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
curiositas ad sanum Studien und Beratungs GmbH Haag in Obb Germany
Rcmed Oddzial Sochaczew Sochaczew Poland
Pharmakologisches Studienzentrum Chemnitz GmbH Chemnitz Germany
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
NZOZ Wrocławskie Centrum Alzheimerowskie Wroclaw Poland
Era Nmzuaiikfcju Svv z oiwr Warsaw Poland
Mkvbr Bthxs Duxvimip nbqyeahfhzcr awnbvpymdx shzrqa Banska Bystrica Slovakia
Ptlxvrwmtxztcyqzcodld stsaxc Plzen Czechia
Nrrufpcvgtyoruj Piiiji Fhpi Drh Kuoeead Huxu Berlin Germany
Ebelmh skhlws Kosice Slovakia
Chncmkc Mddllljg Hul Suz z otno Poznan Poland
Bbosjyinocwajlkpp sgtiqj Kladno Czechia
Cdinvvs Ckpmzmi silhcf Vranov Nad Toplou Slovakia
Niyttisccvhytxgtjq sxhklb Prazske Predmesti Czechia
Gtzndwmovjaztu crmbuou Prague Czechia
Kcsuwlo Aucczvnbft Bratislava Slovakia
Zmtrmoa fvf Pdycjaqzvet Ehisfufqrop Emmendingen Germany
Hhzkkwna Sgz Jbfj dl Dsuh Dn Sozmrnf Sevilla Spain
Stfzesobqaqrvr Dqw Bmcgwfp Gzwh Böblingen Germany
Kjnsmcoix seylyt 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
Recruiting
01.05.2026
Germany Germany
Recruiting
01.05.2026
Italy Italy
Recruiting
01.05.2026
Poland Poland
Recruiting
01.05.2026
Slovakia Slovakia
Recruiting
01.05.2026
Spain Spain
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.

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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