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

Agitation in Patients With Dementia of the Alzheimer's Type Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04408755
• Other study ID #: 20-AVP-786-306
• Secondary ID: 2020-000798-26
• Status: Recruiting
• Phase: Phase 3
• Start date: July 8, 2020
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: Otsuka Call Center
• Phone: 844-687-8522
• Email: OtsukaRMReconciliation[@]rmpdc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation in Patients With Dementia of the Alzheimer's Type
• Alzheimer Disease
• Dementia
• Psychomotor Agitation

Intervention

Drug:
• AVP-786
oral capsules
• Placebo
oral capsules

Locations

Country	Name	City	State
Bulgaria	Clinical Research Site #100-115	Pernik
Bulgaria	Clinical Research Site #100-112	Pleven
Bulgaria	Clinical Research Site	Plovdiv
Bulgaria	Clinical Research Site	Sofia
Bulgaria	Clinical Research Site #100-111	Sofia
Bulgaria	Clinical Research Site #100-105	Varna
Bulgaria	Clinical Research Site #100-108	Varna
Bulgaria	Clinical Research Site #100-113	Veliko Tarnovo
Denmark	Clinical Research Site	Aalborg
Denmark	Clinical Research Site # 208-001	Aalborg	Region Nordjylland
Estonia	Clinical Research Site #1	Tallinn
Estonia	Clinical Research Site #2	Tallinn
Estonia	Clinical Research Site	Tartu
Germany	Clinical Research Site #276-005	Bad Homburg Vor Der Höhe	Hessen
Germany	Clinical Research Site 276-014	Berlin
Germany	Clinical Research Site #276-017	Böblingen	Baden-Württemberg
Germany	Clinical Research Site #276-012	Gera	Thüringen
Germany	Clinical Research Site	Mittweida
Germany	Clinical Research Site	Munich
Germany	Clinical Research Site	Westerstede
Greece	Clinical Research Site #300-001	Athens
Greece	Clinical Research Site# 300-005	Athens
Greece	Clinical Research Site #300-006	Ioannina
Greece	Clinical Research Site #300-002	Maroúsi
Greece	Clinical Research Site #300-003	Thessaloníki
Poland	Clinical Research Site	Bydgoszcz	Kujawsko-Pomorskie
Poland	Clinical Research Site	Bydgoszcz
Poland	Clinical Research Site	Kielce
Poland	Clinical Research Site	Lublin
Poland	Clinical Research Site	Lublin	Lubelskie
Poland	Clinical Research Site #616-010	Lublin
Poland	Clinical Research Site	Poznan
Poland	Clinical Research Site	Poznan
Poland	Clinical Research Site	Pruszcz Gdanski
Poland	Clinical Research Site #616-003	Siemianowice Slaskie
Poland	Clinical Research Site #616-015	Sochaczew	Mazowieckie
Poland	Clinical Research Site	Warszawa
Portugal	Clinical Research Site	Braga
Portugal	Clinical Research Site #620-007	Guimarães	Braga
Portugal	Clinical Research Site #620-001	Matosinhos
Portugal	Clinical Research Site	Santa Maria Da Feira	Aveiro
Portugal	Clinical Research Site	Torres Vedras
Puerto Rico	Clinical Research Site	Bayamon
Puerto Rico	Clinical Research Site #630-003	Rio Piedras
Puerto Rico	Clinical Research Site #630-002	San Juan
Puerto Rico	Clinical Research Site #630-005	San Juan
Ukraine	Clinical Research Site #804-006	Dnipro
Ukraine	Clinical Research Site #804-003	Kharkiv
Ukraine	Clinical Research Site #804-004	Kiev
Ukraine	Clinical Research Site #804-005	Kyiv
Ukraine	Clinical Research Site #804-007	Lviv
United Kingdom	Clinical Research Site #826-007	Aylesbury
United Kingdom	Clinical Research Site	Blandford Forum
United Kingdom	Clinical Research Site	Crowborough
United Kingdom	Clinical Research Site	Fulwood
United Kingdom	Clinical Research Site# 826-006	Manchester
United Kingdom	Clinical Research Site	Motherwell
United States	Clinical Research Site	Atlantis	Florida
United States	Clinical Research Site #840-090	Basalt	Colorado
