A study to evaluate the safety and effectiveness of dextromethorphan, deramciclane fumarate, and deramciclane in treating agitation in people with Alzheimer’s disease

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What is this study about?

This study is being conducted to evaluate the safety and effectiveness of two experimental medications, EXV-802 and EXV-801, for treating agitation in individuals living with Alzheimer’s disease dementia. Agitation refers to feelings of restlessness, irritability, or anxious behavior that can occur in people with this type of memory-related brain disorder. The medication EXV-802 contains a combination of dextromethorphan and deramciclane fumarate, while EXV-801 contains deramciclane. Participants in the study may receive one of these active treatments or a placebo.

The study follows a double-blind design, which means that neither the participants nor the researchers know who is receiving the active medication and who is receiving the placebo. This method is used to prevent bias in the results. During the course of the study, participants will take an oral capsule for a period of time to monitor how the medications affect their symptoms and general well-being.

Who Can Join the Study?

  • You must be an adult male or female between the ages of 55 and 90 years.
  • You must be able to move around independently, either by walking on your own, using a walker (a device that helps you walk), or using a wheelchair.
  • You must have a previously confirmed diagnosis of Alzheimer’s Disease dementia, which is a brain condition that affects memory, thinking, and behavior.
  • You must experience agitation, which refers to feeling restless, upset, or behaving in an anxious way, that is severe enough to require treatment with medicines.
  • The level of your agitation must be at least moderate, meaning it is more than mild but not yet extreme.

Who Cannot Join the Study?

  • The participant has a confirmed diagnosis of a type of dementia, which is a condition that causes a decline in memory and thinking skills, that is not Alzheimer’s disease.
  • The participant experiences agitation, which refers to feelings of restlessness or nervousness, that is caused by a psychiatric condition, or a mental health disorder, other than Alzheimer’s disease.
  • The participant has a history of epilepsy or uncontrolled seizures, which are sudden, uncontrolled electrical disturbances in the brain that can cause changes in behavior or movement.
  • The participant does not have a caregiver, which is a person who provides regular assistance and support, to help meet their daily needs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Etg Neuroscience Sp. z o.o. Warsaw Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
University Hospital Bratislava Bratislava Slovakia
Hospital Universitario Rio Hortega Valladolid Spain
Rcmed Oddzial Sochaczew Sochaczew Poland
Centrum Medyczne Hcp Sp. z o.o. Poznan Poland
Silmedic Sp. z o.o. Katowice Poland
Complejo Asistencial De Zamora Hospital Provincial De Zamora Zamora Spain
NeuropsychiatrieHK s.r.o. Prazske Predmesti Czechia
Crystal Comfort s.r.o. Vranov Nad Toplou Slovakia
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
curiositas ad sanum Studien und Beratungs GmbH Haag in Obb Germany
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Nervenärztliche Praxis Frau Dr. Kirsten HahN Berlin Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Provincia Lombardo Veneta Dell’ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli Brescia Italy
Gerontologické centrum Prague Czechia
Klinika AuraMedica Bratislava Slovakia
Zentrum für Psychiatrie Emmendingen Emmendingen Germany
Hospital San Juan de Dios De Sevilla Sevilla Spain
Epamed s.r.o. Kosice Slovakia
NZOZ Wrocławskie Centrum Alzheimerowskie Wroclaw Poland
Btfgscuhytamrvujr svxtqb Kladno Czechia
Mware Bwwjt Dutrtvid nwguyxebxlwb afdqtvbafh saovil Banska Bystrica Slovakia
Hwohcrue Umablsvywlgjx Hbsnjgkg Tmmuc y Pzkyqt Icqcyitt Cqctfb dkvsjgdfnazdmybyp (qftc Badalona Spain
Pqycmkljzoepsyatlmmfm sbhcvd Plzen Czechia
Stmvpmdpxpxtva Dpv Bsuwhrv Gzek Böblingen Germany
Keyukjelk swcrvo Dubnica nad Váhom Slovakia

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
01.05.2026
Germany Germany
Not yet recruiting
01.05.2026
Italy Italy
Not yet recruiting
01.05.2026
Poland Poland
Not yet recruiting
01.05.2026
Slovakia Slovakia
Not yet recruiting
01.05.2026
Spain Spain
Not yet recruiting
01.05.2026

Trial locations

EXV-802 is an oral capsule that combines two different medicines used to help treat agitation in people living with Alzheimer’s disease.

EXV-801 is an oral capsule containing a single medicine intended to help manage agitation in people living with Alzheimer’s disease.

Investigated diseases:

Agitation in Alzheimer’s Disease Dementia – This condition involves a state of restlessness, irritability, or emotional distress occurring in individuals with Alzheimer’s disease. It often manifests as repetitive behaviors, pacing, or vocal outbursts. As the underlying dementia progresses, these behavioral symptoms may increase in frequency and intensity. The agitation can be triggered by various environmental factors or changes in the person’s mental state. It represents a neuropsychiatric symptom that complicates the daily management of the primary cognitive decline.

Trial ID:
2024-517388-22-00
Protocol code:
EXV802-2-1
NCT ID:
NCT07284472
Trial Phase:
Therapeutic use (Phase IV)

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