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New drug combo aims to soothe Alzheimer's agitation

NCT ID NCT07284472

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker or a wheelchair. 2. A previously established diagnosis of AD dementia. 3. The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization 4. The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation. 5. Caregiver who is able and willing to comply with all required study procedures and who is in contact with the participant at least on four individual days for at least two hours per day. Exclusion criteria: 1. The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia. 2. The participant has symptoms of agitation that are not secondary to AD dementia 3. The participant has a history of uncontrolled seizures or a history of epilepsy. 4. The participant has a major medical illness or unstable medical condition

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    49 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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