New drug combo aims to soothe Alzheimer's agitation

NCT ID NCT07284472

Recruiting now Symptom relief Sponsor: Exciva GmbH Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tests two experimental drugs, EXV-802 and EXV-801, to see if they can safely reduce agitation in people with Alzheimer's dementia. About 300 participants aged 55-90 with moderate to severe agitation will receive either the drug or a placebo twice daily for 6 weeks. The main goal is to measure changes in agitated behaviors using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Dextromethorphan (EXV-802) and deramciclane (EXV-801)
What this could lead to: If successful, this could provide a new treatment option to reduce agitation in people with Alzheimer's dementia, improving their quality of life and easing caregiver burden.
What could go wrong: This is an early-to-mid-stage trial with only 300 participants. The drugs may not prove more effective than placebo, or side effects could limit their use. Results may not apply to all Alzheimer's patients.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AGITATION ASSOCIATED WITH ALZHEIMER'S DISEASE DEMENTIA

Contacts and locations

Locations

Azienda Ospedaliera Cardinale Giovanni Panico
RECRUITING

Tricase, Lecce, 73039, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
RECRUITING

Palermo, Sicily, 90127, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
NOT_YET_RECRUITING

Rome, Lazio, 00133, Italy
Baycrest Centre for Geriatric Care
NOT_YET_RECRUITING

North York, Ontario, M6A 2E1, Canada
Brain-Soultherapy s.r.o.
RECRUITING

Kladno, Central Bohemia, 272 01, Czechia
Centrum Medyczne HCP Sp. z o.o.
RECRUITING

Poznan, Greater Poland Voivodeship, 61-485, Poland
Clinhouse Sp. z o.o.
RECRUITING

Zabrze, Silesian Voivodeship, 41-807, Poland
Crystal Comfort S.R.O.
RECRUITING

Vranov nad Topľou, Presov, 093 01, Slovakia
Curiositas ad sanum Studien und Beratungs GmbH
RECRUITING

Ebersberg, Bavaria, 85560, Germany
EPAMED s r.o.
NOT_YET_RECRUITING

Košice, Košice Region, 040 11, Slovakia
ETG Neuroscience Sp. z o.o.
RECRUITING

Warsaw, Masovian Voivodeship, 02-677, Poland
Esperanza Clinical
RECRUITING

Murrieta, California, 92562, United States
FNUSA - St. Anne's University Hospital Brno
NOT_YET_RECRUITING

Brno, South Moravian, 602 00, Czechia
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Main Campus
RECRUITING

Milan, Lombardy, 20122, Italy
FutureMeds Wroclaw
RECRUITING

Wroclaw, Lower Silesian Voivodeship, 53-673, Poland
Galen Research LLC
NOT_YET_RECRUITING

Chesterfield, Missouri, 63005, United States
Hospital Clinico San Carlos
RECRUITING

Madrid, 28040, Spain
Hospital Universitari Germans Trias i Pujol
NOT_YET_RECRUITING

Barcelona, Catalonia, 08916, Spain
Hospital Universitario Rio Hortega
RECRUITING

Valladolid, Castille and León, 47012, Spain
Hospital Universitario Virgen de la Macarena
RECRUITING

Seville, Andalusia, 41009, Spain
Hospital Virgen de la Concha
RECRUITING

Zamora, Castille and León, 49029, Spain
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
RECRUITING

Brescia, Lombardy, 25125, Italy
Insight Clinical Trials
RECRUITING

Independence, Ohio, 44131, United States
Integrative Clinical Trials
RECRUITING

Brooklyn, New York, 11229, United States
Josephson Wallack Munshower Neurology PC
RECRUITING

Indianapolis, Indiana, 46260, United States
Kawartha Centre
RECRUITING

Peterborough, Ontario, K9H 294, Canada
Krakowska Akademia Neurologii
RECRUITING

Krakow, Lesser Poland Voivodeship, 31-505, Poland
MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o.
NOT_YET_RECRUITING

Banská Bystrica, Banská Bystrica Region, 974 04, Slovakia
Manhattan Behavioral Medicine
RECRUITING

New York, New York, 10036, United States
Medicinske Centrum Konzilium, s.r.o.
NOT_YET_RECRUITING

Dubnica nad Váhom, Trenčín Region, 018 41, Slovakia
Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres
RECRUITING

Böblingen, Baden-Wurttemberg, 71034, Germany
NZOZ Neuromed M. i M. Nastaj Spolka Partnerska
NOT_YET_RECRUITING

Lublin, Lublin Voivodeship, 20-064, Poland
NZOZ Wroclawskie Centrum Alzheimerowskie
RECRUITING

Wroclaw, Lower Silesian Voivodeship, 53-659, Poland
NeuropsychiatrieHK, sro
RECRUITING

Hradec Králové, Hradec Králové Region, 500 02, Czechia
Ontario Shores Centre for Mental Health Sciences
NOT_YET_RECRUITING

Whitby, Ontario, L1N 5S9, Canada
Oregon Health & Science University
NOT_YET_RECRUITING

Portland, Oregon, 97239, United States
Praxis Dr. med. Kirsten Hahn
RECRUITING

Berlin, State of Berlin, 13187, Germany
Precise Research Centers
RECRUITING

Flowood, Mississippi, 39232, United States
Psychiatrie-Ambulance s.r.o
NOT_YET_RECRUITING

Pilsen, Plzeň Region, 301 00, Czechia
RCMed Oddzial Sochaczew
RECRUITING

Sochaczew, Masovian Voivodeship, 69-500, Poland
Scottish Brain Sciences
RECRUITING

Edinburgh, Midlothian, EH12 5PJ, United Kingdom
Scottish Brain Sciences
RECRUITING

Aberdeen, North East Scotland, AB25 2XE, United Kingdom
Silmedic Sp. z o.o.
RECRUITING

Katowice, Silesian Voivodeship, 40-282, Poland
Sunnybrook Health Sciences Centre
NOT_YET_RECRUITING

North York, Ontario, M4N 3M5, Canada
TUM Klinikum rechts der Isar
NOT_YET_RECRUITING

München, Bavaria, 81675, Germany
The Memory Clinic
RECRUITING

Bennington, Vermont, 05201, United States
Universita degli Studi di Roma ''La Sapienza" - Azienda Ospedaliera Sant'Andrea
NOT_YET_RECRUITING

Rome, Lazio, 00189, Italy
Univerzitna nemocnica Bratislava
NOT_YET_RECRUITING

Bratislava, Bratislava Kraj, 813 69, Slovakia
Velocity Clinical Research, Staszów
RECRUITING

Staszów, Świętokrzyskie Voivodeship, 28-200, Poland

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New pill aims to soothe agitation in Alzheimer's patients