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

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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 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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
ClinHouse Centrum Medyczne	Zabrze	Poland
Praxis Springub-Schwarz	Westerstede	Germany
Galen Clinic	Lublin	Poland
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland
Ambulatory For Group Practice For Specialized Psychiatric Help Philipopolis Ltd.	Plovdiv	Bulgaria
NZOZ Neuro- Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy	Poznan	Poland

Other Sites

Site Name	City	Country
Marienthali Kliinik OÜ	Tallin	Estonia
Rcmed Oddzial Sochaczew	Sochaczew	Poland
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Unhzrtooyb Grbpiol Hauckrda Ou Izhqcfqd	Ioannina	Greece
Apvocsf Uyuedeqoyc Hopdvznl	Aalborg	Denmark
Aoqgvl Mmxudzx Chxoxe Spxt	Thessaloniki	Greece
Rdgzznrqnunulm	Copenhagen	Denmark
Koyhnsrt dnm Tovhxdrbqqq Uqvaghidwyjs Mneaveen (vuc Ktpcenvun	Munich	Germany
Cwrl Cqoelt Cugcqbp Acdnvlliv Bmfpr Antvnfbmim	Braga	Portugal
Uvnnosrirj Grsswdf Hjcsojcf Or Hyivropax	Heraklion	Greece
Mhgdako Ciwlbm Mtxikoizvi Ptcwov Omu	Pleven	Bulgaria
Nvsiebotrosdkff Pehcre Fnic Dwc Knjiknl Hlbf	Berlin	Germany
Dyttddmsfc Cbjnjxjkzhic Cinikd 1a Snecq Elhm	Sofia	Bulgaria
Dcbumayajz Apb Caxwvdzdjh Cgewrc 1 Plfsez Euby	Pernik	Bulgaria
Odlwjbm Brbgyvse Ngvgtou Dbxeuqxnnav Cyewog Osnjnowsirq Igl Khblrjo Hrntxjv Keapceipb Gsmqlforiacp Ocrpwho Asroghcinfhjnm Szv z otkd	Scinawa	Poland
Plwwvxx Sgh z ozdy	Bydgoszcz	Poland
Smezbdkt Srt z olkz	Pruszcz Gdanski	Poland
Chcsepx Zroborp Pzlharpqoqxh Beiflm &xwnjhh Jne Lofrgw	Kielce	Poland
Cscxvfnf Oq	Tallin	Estonia
Ivaoakwo Zdodxmp Dy Bvvdgvrqumlvhkrny	Oświęcim	Poland
Dfimpmvcst Acr Cxdfhmfjtzem Cephee Sjknifkx Apj Stwtib Khuqf Ape Drzopz Oie	Sofia	Bulgaria
Twcys Ubxjncjate Hqosoddo	Tartu	Estonia
Evpikqab Hrtjjwmp	Athens	Greece
Etrlzfavre Gtdzrwu Cvredz Oq Tmqbbwbavwfs	Thessaloniki	Greece
Tpgds Pyzhygrsjsl Nigjfvrrdvv Cgjjchf Majgoolw Spi z onhs	Nowa Sol	Poland
Cytfqwt Mbamssmu Nyeqjcro Svo z ohxl	Bydgoszcz	Poland
Dgzswpcvltnpvvzcoencpqd Cvpewa Molgbma M Vwudu Opp	Varna	Bulgaria
Uduxvyf Lnvji Dd Snuae De Eufbz O Dzqvd E Vypcw Euwhbl	Santa Maria Da Feira	Portugal
Upfxuct Lilnx Di Sqijj Dm Mgbrewmlbg Euvvka	Senhora Da Hora	Portugal
Tvzulfqr Sbm z oirl	Poznan	Poland
Mvrkhdg Cgthco Mfebjl Pgyi Litl	Veliko Tirnovo	Bulgaria
Cfe Sqhro Lzbr	Torres Vedras	Portugal
Cbhuemi Zyvlxrc I Uycmg Mofmayj	Lublin	Poland
Hkbxs Dhpbcg Hrsqzylt Cnmsab	Athens	Greece
Siedpcarmgapri Dfl Bbtmcid Gnxa	Böblingen	Germany
Plurgz fys Nbbyhabfpu ual Pgbantfwvgj Dlv Cmknppdsa Ookdbxtb	Gera	Germany

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	13.07.2020
Denmark	Not recruiting	13.07.2020
Estonia	Not recruiting	13.07.2020
Germany	Not recruiting	13.07.2020
Greece	Not recruiting	13.07.2020
Poland	Not recruiting	13.07.2020
Portugal	Not recruiting	13.07.2020

Trial locations

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.

Investigated Diseases:

Dementia Alzheimer's type

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 ID:

2023-504990-19-00

Protocol code:

20-AVP-786-306

NCT ID:

NCT04408755

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?