Assessment of 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

Completed · Phase 3 · Has a placebo group

Conditions studied: Agitation in Patients With Dementia of the Alzheimer's Type

In brief

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.

Key facts

Study ID

NCT03393520

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

601

Starts

2017-10-13

Expected to finish

2023-12-14

Last updated by the study team

2024-11-20

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
• Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to baseline that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator
• The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.
• A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of ≥ 4 (moderately ill) at screening and baseline
• Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.
• Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

You may not qualify if…

• 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 AD (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, 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

Where it is running

• Liv Generations of Agritopia / CCT #573 — Gilbert, Arizona, United States
• Liv Generations of Ahwatukee / CCT #784 — Phoenix, Arizona, United States
• Perseverance Research Center — Scottsdale, Arizona, United States
• Medical Advancement Center of Arizona #820 — Tempe, Arizona, United States
• Clinical Trials Inc. — Little Rock, Arkansas, United States
• Advanced Research Center, Inc #835 — Anaheim, California, United States
• ATP Clinical Research, Inc #763 — Costa Mesa, California, United States
• Paradigm Clinical Research Centers, Inc. — La Mesa, California, United States
• Sunwise Clinical Research #831 — Lafayette, California, United States
• Torrance Clinical Research Institute, Inc. #826 — Lomita, California, United States
• Rohun Medical Corporation Site #770 — Long Beach, California, United States
• Alliance for Wellness, Inc dba Alliance for Research #789 — Long Beach, California, United States
• Havana Research Institute — Pasadena, California, United States
• Neurology of Central Florida Rsch Ctr # 803 — Altamonte Springs, Florida, United States
• Negron Research Services / Humanity Clinical Research #766 — Aventura, Florida, United States
• SFM Clinical Research, LLC #563 — Boca Raton, Florida, United States
• Helix Biomedics LLC — Boynton Beach, Florida, United States
• Bradenton Research Center #834 — Bradenton, Florida, United States
• Clinical Research of Brandon #838 — Brandon, Florida, United States
• ASCLEPES Research Center #806 — Brooksville, Florida, United States
• Beautiful Minds Clinical Research Center #808 — Cutler Bay, Florida, United States
• Science Connections, LLC #814 — Doral, Florida, United States
• ConSalud Medical Research #773 — Hialeah, Florida, United States
• Direct Helpers Research Center # 801 — Hialeah, Florida, United States
• MD First Research #767 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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