Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on AVP-786 for Treating Agitation in Alzheimer's Dementia Patients

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 understand 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 medication or a placebo. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will take the medication in capsule form by mouth. The study will last for a set period, during which participants will be monitored for any changes in their symptoms and any side effects they may experience. The goal is to determine if AVP-786 can help manage agitation in patients with Alzheimer's-related dementia more effectively than a placebo.

The research process

The trial runs in 6 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 informed about the trial's purpose, procedures, and potential risks. The patient or their authorized representative must provide consent to participate.

    The patient must meet specific criteria, including age between 50 and 90 years, a diagnosis of probable Alzheimer's disease, and clinically significant agitation.

  2. Step 2

    Baseline assessment

    A baseline assessment will be conducted to evaluate the patient's current condition. This includes measuring the severity of agitation using specific scales.

    The patient's medical history and current medications will be reviewed to ensure eligibility.

  3. Step 3

    Randomization

    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.

  4. Step 4

    Medication administration

    The patient will take the assigned medication orally in the form of a capsule. The specific dosage and frequency will be determined by the study protocol.

    The treatment period will continue for a specified duration, during which the patient will be monitored for any changes in symptoms and potential side effects.

  5. Step 5

    Regular assessments

    Throughout the trial, the patient will undergo regular assessments to monitor the efficacy and safety of the treatment. This includes evaluating changes in agitation levels and overall health.

    The patient's caregiver will assist in reporting any observations and ensuring adherence to the study protocol.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, a final evaluation will be conducted to assess the overall impact of the medication on the patient's agitation.

    The results will contribute to understanding the effectiveness and safety of AVP-786 for treating agitation in patients with Alzheimer's disease.

Who can join the trial?

14 criteria

  • Participants must be men or women aged between 50 and 90 years old.
  • A caregiver must be willing and able to help with all study procedures, including giving the study medication and avoiding any prohibited medications. The caregiver should spend at least 2 hours a day with the patient for at least 4 days a week.
  • The patient and caregiver must agree to sign a consent form after understanding the study's nature and risks. If the patient cannot sign, they can give their agreement, or a representative can agree on their behalf.
  • The patient must have a diagnosis of probable Alzheimer's disease, based on specific criteria from 2011. They can live at home or in a care facility.
  • The patient must have a score between 8 and 24 on a test called the MMSE, which checks mental function, at the start and during the study.
  • The patient must have noticeable, moderate-to-severe agitation for at least 2 weeks before the study, which affects their daily life.
  • The patient must need medication to treat agitation, after checking for other causes like pain or infection and trying non-drug methods like music therapy.
  • The diagnosis of agitation must match a specific definition by the International Psychogeriatric Association.
  • The patient must have a certain score on a test called the NPI-AA, which measures agitation, at the start and during the study.
  • The patient must meet an additional hidden eligibility requirement.
  • The patient must have stable heart, lung, liver, and kidney function.
  • The patient must not have any significant issues on heart tests called ECGs at the start and during the study.
  • Women who can have children and are sexually active must use effective birth control for at least 1 month before the study, during the study, and for 30 days after the last dose of the study drug. They must use two methods of birth control, like birth control pills and condoms. Women who are sterile, postmenopausal, or practice true abstinence are exempt. Pregnant or breastfeeding women cannot participate.
  • Patients must be willing and able to follow all rules about medications they can or cannot take before and during the study.

Who cannot join the trial?

9 criteria

  • Patients who do not have **dementia of the Alzheimer's type**. Dementia is a condition that affects memory and thinking, and Alzheimer's is a specific type of dementia.
  • Patients who are not experiencing **agitation**. Agitation means feeling restless or upset.
  • Patients who are not within the specified **age range** for the study. The study has specific age limits for participants.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are taking medications that could interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have participated in another clinical trial recently.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

AVP-786 is a medication being studied for its potential to help reduce agitation in patients with Alzheimer's-related dementia. It is a combination of two components: deudextromethorphan hydrobromide and quinidine sulfate. The purpose of this medication in the trial is to assess how effective and safe it is in managing symptoms of agitation in these patients.

What is already known about the treatment

AVP-786 – This medication is administered orally and is currently being studied in a Phase 3 clinical trial. It is being evaluated for its effectiveness in treating agitation in patients with dementia of the Alzheimer's type. AVP-786 combines deudextromethorphan hydrobromide and quinidine sulfate, working by modulating neurotransmitter activity in the brain to help reduce symptoms of agitation. It falls under the pharmacological classification of central nervous system agents.

Investigated diseases

Agitation in Patients With Dementia of the Alzheimer's Type – This condition involves increased restlessness, irritability, and sometimes aggressive behavior in individuals with Alzheimer's disease. It is characterized by a noticeable change in behavior, where patients may become more easily upset or anxious. The progression of agitation can vary, with symptoms sometimes worsening in the late afternoon or evening, a phenomenon known as "sundowning." Patients may exhibit pacing, verbal outbursts, or resistance to care. These behaviors can be distressing for both the patient and caregivers, often requiring adjustments in the living environment or daily routine. Understanding and managing triggers can help in reducing the frequency and intensity of agitation episodes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504991-31-00Protocol code20-AVP-786-307Estimated enrolment750 patientsSponsorOtsuka Pharmaceutical Development & Commercialization Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.