#1 Clinical Trials Search in Europe

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

1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Poliklinika Vlatka Cavka d.o.o. Zagreb Croatia
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
UNIVERZITETNI KLINICNI CENTER MARIBOR Maribor Slovenia
Hospital Universitario Rio Hortega Valladolid Spain
Complejo Asistencial De Zamora Hospital Provincial De Zamora Zamora Spain
Accellacare Espana S.L. Alcobendas Spain
Crystal Comfort s.r.o. Vranov Nad Toplou Slovakia
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Hospital General Universitario De Alicante Alicante Spain
KBC Zagreb Zagreb Croatia
Tallaght University Hospital Dublin Ireland
St James’s Hospital Dublin Ireland
Clinexpert Kft. Budapest Hungary
Brain Research Center Den Bosch B.V. s-Hertogenbosch The Netherlands
Hospital Universitario Virgen Macarena Sevilla Spain
Virgen del Rocío University Hospital Sevilla Spain
Semmelweis University Budapest Hungary
University Medical Center Ljubljana Ljubljana Slovenia
Anima Alken Belgium
Servei De Salut De Les Illes Balears Palma Spain
University Of Szeged Szeged Hungary
Epamed s.r.o. Kosice Slovakia
Klinika za psihijatriju Vrapce Zagreb Croatia
Pula General Hospital Ospedale Generale di Pola Pula Croatia
Hxlwbkqy Uvkjznaldpymv Dj Le Puxetcnn Madrid Spain
Pbpucdnjlf Kkwv Pecs Hungary
Sfs Fttzuarwwdicpxk Hntqheue Cork Ireland
Mhfod Ujerrktjhs Hshbgnkt Cork Ireland
Nejnolvqeq arykidofd Kxaveuzt Nova Gorica Slovenia
Shwseyh Bshjpfyecm Mfnpem Sbgfou Murska Sobota Slovenia
Prsrbuiyqcns Blbrfeeidr Bavjsby Begunje Na Gorenjskem Slovenia
Clefsaw Mzgzdlrqnt Sged Zaragoza Spain
Kwhuolugu swffvr Nova Dubnica Slovakia
Pryfjasijn swndli Rimavska Sobota Slovakia
Mizzh Bdfoe Dapjvalr npcnysaoznrv angglhzcae slieft Banska Bystrica Slovakia
Cjwqvou Zkdrmds Rcxvbs sbgnzc Bardejov Slovakia
Bbgigimthgo Vogvgbroc Omfavmtujtxh Kecskemet Hungary
Kxdzlwow bmzslzxu cpfkxj Rhgzqf (rkntjcla Hncpmffe Crxkri Rzxgyoo Rijeka Croatia
Fmiytmatb Pgdo Lc Innvueoijgkil Bjgrmrxif Dql Hmxmxxnm Uezdtgexggmve Lm Plu Madrid Spain
Htrttpdw Ueavszvtrezfg dlk Hgbhqdm Coslada (Madrid) Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
11.09.2020
Croatia Croatia
Not recruiting
11.09.2020
Hungary Hungary
Not recruiting
11.09.2020
Ireland Ireland
Not recruiting
11.09.2020
Slovakia Slovakia
Not recruiting
11.09.2020
Slovenia Slovenia
Not recruiting
11.09.2020
Spain Spain
Not recruiting
11.09.2020
The Netherlands The Netherlands
Not recruiting
11.09.2020

Trial locations

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.

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 ID:
2023-504991-31-00
Protocol code:
20-AVP-786-307
NCT ID:
NCT04464564
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study testing trontinemab compared to placebo in patients with early Alzheimer’s disease including mild cognitive impairment and mild dementia

    Recruiting

    1 1 1
    Investigated drugs:
    Denmark France Germany Italy Poland Spain

  • Study of Trontinemab Compared to Placebo for Patients with Early Symptomatic Alzheimer’s Disease

    Recruiting

    1 1 1
    Investigated drugs:
    Denmark France Germany Italy The Netherlands Poland +1