United States	Clinical Research Site #840-053	Birmingham	Alabama
United States	Clinical Research Site #840-056	Brandon	Florida
United States	Clinical Research Site #840-097	Bronx	New York
United States	Clinical Research Site	Canton	Ohio
United States	Clinical Research Site #840-028	Columbus	Ohio
United States	Clinical Research Site	Coral Gables	Florida
United States	Clinical Research Site #840-043	Cordova	Tennessee
United States	Clinical Research Site	Dayton	Ohio
United States	Clinical Research Site	Doral	Florida
United States	Clinical Research Site #840-061	Edmond	Oklahoma
United States	Clinical Research Site #840-081	Fort Smith	Arkansas
United States	Clinical Research Site #840-049	Glen Burnie	Maryland
United States	Clinical Research Site #840-015	Hattiesburg	Mississippi
United States	Clinical Research Site # 840-001	Honolulu	Hawaii
United States	Clinical Research Site	Irvine	California
United States	Clinical Research Site	Jacksonville	Florida
United States	Clinical Research Site #840-012	Kissimmee	Florida
United States	Clinical Research Site	La Jolla	California
United States	Clinical Research Site	Little Rock	Arkansas
United States	Clinical Research Site #840-013	Little Rock	Arkansas
United States	Clinical Research Site #840-069	Maitland	Florida
United States	Clinical Research Site #840-083	Maitland	Florida
United States	Clinical Research Site #840-115	McKinney	Texas
United States	Clinical Research Site	Miami	Florida
United States	Clinical Research Site	Miami	Florida
United States	Clinical Research Site	Miami	Florida
United States	Clinical Research Site #840-042	Miami	Florida
United States	Clinical Research Site #840-118	Miami	Florida
United States	Clinical Research Site #840-095	Monroe	North Carolina
United States	Clinical Research Site #840-018	Moosic	Pennsylvania
United States	Clinical Research Site #840-033	Mount Arlington	New Jersey
United States	Clinical Research Site #840-072	New Windsor	New York
United States	Clinical Research Site	Newnan	Georgia
United States	Clinical Research Site #840-050	Oceanside	California
United States	Clinical Research Site	Oklahoma City	Oklahoma
United States	Clinical Research Site	Orlando	Florida
United States	Clinical Research Site #840-041	Palm Beach Gardens	Florida
United States	Clinical Research Site #840-064	Pasadena	California
United States	Clinical Research Site 840-111	Pembroke Pines	Florida
United States	Clinical Research Site #840-096	Pensacola	Florida
United States	Clinical Research Site	Pompano Beach	Florida
United States	Clinical Research Site #840-025	Richmond	Virginia
United States	Clinical Research Site #840-093	Rochester Hills	Michigan
United States	Clinical Research Site #840-098	Santa Ana	California
United States	Clinical Research Site	Tampa	Florida
United States	Clinical Research Site	Tampa	Florida
United States	Clinical Research Site #840-046	Tampa	Florida
United States	Clinical Research Site #840-079	Tampa	Florida
United States	Clinical Research Site #840-112	Tampa	Florida
United States	Clinical Research Site	The Woodlands	Texas
United States	Clinical Research Site #840-099	Tulsa	Oklahoma
United States	Clinical Research Site #840-029	West Long Branch	New Jersey
United States	Clinical Research Site #840-107	West Palm Beach	Florida
United States	Clinical Research Site	Westerville	Ohio
United States	Clinical Research Site #840-030	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Denmark,  Estonia,  Germany,  Greece,  Poland,  Portugal,  Puerto Rico,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score		Baseline; Week 12
Secondary	Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation		Baseline; Week 12