site # 056-002

    Liège, 4000

Other trials in Belgium

Hungary4 sites

  • Clinical Research Site #384-001

    Budapest, 1036

  • Clinical Research Site #384-003

    Budapest, 1036

  • Clinical Research Site #348-002

    Gyöngyös, Heves County, 3200

  • Clinical Research Site #348-004

    Zalaegerszeg, 8900

Other trials in Hungary

Ireland4 sites

  • Clinical Research Site #372-002

    Cork, T12 WE28

  • Clinical Research Site #372-003

    Cork, T12 XH60

  • Clinical Research Site #372-004

    Dublin, 24

  • Clinical Research Site #372-001

    Dublin, D08 E191

Other trials in Ireland

Canada2 sites

  • Clinical Research Site #124-003

    Kelowna, British Columbia, V1Y 1Z9

  • Clinical Research Site #124-008

    Québec, Quebec, G3K 2P8

Other trials in Canada

Netherlands1 site

  • Clinical Trial Site #528-001

    Amsterdam, 1081GN

Other trials in Netherlands

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 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.

241 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 NCT04464564
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 posted9 Jul 2020
  2. Study start11 Sep 2020
  3. Primary completion28 Jun 2024
  4. Study completion28 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
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04464564
Sponsor's protocol ID
20-AVP-786-307
Other IDs
2020-000799-39, 2023-504991-31-00, 2023
Status last verified
May 2025
First submitted
6 Jul 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 106 sites in 13 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 106 sites in United States, Mexico, Slovakia, Chile, Colombia and 8 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 NCT04464564.

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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