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Study on the Effectiveness and Safety of AVP-786 (Quinidine Sulfate and Deudextromethorphan Hydrobromide) for Treating Agitation in Alzheimer's Dementia Patients

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of agitation in patients with dementia of the Alzheimer's type. The treatment being tested is a medication called AVP-786, which is a combination of two active substances: quinidine sulfate and deudextromethorphan hydrobromide. The study will compare the effects of AVP-786 to a placebo to determine its effectiveness, safety, and how well patients can tolerate it.

The purpose of the study is to evaluate how well AVP-786 works in reducing agitation symptoms in patients with Alzheimer's-related dementia. Participants in the study will receive either the AVP-786 capsules or a placebo, and neither the participants nor the researchers will know which treatment each participant is receiving. This is known as a double-blind study. The study will take place over a period of time, during which participants will be monitored for changes in their symptoms and any side effects they may experience.

Throughout the study, participants will be asked to take the medication orally, in capsule form, and will be regularly assessed by healthcare professionals. The study aims to provide valuable information on whether AVP-786 can be a beneficial treatment option for managing agitation in patients with Alzheimer's disease. The results will help determine if this medication can improve the quality of life for those affected by this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to receive either the study medication, AVP-786, or a placebo. This process is double-blind, meaning neither the patient nor the study team will know which treatment is being administered.

  2. Step 2

    Medication administration

    The patient will take the assigned medication orally in the form of a capsule. The active medication, AVP-786, contains deudextromethorphan hydrobromide and quinidine sulfate. The dosage and frequency of administration will be determined by the study protocol and communicated to the patient by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's condition will be regularly monitored. This includes assessments of agitation levels using standardized scales, such as the Cohen-Mansfield Agitation Inventory (CMAI) and the Clinical Global Impression of Severity (CGI-S).

    The primary focus is on changes in agitation from the start of the study to the end of the treatment period.

  4. Step 4

    Completion of the study

    At the end of the study period, the patient will undergo a final evaluation to assess the overall impact of the treatment on agitation symptoms.

    The study is expected to conclude by March 2026, at which point all data will be analyzed to determine the efficacy and safety of AVP-786.

Who can join the trial?

14 criteria

  • Participants must be men or women aged between 50 and 90 years old.
  • Participants should not have any significant issues found in heart tests called ECGs.
  • Women who can have children and are sexually active must use effective birth control methods before and during the study, and for 30 days after the last dose of the study drug. This includes using two methods like birth control pills, implants, or condoms with spermicide.
  • Participants must be willing to follow rules about medications they can or cannot take during the study.
  • A caregiver must be available to help with study procedures and spend at least 2 hours a day with the participant for at least 4 days a week.
  • Participants and caregivers must agree to sign a consent form after understanding the study details and risks. If the participant cannot sign, a representative can do so.
  • Participants must have a diagnosis of probable Alzheimer's disease and can live at home or in a care facility.
  • Participants need a score between 8 and 24 on a test called MMSE, which checks mental function.
  • Participants must have noticeable agitation that affects daily life for at least 2 weeks before the study starts.
  • Participants should need medication for agitation after trying other methods like group activities or music therapy.
  • The diagnosis of agitation must fit a specific definition by the International Psychogeriatric Association.
  • Participants need a certain score on a test called NPI-AA, which measures agitation.
  • Participants must meet an additional hidden eligibility requirement.
  • Participants should have stable heart, lung, liver, and kidney function according to the study doctor's judgment.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of dementia other than Alzheimer's.
  • Patients who have severe medical conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study medication.
  • Patients who have a significant psychiatric disorder other than dementia.
  • Patients who have a history of seizures or epilepsy.
  • Patients who are unable to comply with the study procedures.
  • Patients who have a recent history of heart problems.
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Investigated drugs

AVP-786: This medication is being studied for its potential to help reduce agitation in patients with Alzheimer's disease. It is a combination of two components: deudextromethorphan hydrobromide and quinidine sulfate. Deudextromethorphan is thought to affect certain brain chemicals that may be involved in mood and behavior, while quinidine helps to increase the levels of deudextromethorphan in the body, making it more effective. The trial aims to determine if AVP-786 can safely and effectively manage symptoms of agitation in individuals with Alzheimer's-related dementia.

What is already known about the treatment

AVP-786 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating agitation in patients with Alzheimer's-related dementia. It is in the advanced stages of research, specifically a Phase 3 trial, which indicates it is being evaluated for safety and efficacy before potential approval for general medical use. The main therapeutic indication for AVP-786 is to manage agitation symptoms in Alzheimer's patients. At the molecular level, it combines deudextromethorphan hydrobromide and quinidine sulfate, which work together to modulate neurotransmitter activity in the brain, potentially reducing agitation. Pharmacologically, it is classified as a central nervous system agent with properties that affect brain chemistry to help manage behavioral symptoms.

Investigated diseases

Agitation in Patients With Dementia of the Alzheimer's Type – This condition involves excessive restlessness and emotional distress in individuals with Alzheimer's disease, a common form of dementia. Patients may exhibit behaviors such as pacing, shouting, or becoming physically aggressive. These symptoms can fluctuate in intensity and may be triggered by environmental changes or internal discomfort. Agitation can significantly impact the quality of life for both patients and their caregivers. It often requires careful management to ensure the safety and well-being of those affected. Understanding the underlying causes of agitation is crucial for developing effective strategies to alleviate these symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504990-19-00Protocol code20-AVP-786-306Estimated enrolment750 patientsSponsorOtsuka Pharmaceutical Development & Commercialization Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).