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

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: NCT04464564
• Other study ID #: 20-AVP-786-307
• Secondary ID: 2020-000799-39
• Status: Recruiting
• Phase: Phase 3
• Start date: September 3, 2020
• Est. completion date: November 30, 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: November 30, 2026
• Est. primary completion date: August 31, 2026
• 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
Belgium	Clinical Research Site #056-005	Alken	Limburg
Belgium	Clinical Research Site #056-004	Brussel
Belgium	Clinical Research Site #056-003	Leuven
Belgium	Clinical Research Site # 056-002	Liège
Canada	Clinical Research Site	Kelowna	British Columbia
Canada	Clinical Research Site	Montreal	Quebec
Canada	Clinical Research Site	Quebec City	Quebec
Canada	Clinical Research Site #124-007	Sarnia	Ontario
Canada	Clinical Research Site #124-002	Sherbrooke	Quebec
Chile	Clinical Research Site #152-002	Antofagasta
Chile	Clinical Research Site # 152-005	Independencia
Chile	Clinical Research Site #152-003	Santiago
Chile	Clinical Research Site #152-001	Santiago de Chile
Chile	Clinical Research Site #152-006	Santiago de Chile
Colombia	Clinical Research Site	Bello
Colombia	Clinical Research Site	Bogota
Colombia	Clinical Research Site	Bogota	Columbia
Colombia	Clinical Research Site	Bogotá
Colombia	Clinical Research Site	Florida Blanca	Santander
Colombia	Clinical Research Site	Pereira	Columbia
Croatia	Clinical Research Site #191-008	Pula	Istarska Županija
Croatia	Clinical Research Site# 191-006	Rijeka
Croatia	Clinical Research Site #191-002	Zagreb
Croatia	Clinical Research Site #191-003	Zagreb
Croatia	Clinical Research Site #191-004	Zagreb
Croatia	Clinical Research Site #191-005	Zagreb
Croatia	Clinical Research Site# 191-001	Zagreb
Hungary	Clinical Research Site #1	Budapest
Hungary	Clinical Research Site #2	Budapest
Hungary	Clinical Research Site	Gyöngyös	Heves
Hungary	Clinical Research Site #348-004	Zalaegerszeg
Ireland	Clinical Research Site #372-002	Cork
Ireland	Clinical Research Site #372-003	Cork
Ireland	Clinical Research Site #372-001	Dublin
Ireland	Clinical Research Site #372-004	Dublin
Mexico	Clinical Research Site #484-008	Merida
Mexico	Clinical Research Site # 484-004	Mexico City
Mexico	Clinical Research Site # 484-003	Monterrey
Mexico	Clinical Research Site #484-005	Monterrey
Mexico	Clinical Research Site #484-006	Monterrey
Mexico	Clinical Research Site #484-010	Saltillo
Mexico	Clinical Research Site # 484-002	Sinaloa
Mexico	Clinical Research Site #484-009	Tlalnepantla
Netherlands	Clinical Trial Site #528-001	Amsterdam
Slovakia	Clinical Research Site #703-006	Banská Bystrica
Slovakia	Clinical Research Site	Bardejov
Slovakia	Clinical Research Site #703-009	Dubnica Nad Váhom	Bratislavský Kraj
Slovakia	Clinical Research Site #703-005	Košice
Slovakia	Clinical Research Site	Rimavska Sobota	Sobota
Slovakia	Clinical Research Site	Trencin
Slovakia	Clinical Research Site	Vranov Nad Toplou
Slovenia	Clinical Research Site	Begunje na Gorenjskem
Slovenia	Clinical Research Site	Ljubljana
Slovenia	Clinical Research Site	Ljubljana
Slovenia	Clinical Research Site #705-005	Maribor
Slovenia	Clinical Research Site #705-006	Murska Sobota	Brezovica
Slovenia	Clinical Research Site #705-001	Nova Gorica
Spain	Clinical Research Site #724-012	Alicante	Valenciana, Comunitat
Spain	Clinical Research Site #724-010	Burgos
Spain	Clinical Research Site # 724-007	Coslada
Spain	Clinical Research Site	Madrid
Spain	Clinical Research Site	Madrid
Spain	Clinical Research Site #724-001	Oviedo	Asturias
Spain	Clinical Research Site #724-011	Palma De Mallorca	Baleares
Spain	Clinical Research Site #724-003	Sant Cugat del Vallès
Spain	Clinical Research Site #724-013	Seville	Andalucía
Spain	Clinical Research Site #724-004	Terrassa
United States	Clinical Research Site #840-017	Alexandria	Virginia
United States	Clinical Research Site #840-047	Anaheim	California
United States	Clinical Research Site #840-070	Apopka	Florida
United States	Clinical Research Site	Atlanta	Georgia
United States	Clinical Research Site #840-014	Bloomfield Township	Michigan
United States	Clinical Research Site #840-073	Boston	Massachusetts
United States	Clinical Research Site #840-055	Bradenton	Florida
United States	Clinical Research Site	Buffalo	New York
United States	Clinical Research Site #840-096	Cape Coral	Florida
United States	Clinical Research Site #840-030	Chicago	Illinois
United States	Clinical Research Site #840-077	Clermont	Florida
United States	Clinical Research Site #840-066	Coral Springs	Florida
United States	Clinical Research Site #840-090	Costa Mesa	California
United States	Clinical Research Site #840-035	Cypress	Texas
United States	Clinical Research Site #840-053	Dallas	Texas
United States	Clinical Research Site #840-022	Detroit	Michigan
United States	Clinical Research Site	Doral	Florida
United States	Clinical Research Site #840-093	El Paso	Texas
United States	Clinical Research Site	Encino	California
United States	Clinical Research Site #840-044	Fairfax	Virginia
United States	Clinical Research Site	Hallandale Beach	Florida
United States	Clinical Research Site# 840-061	Honolulu	Hawaii
United States	Clinical Research Site	Houston	Texas
United States	Clinical Research Site #840-072	Houston	Texas
United States	Clinical Research Site #840-089	Kissimmee	Florida
United States	Clinical Research Site	Lady Lake	Florida
United States	Clinical Research Site #840-059	Lafayette	California
United States	Clinical Research Site #840-063	Las Vegas	Nevada
United States	Clinical Research Site	Little Rock	Arkansas
United States	Clinical Research Site #840-048	Lomita	California
United States	Clinical Research Site #840-095	Long Beach	California
United States	Clinical Research Site #840-004	Los Angeles	California
United States	Clinical Research Site #840-046	Los Angeles	California
United States	Clinical Research Site	Manhasset	New York
United States	Clinical Research Site #840-050	Meridian	Idaho
United States	Clinical Research Site #840-086	Mesquite	Texas
United States	Clinical Research Site	Miami	Florida
United States	Clinical Research Site	Miami	Florida
United States	Clinical Research Site #840-007	Miami	Florida
United States	Clinical Research Site #840-041	Miami	Florida
United States	Clinical Research Site #840-092	Miami	Florida
United States	Clinical Research Site #840-051	Naples	Florida
United States	Clinical Research Site #840-043	Neptune	New Jersey
United States	Clinical Research Site #840-056	New Bedford	Massachusetts
United States	Clinical Research Site	New Hyde Park	New York
United States	Clinical Research Site	Newton	Massachusetts
United States	Clinical Research Site #840-024	O'Fallon	Missouri
United States	Clinical Research Site #840-087	Orlando	Florida
United States	Clinical Research Site	Panorama City	California
United States	Clinical Research Site 840-028	Pensacola	Florida
United States	Clinical Research Site	Phoenix	Arizona
United States	Clinical Research Site	San Diego	California
United States	Clinical Research Site #840-016	Santa Ana	California
United States	Clinical Research Site	Tucson	Arizona
United States	Clinical Research Site #840-049	West Palm Beach	Florida
United States	Clinical Research Site #840-025	Wilmington	Delaware
United States	Clinical Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Chile,  Colombia,  Croatia,  Hungary,  Ireland,  Mexico,  Netherlands,  Slovakia,  Slovenia,  Spain, 

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